The clinical effect of Nano micelles containing curcumin as a therapeutic supplement in patients with COVID-19 and the immune responses balance changes following treatment: A structured summary of a study protocol for a randomised controlled trial

Abstract Objectives To investigates the effectiveness of curcumin-containing Nanomicelles as a therapeutic supplement in the treatment of patients with COVID-19 and its effect on immune responses balance changes following treatment. Trial design This study is conducted as a prospective, placebo-controlled with parallel group, single-center randomized clinical trial on COVID-19 patients. Participants Patients are selected from the COVID-19 ward of Shahid Mohammadi Hospital in Bandar Abbas, Iran. Inclusion criteria: 1. Real time PCR-approved positive COVID-19 test. 2. Both gender 3. Age between 18 and 75 years 4. Signing a written consent 5. Lack of participation in other clinical trials Exclusion criteria: 1. Pregnancy or lactation 2. Allergy to turmeric or curcumin 3. Smoking 4. Patient connected to the ventilator 5. SaO2 less than 90% or PaO2 less than 8 kPa 6. Having comorbidities (such as severe renal failure, Glomerular filtration rate less than 30 ml/min, liver failure, Congestive heart failure, or Chronic obstructive pulmonary disease) 7. History of gallstones 8. History of gastritis or active gastrointestinal ulcer Intervention and comparator In addition to the routine standard treatments for COVID-19, in the intervention group, 40mg nanomicelles containing curcumin (SinaCurcumin Capsule, Exir Nano Sina Company, Iran), four times per day (after breakfast, lunch, dinner and before bedtime) and in the placebo group as the control group, capsules with the same appearance and characteristics (Placebo capsules, Exir Nano Sina Company, Iran) are prescribed for two weeks. Main outcomes The effectiveness of Nano micelles containing curcumin treatment will be evaluated as daily clinical examinations of patients in both groups and, on days 0, 7 and 14, complete clinical symptoms and laboratory findings including peripheral blood and serum parameters such as inflammatory markers will be measured and recorded. Moreover, in order to evaluate the balance of immune responses changes following treatments, serum level of IFN-γ, IL-17, Il-4 and TGF-β serum cytokines will be measured in both groups at time points of 0, 7 and 14 days post treatment. Gene expression of t-bet, GATA-3, FoxP3 and ROR- γT will also be measured at mentioned time points to assess the shift of T helper1, T helper2, T regulatory and T helper 17 immune responses following treatment. Randomisation Randomized trials will be performed on 40 COVID-19 patients which will be randomized using encoded sealed boxes with computer generated random digits with 1:1 allocation ratio. In order to randomization, placebo and SinaCurcumin Capsules will be numbered first by computer generated random digits. SinaCurcumin and placebo will then be stored and numbered in sealed packages based on generated random numbers. Finally, according to the order in which patients enter the study, packages are given to patients based on their number. Blinding (masking) The present study will be blind for all patients, physicians and nurses, laboratory technicians and statisticians. Numbers to be randomised (sample size) A total of 40 patients will be included in the study, 20 of them will be randomly assigned to the intervention group and 20 to the placebo group. Trial status This is Version 1.0 of protocol dated 21 May 2020. The recruitment was started June 24, 2020 and is expected to be completed by October 31, 2020. Trial registration This present clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with the registration code of “IRCT20200611047735N1”, https://www.irct.ir/trial/48843. Dated: 19 June 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-020-04934-7 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Mahsa Miryan ◽

Davood Soleimani ◽

Leila Dehghani ◽

Karim Sohrabi ◽

Farzin Khorvash ◽

...

Keyword(s):

Clinical Trial ◽

Sample Size ◽

Clinical Symptoms ◽

Intervention Group ◽

Trial Registration ◽

Control Group ◽

Double Blind ◽

Double Blind Placebo ◽

Placebo Tablet ◽

Full Protocol

Abstract Objectives This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19). Trial design This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial. Participants Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran. Intervention and comparator Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran. Main outcomes The main outcomes are changes in the coronavirus disease’s clinical symptoms including duration and severity from baseline to the end of 2 weeks. Randomization Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial’s pharmacist with the use of random-number tables. Blinding (masking) The trial-group assignment will be concealed from all participants, clinicians, and investigators throughout the trial. To ensure blinding, randomization sequences will be kept in identical, opaque, sealed, sequentially numbered envelopes. Only the trial's pharmacist has access to the randomization list. Also, the placebo tablet will be similar to the propolis tablet in terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labelling, and packaging. Numbers to be randomized (sample size) The calculated total sample size is 80 patients, with 40 patients in each group. Trial status The protocol is Version 1.0, October 10, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by March 21, 2021. Trial registration The name of the trial register: The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial. IRCT registration number: IRCT20200802048267N1. Date of trial registration: 20 October 2020, retrospectively registered. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05372-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Gholamreza Askari ◽

Babak Alikiaii ◽

Davood Soleimani ◽

Amirhossein Sahebkar ◽

Mahdiye Mirjalili ◽

...

Keyword(s):

Clinical Trial ◽

Mortality Rate ◽

Intervention Group ◽

Blood Oxygen Saturation ◽

Double Blind ◽

Group Assignment ◽

Double Blind Clinical Trial ◽

History Of ◽

Full Protocol ◽

Nurses And Physicians

Abstract Objectives This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the intensive care unit (ICU). Trial design This study is a randomized, placebo-controlled, double-blind, parallel-arm clinical trial. Participants The study participants will be recruited from patients admitted to the ICU of Al-Zahra hospital with a definitive diagnosis of COVID-19. The inclusion criteria are aged between 20 and 75 years, confirmation of COVID-19 based on the PCR test, and admitted to the ICU. The exclusion criteria include the present use of parenteral nutrition support, a history of underlying diseases such as congenital disorders, immune diseases, renal and hepatic insufficiency, and pancreatitis, a history of sensitivity to herbal remedies such as turmeric and pepper, and regular use of anticoagulant drugs such as warfarin. This study will be performed in the Al-Zahra hospital, an academic hospital affiliated with Isfahan University of Medical Sciences, Isfahan, Iran. Intervention and comparator Sixty eligible patients will be randomly assigned, in a 1:1 ratio, to receive curcumin-piperine capsules (three capsules/day; each capsules containing 500 mg curcumin plus 5 mg piperine; in total 1500 mg curcumin and 15 mg piperine/daily) for seven days (n=30) or matching placebo capsules (three capsules/day; each capsules containing 505 mg maltodextrin; totally 1515 mg, maltodextrin/ daily) for same duration (n=30). Capsules will be administered after oral or enteral feeding at 9, 15 and 21 o’clock. Main outcomes The primary outcome is the time from initiation of supplementation (curcumin-piperine or placebo) to normalization of fever, respiratory rate, and blood oxygen saturation. The secondary outcomes are the mortality rate, length of stay in ICU, temperature, levels of blood oxygen saturation, ventilator dependency, respiratory rate, levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), levels of liver markers (ALT, AST, LDH), and levels of kidney function markers (BUN, Creatinine). Follow up All of the parameters will be assessed at baseline and end of the study (7 days intervention). In addition, the rate of mortality will be collected after 4 weeks (28 days’ mortality in the ICU, 4 weeks follow up). Randomisation Eligible patients will be randomly assigned to either the intervention group (Curcumin-piperine) or the control group (Placebo). Randomization sequences will be generated using an electronic table of random numbers to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the stratified block randomization method. Stratification was conducted according to sex (male and female), with a block size of four. The allocation sequences will be prepared by an independent statistician and will be kept inside sealed, opaque, and consecutively numbered envelopes. Participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. Blinding (masking) This study is a double-blind clinical trial (participants, investigators, nurses, and physicians). The curcumin-piperine and placebo supplements will be similar in the terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labeling, and packaging. All participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. Numbers to be randomised (sample size) The sample size is estimated at 60 participants, including 30 patients in the intervention group and 30 patients in the placebo group. Trial Status The protocol is Version 2, registered on May 13, 2021. Recruitment began May 20, 2021, and is anticipated to be completed by September 20, 2021. Trial registration This trial has been registered in Iranian Registry of Clinical Trials (IRCT) with the title of “Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU): a double-blind clinical trial study”. IRCT registration number is IRCT20121216011763N52. The registration date was May 13, 2021. Full Protocol The full protocol is attached as an additional file, accessible from the Trials website (File 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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Development of “Advancing People of Color in Clinical Trials Now!”: Web-Based Randomized Controlled Trial Protocol (Preprint)

10.2196/preprints.17589 ◽

2019 ◽

Author(s):

Alicia Chung ◽

Azizi Seixas ◽

Natasha Williams ◽

Yalini Senathirajah ◽

Rebecca Robbins ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Self Efficacy ◽

Intervention Group ◽

People Of Color ◽

Control Group ◽

Research Approach ◽

Web Based ◽

Culturally Tailored ◽

Clinical Trial Enrollment

BACKGROUND Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of “Advancing People of Color in Clinical Trials Now!” (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed <i>t</i> test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. CLINICALTRIAL ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17589

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The effect of letrozole versus artificial hormonal endometrial preparation on pregnancy outcome after frozen-thawed embryos transfer cycles: a randomized clinical trial

Reproductive Biology and Endocrinology ◽

10.1186/s12958-020-00675-z ◽

2020 ◽

Vol 18 (1) ◽

Author(s):

Azadeh Hosseini-Najarkolaei ◽

Ashraf Moini ◽

Ladan Kashani ◽

Maryam Farid Mojtahedi ◽

Elnaz Hosseini-Najarkolaee ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Current Evidence ◽

Control Group ◽

Human Menopausal Gonadotropin ◽

Widespread Application ◽

Link Type ◽

Endometrial Preparation

Abstract Background Considering that clinical trial studies are limited in polycystic ovary syndrome (PCOS) patients, and there is no consensus on an optimum endometrial preparation protocol for frozen embryo transfer (FET), the present study was designed as a randomized clinical trial to compare the reproductive outcomes following stimulated cycles with letrozole plus human menopausal gonadotropin (HMG) for endometrial preparation compared with routine AC-FET. Methods This randomized controlled trial was carried out on infertile PCOS patients who underwent IVF/ICSI and FET cycles in Arash Women’s Hospital affiliated to Tehran University of Medical Sciences between September 2018 and January 2020. PCOS diagnosis was based on the Rotterdam criteria. Eligible patients were randomly allocated into two groups: stimulated cycle with letrozole plus (HMG) (intervention group) and routine artificial hormonal endometrial preparation (control group). Results One hundred seventy-seven infertile patients were recruited for participation in the study. Of these, 57 women were excluded due to non-eligibility for entering the study, and a total of 120 patients were randomly assigned to two study groups. After follow up, the cycle outcomes of 57 patients in the intervention group and 59 patients in the control group were compared. The data analysis showed that the two groups did not have significant differences in fundamental and demographic characteristics. After the intervention, there were no significant differences in implantation rate, chemical, ectopic, and clinical pregnancy rates between groups. Moreover, the rates of miscarriage and ongoing pregnancy were similar between groups (P > 0.05). Conclusions We found similar pregnancy outcomes with two endometrial preparation methods. Noting that each treatment centre should select the most beneficial and cost-effective method with the least adverse effects for patients, letrozole preparations for FET could be incorporated into possible options; however, establishing this approach as first-line treatment is premature in light of current evidence, and future randomized clinical trials with larger sample sizes are required for widespread application. Trial registration The study was also registered in the Iranian Registry of Clinical Trials on March 20th, 2020. (IRCT20090526001952N12 at www.irct.ir, registered retrospectively).

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Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04706-3 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Omid Safa ◽

Mehdi Hassani-Azad ◽

Mehdi Farashahinejad ◽

Parivash Davoodian ◽

Habib Dadvand ◽

...

Keyword(s):

Clinical Trial ◽

Standard Treatment ◽

Clinical Symptoms ◽

Intervention Group ◽

Control Group ◽

Root Extract ◽

Open Label ◽

Natural Medicine ◽

Full Protocol ◽

Bandar Abbas

Abstract Objectives We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients with confirmed COVID-19 that are moderately ill. Trial design This is a single-center, open-label, randomized, clinical trial with parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants Both male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria. Inclusion criteria: 1. Confirmed diagnosis of SARS-CoV-2 infection (via polymerase chain reaction [PCR] and/or antibody test). 2. Presenting as moderate COVID-19 pneumonia (via chest computed tomography (CT) and/or X-ray) requiring hospitalization. 3. Hospitalized ≤48 hours. 4. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm. Exclusion criteria: 1. Underlying diseases, including chronic heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs. 4. Treatment with Investigational and antiviral therapy in a clinical study within one month before randomization. 5. History of allergy to Licorice. 6. Pregnancy and breastfeeding. Intervention and comparator Intervention group: The standard treatment regimen for COVID-19 along with a Licorice-based herbal preparation (D-Reglis ®, Irandarouk Pharmaceutical Company, Iran) at a dose of 760 mg three times a day for a period of seven days. Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol for a period of seven days. Main outcomes The recovery rate of clinical symptoms, including fever, dry cough, and tiredness, as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein, are evaluated as primary outcomes within seven days of randomization. Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization. Randomization An electronic table of random numbers will be used to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the simple randomization method. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group). Trial Status The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20200506047323N2”, https://www.irct.ir/trial/47990. The registration date is 31 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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Development of “Advancing People of Color in Clinical Trials Now!”: Web-Based Randomized Controlled Trial Protocol

JMIR Research Protocols ◽

10.2196/17589 ◽

2020 ◽

Vol 9 (7) ◽

pp. e17589

Author(s):

Alicia Chung ◽

Azizi Seixas ◽

Natasha Williams ◽

Yalini Senathirajah ◽

Rebecca Robbins ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Self Efficacy ◽

Intervention Group ◽

People Of Color ◽

Control Group ◽

Research Approach ◽

Web Based ◽

Culturally Tailored ◽

Clinical Trial Enrollment

Background Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of “Advancing People of Color in Clinical Trials Now!” (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. Objective This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. Methods ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. Results We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. Conclusions ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. Trial Registration ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401 International Registered Report Identifier (IRRID) DERR1-10.2196/17589

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Clinical Trials in Acute Stroke: Is it ethical to randomise patients to the placebo group?.

Stroke ◽

10.1161/str.32.suppl_1.371-d ◽

2001 ◽

Vol 32 (suppl_1) ◽

pp. 371-371

Author(s):

Joaquin Serena ◽

Mar Castellanos ◽

Yolanda Silva ◽

Teresa Osuna ◽

Francisco Alvarez ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Placebo Group ◽

Acute Stroke ◽

Infarct Volume ◽

Control Group ◽

Stroke Severity ◽

Stroke Subtype ◽

Related Factors ◽

Progressing Stroke

P178 The ethics of randomising a patient to the placebo group in acute stroke clinical trials has been called into question in one study as these patients may be deprived of routinely applied therapies. No other study has previously analysed this hypothesis. Objective: To compare the prognosis at day 90 of patients included in clinical trials of acute stroke and randomised to the placebo group with patients not included in any clinical trial. Material and Methods: 50 patients consecutively included in the placebo group (CLASS, ECASS-II, Trafermin, GAIN), and 50 patients not included in any clinical trial randomly selected from those sharing similar characteristics (age, sex, stroke severity and stroke subtype using the TOAST criteria) and hospitalised during the same period. Results: No differences were found in neurological attention delay, Canadian scale at admission, final infarct volume and length of hospital stay. The placebo group had a lower proportion of progressing stroke than the control group (14% vs. 25%). Infectious and cardiovascular complications were more frequent in the placebo group (12% vs. 6% and 15% vs. 8%, respectively). However, the placebo group displayed a more favourable outcome at day 90 (Figure). Conclusions: Inclusion in a placebo group in acute stroke clinical trials results in a significant benefit. This advantage may be explained by a more active intervention over progressing stroke, resulting from a higher rate of detection and control of the related factors.

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Piptadenia gonoacantha-based natural dermocosmetic: a clinical trial

Ciência e Natura ◽

10.5902/2179460x43676 ◽

2021 ◽

Vol 43 ◽

pp. e1-43676

Author(s):

Luciano Côrtes Paiva ◽

Karen Vieira da Silva ◽

Gabriel Feu Guarçoni de Almeida ◽

Eliana Amaro de Carvalho Caldeira ◽

Carlos Eduardo Soares Gazzinelli Cruz ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Placebo Group ◽

Intervention Group ◽

Clinical Phase ◽

Phase Ii Clinical Trials ◽

Phase Study ◽

Significant Difference ◽

Before And After ◽

Group A

The use of phytotherapy expands the possibility of therapeutic resources for the population, often offering reduced costs when compared to the pharmaceutical industry. In this perspective, the JACBIO® dermocosmetic ointment revealed, in non-clinical trials, its antibacterial and healing potential, with a great stimulating effect in increasing the production of images. This work aimed to carry out the clinical phase study on dermal toxicity, in serious humans, by applying JACBIO®, based on extracts from the leaves of Piptadenia gonoacantha (Pau Jacaré). The phase I randomized clinical trial was carried out with 28 clinically healthy patients at a public university in Minas Gerais, with no period from August to December 2018. The toxicological trial was developed with the intervention group that received a JACBIO® dermatological ointment and the Placebo group. From the experimental protocol, participants were followed for four weeks. An analysis between the ointment and placebo groups, without reference to anticholinergic and cardiovascular events, showed no statistically significant difference. Likewise, there was no difference in laboratory results performed before and after treatment, both for the placebo group and for the intervention group. A low toxicity of the product indicates that this adjustment is safe and serves as a basis for phase II clinical trials in patients with lesions.

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New therapy for chemotherapy-induced hepatic failure in leukemia; a randomized double-blind clinical trial study

Immunopathologia Persa ◽

10.34172/ipp.2021.16 ◽

2020 ◽

Vol 7 (2) ◽

pp. e16-e16

Author(s):

Farid Ghazizadeh ◽

Mehran Noroozi ◽

Parvaneh Shadara ◽

Javad Rasouli ◽

Sasan Hejazi

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Lymphoblastic Leukemia ◽

Intervention Group ◽

Serum Levels ◽

Control Group ◽

Milk Thistle ◽

Double Blind Study ◽

Double Blind ◽

Effective Role

Introduction: Hepatotoxicity is usual toxicity after chemotherapy in acute lymphoblastic leukemia (ALL) patients. Conventional treatment methods such as supportive care did not have an effective role in the improvement of hepatotoxicity. Objectives: In this study clinical efficacy of milk thistle in contrast with placebo was compared in leukemia patients with chemotherapy-induced hepatotoxicity. Patients and Methods: In this double-blind study, 93 ALL patients with chemotherapy-induced hepatotoxicity were randomized to a clinical trial with milk thistle or placebo. Liver enzymes level evaluated during 70 days. We divided patients randomly into two groups. Milk thistle at dosage of 7 mg/kg daily was prescribed in the intervention group while in the control group, placebo pills similar to milk thistle in shape and color were prescribed daily. Results: At day 35 and day 70 of the study, in the milk thistle arm ALT and AST mean serum levels were lower than the placebo group (P<0.001). In the milk thistle group there was a significant reduction in mean of AST and ALT during the first 35 days in patients who were taking livergol in comparison to next 35 days that patients stopped taking it. Children’s age was between 3-15 years. Conclusion: Based on our results, milk thistle improves liver function in chemotherapy-induced hepatotoxicity and there was no need for dose reduction or discontinuation of chemotherapy. Future clinical trials should be conducted to explore longtime effect of livergol in leukemia patients and to determine if there is any need for prophylactic administration of antioxidants. Trial Registration: This clinical trial has been approved by the Iranian Registry of Clinical Trials at 2018-02-14 (identifier: IRCT20170821035831N2; http://en.irct.ir/trial/26957).

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Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial

Middle East Journal of Digestive Diseases ◽

10.15171/mejdd.2020.160 ◽

2019 ◽

Vol 12 (1) ◽

pp. 27-33 ◽

Cited By ~ 2

Author(s):

Taghi Amiriani ◽

Niloofar Rajabli ◽

Maryam Faghani ◽

Sima Besharat ◽

Gholamreza Roshandel ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Trial ◽

Placebo Group ◽

Disease Severity ◽

Activity Index ◽

Intervention Group ◽

Response To Treatment ◽

Control Group ◽

Double Blind ◽

Double Blind Clinical Trial

BACKGROUND Inflammatory bowel diseases are managed by different methods, which may not be well tolerated because of their side effects. Recently, pro-prebiotics are considered as a supplementary treatment in gastrointestinal diseases. In this study, the effect of Lactocare® (ZistTakhmir Company) was investigated on the disease severity in mild to moderate ulcerative colitis. METHODS In this randomized, double-blind clinical trial (Iranian Registry of Clinical Trials number: IRCT201407271264N5), 60 patients with mild to moderate ulcerative colitis were included. An 8-week trial was carried out comparing Lactocare® as a supplement with standard therapy against placebo. Simple Clinical Colitis Activity Index (SCCAI) was measured at baseline and after 8 weeks. Statistical analysis was performed using paired ttest to assess the temporal changes (before and after the treatment) in the mean of SCCAI in each group. Chi-square test was used to compare the response rates. Odds ratios (OR) and the 95% confidence intervals (95%CI) were also calculated. p values of less than 0.05 were considered significant. RESULTS A significant decreased mean SCCAI was seen in the intervention group (4.56 ± 2.56) vs. placebo group (6.54 ± 2.47) (p < 0.05). Response to treatment was seen in 64.3% of the treatment group vs. 47% in the placebo group (p = 0.18). Response to treatment was observed in 90.9% of patients with ulcerative colitis for more than 5 years compared with 44.4% of the control group (p = 0.01). CONCLUSION Regarding the effectiveness of pre-probiotics in mitigating symptoms in patients with ulcerative colitis, it could be suggested to try pre-probiotics in the standard treatment particularly in those with more than five years ofthe disease.

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