Piptadenia gonoacantha-based natural dermocosmetic: a clinical trial

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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Comparing the Efficacy of Topical Metformin and Placebo in the Treatment of Melasma: A Randomized, Double-blind, Clinical Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v30i430276 ◽

2019 ◽

pp. 1-8

Author(s):

Mohammad Ali Mapar ◽

Ali Asghar Hemmati ◽

Ghazal Namdari

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Double Blind ◽

Laboratory Findings ◽

Double Blind Clinical Trial ◽

Metformin Group ◽

Significant Difference ◽

Before And After ◽

P 16 ◽

The Mean

Introduction: Generally affecting women, melasma is the acquired disorder of hyperpigmentation, and researches are still ongoing to find an effective, fast, and low-side-effect drug treating this disease. The present study is aimed at comparing the efficacy of topical metformin and placebo in the treatment of melasma. Methods: Sixty patients with melasma were treated in placebo and topical metformin recipient groups in a double-blind clinical trial. In addition to the demographic and laboratory findings of patients before and after the intervention, the MASI Score of patients in weeks 0, 4, 8, and 12 of the study and then one month after the study were analyzed using SPSS version 20 software. Results: The mean age of the studied patients was 35.25 ± 7.11 years. No significant difference was observed between the phenotypes (P= .49) and the type of melasma (P= .63) in the two groups. The mean MASI score of patients at the time of being included in the study in the placebo group was 10.47 ± 3.08; and in the metformin group, it was 11.93 ± 4.64 (P = .16). Compared to the beginning of the study, the MASI scores were significantly decreased in both groups of placebo (P = .00) and metformin (P = .00) one month after the end of the study; nevertheless, no statistically significant difference was observed between the MASI Scores of two groups in any of the study periods (P > .05). Conclusion: The results of the present study showed that metformin cream significantly declines the patients’ MASI score and does not have any effect on patients’ laboratory markers. Of course, no significant difference was observed between the MASI scores of the patients receiving metformin and the placebo group; however, the MASI score decrease trend continued until the 12th week; while in the placebo group, no significant decrease was seen after eight weeks.

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Effects of Levothyroxine Treatment on Lipid Profile in Subclinical Hypothyroidism: A Randomized Clinical Trial

Galen Medical Journal ◽

10.31661/gmj.v4i2.214 ◽

2015 ◽

Vol 4 (2) ◽

pp. 72-77

Author(s):

Karoon Shahebrahimi ◽

Rozita Naseri ◽

Tahereh Sadat Kalantarian ◽

Mehrali Rahimi ◽

Farid Najafi ◽

...

Keyword(s):

Clinical Trial ◽

Lipid Profile ◽

Subclinical Hypothyroidism ◽

Serum Lipids ◽

Intervention Group ◽

Control Group ◽

Significant Difference ◽

Before And After ◽

Clinically Significant ◽

Levothyroxine Treatment

Background: Studies demonstrated controversial results on subclinical hypothyroidism (SCH) regarding lipid profile alteration with or without Levothyroxine treatment. The purpose of this study is to investigate the effects of Levothyroxine on serum lipids in SCH. Materials and Methods: One hundred patients with SCH referred to Taleghani hospital in Kermanshah were recruited and randomly assigned into the intervention or the control group. Patients in intervention group received Levothyroxine 50-75 micrograms for three months. Patients in control group received the same placebo with the same dose and duration. Lipid profile was measured before and after the trial and the changes were compared between groups. (IRCT code: 138903244179N1). Results: Triglyceride, Total Cholesterol, LDL, HDL and Lipoprotein-A were measured before and after treatment. None of the factors showed significant difference either between or within groups, before and after the treatment (P<0.05). Conclusion: Treating with Levothyroxine does not have any clinically significant impact on lipid profile in SCH patients which indicates that we should not expect SCH patients to use Levothyroxine solely for lipid profile alternation, except those with other clinical indications for treatment.[GMJ.2015;4(2):72-77]

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Laser Acupuncture for Relieving Nausea and Vomiting in Pediatric Patients Undergoing Chemotherapy: A Single-Blind Randomized Clinical Trial

Journal of Pediatric Oncology Nursing ◽

10.1177/1043454218810140 ◽

2018 ◽

Vol 36 (1) ◽

pp. 44-54 ◽

Cited By ~ 2

Author(s):

Cristiane da Silva Varejão ◽

Fátima H. do Espírito Santo

Keyword(s):

Placebo Group ◽

Children And Adolescents ◽

Intervention Group ◽

Nausea And Vomiting ◽

Laser Acupuncture ◽

Placebo Acupuncture ◽

Significant Difference ◽

Group A ◽

The City ◽

Single Blind

Nausea and vomiting are frequent side effects associated with chemotherapy treatments. The aim of this study was to evaluate the efficacy of laser acupuncture in relieving nausea and vomiting in children and adolescents undergoing laser treatment. This is an experimental, randomized, single-blind study. The research was carried out at the INCA (Instituto Nacional de Câncer), a reference institution in the control and treatment of cancer, located in the city of Rio de Janeiro, Brazil. The research project was approved by the INCA Research and Ethics Committee under Registration No. 164/14 and CAAE 3374551.0.3001.5274. Children and adolescents between the ages of 6 and 17 years who were undergoing chemotherapy with drugs of high and medium degrees of emetogenic toxicity were selected. The participants were divided into two groups, A and B. In A, the active acupuncture was applied, and in B, the placebo acupuncture was applied. Analysis of the data indicated that there was significant relief from nausea in the intervention group when compared with the placebo group. A decrease in the number of episodes of vomiting on the second and third days of chemotherapy was also observed. On Days 1, 4, and 5, there was no significant difference in the number of episodes of vomiting in the intervention group as compared with the placebo group. The study concluded that laser acupuncture was effective in relieving nausea within 5 days of chemotherapy and in reducing the number of episodes of vomiting on Days 2 and 3 after chemotherapy.

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The Effect of Oral Administration of Pistacia Atlantica Kurdica Gum on the Eradication of Helicobacter Pylori in Patients with Dyspepsia: A Randomized Clinical Trial

Global Journal of Health Science ◽

10.5539/gjhs.v9n2p256 ◽

2016 ◽

Vol 9 (2) ◽

pp. 256 ◽

Cited By ~ 1

Author(s):

Hamidollah Afrasiabian ◽

Mohammad Hadi Imanieh ◽

Mohammad Ali Nejati ◽

Alireza Salehi

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Demographic Situation ◽

Significant Difference ◽

Before And After ◽

Group A ◽

H Pylori ◽

Group B ◽

Group D ◽

Common Infections

H. pylori infection is one of the most common infections in the world so that the aim of this study was to evaluate the antimicrobial P. Atlantica Kurdica gum in the eradication of H. pylori. This study is a randomized clinical trial; Patients with positive Urea Breath Test and symptoms of dyspepsia were entered. Patients were randomly divided into four groups. Group A: three drugs including 500 mg of Amoxicillin twice a day (bd), Clarithromycin 500 mg bd and Omeprazole 20 mg (bd) and Group B: Group A drugs plus the capsule containing 1 g of powdered P. Atlantica Kurdica gum (bd). In Group C: the capsule containing 1 g of powdered P. Atlantica Kurdica gum (bd) and Group D: this group took placebo-containing capsule (bd) for 14 days respectively. Dyspeptic symptoms before and after healing period and the UBT results two days before the start of treatment and 30 days after the completion were compared in 4 groups. Patients were not statistically significant difference from each other in the four groups regarding the demographic situation. Moreover, H. pylori eradication rate was 19/24 in Group A, 18/24 in Group B, 10/23 in Group C and 2/24 in Group D. Relieving symptoms of dyspepsia in Groups B and C were significantly higher than in Group D (P=0.025 and p=0.006 respectively). P. Atlantica Kurdica significantly led to the treatment of dyspepsia symptoms and H. pylori eradication.

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Effect of Recitation of Tawassul Prayer on Anxiety and Physiological Parameters of Patients with Myocardial Infarction Admitted to Coronary Care Unit: A Randomized Clinical Trial

10.32592/ircmj.2021.23.8.785 ◽

2021 ◽

Keyword(s):

Myocardial Infarction ◽

Clinical Trial ◽

Respiratory Rate ◽

Intervention Group ◽

Depression Scale ◽

Physiological Parameters ◽

Human Needs ◽

Significant Difference ◽

Before And After ◽

The Mean

Background and Aims: Anxiety following acute myocardial infarction is a particularly important issue. Prayer is one of the basic human needs that is related to mental health. In this regard, this study aimed to determine the effect of recitation of Tawassul prayer on anxiety and physiological parameters of patients with myocardial infarction. Materials and Methods: This clinical trial was performed on 80 patients for 6 months from August 2017 to March 2018. They were selected by the targeted sampling method and randomly assigned to two groups with gender and age block randomization. The subjects were asked to complete the anxiety subscale of the Hospital Anxiety and Depression Scale. Physiologic parameters were measured and participants in the intervention group listened to the recitation of the Tawassul Prayer with headphones. Results: In the experimental group, the mean of anxiety scores before and after intervention were 11.17±3.06 and 5.81±3.16, respectively, which had a significant difference (P<0.001). There was a significant difference between the two groups in terms of the mean scores of anxiety before and after intervention (P<0.001) and the respiratory rate before and after intervention (P=0.025). Conclusion: Prayer affected the level of anxiety and respiratory rate. This prayer is useful for reducing anxiety and improving the respiratory rate in patients with myocardial infarction.

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Metformin as a new option in the medical management of breast fibroadenoma; a randomized clinical trial

BMC Endocrine Disorders ◽

10.1186/s12902-021-00824-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sadaf Alipour ◽

Mahboubeh Abedi ◽

Azin Saberi ◽

Arezoo Maleki-Hajiagha ◽

Firoozeh Faiz ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Treatment Group ◽

Randomized Clinical Trial ◽

Favorable Effect ◽

Female Sex Hormones ◽

Significant Difference ◽

Before And After ◽

The Masses ◽

Higher Doses

Abstract Background Fibroadenoma (FA) is the most common benign solid breast mass in women, with no definite method of management. Because fibroadenoma is dependent on female sex hormones and comprises hypertrophic changes at cellular levels, we investigated the effects of metformin (MF), a safe hypoglycemic agent with anti-estrogenic and anti-proliferative properties, in the management of fibroadenoma. Methods In this randomized clinical trial study, eligible women with fibroadenomas were assigned randomly to the metformin (1000 mg daily for six months) or the placebo group. Breast physical and ultrasound exam was performed before and after the intervention, and the changes in the size of fibroadenomas were compared in the two groups. Results Overall, 83 patients in the treatment, and 92 in the placebo group completed the study. A statistically significant difference in changing size between the two groups was observed only in the smallest mass. In the largest FAs, the rate of size reduction was higher in the treatment group (60.2 % vs. 43.5 %); while a higher rate of enlargement was observed in the placebo group (38 % vs. 20.5 %). In the smallest FAs, the rate of the masses that got smaller or remained stable was about 90 % in the treatment group and 50 % in the placebo group. We categorized size changes of FAs into < 20 % enlargement and ≥ 20 % enlargement. The odds ratio (OR) for an elargemnt less than 20% was 1.48 (95 % CI = 1.10–1.99) in the treatment group in comparison with the placebo group; the odds for an enlargement less than 20% was higher in women with multiples fibroadenomas (OR = 4.67, 95 % CI: 1.34–16.28). In our study, no serious adverse effect was recorded, and the medicine was well-tolerated by all users. Conclusions This is the first study that evaluates the effect of MF on the management of fibroadenoma, and the results suggest a favorable effect. Larger studies using higher doses of MF and including a separate design for patients with single or multiple FAs are suggested in order to confirm this effect. Trial registration This trial (IRCT20100706004329N7) was retrospectively registered on 2018-10-07.

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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

Trials ◽

10.1186/s13063-020-04824-y ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Mehdi Hassaniazad ◽

Behnaz Rahnama Inchehsablagh ◽

Hossein Kamali ◽

Abdolali Tousi ◽

Ebrahim Eftekhar ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Placebo Group ◽

Immune Responses ◽

Intervention Group ◽

Control Group ◽

Chronic Obstructive ◽

Time Points ◽

History Of ◽

Full Protocol

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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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

BMC Endocrine Disorders ◽

10.1186/s12902-021-00731-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Zahra Barati ◽

Mina Iravani ◽

Majid Karandish ◽

Mohammad Hosein Haghighizadeh ◽

Sara Masihi

Keyword(s):

Clinical Trial ◽

Blood Glucose ◽

Gestational Diabetes ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Standard Diet ◽

Oat Bran ◽

Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

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The effects of whole grain intake on anthropometric measures in overweight and obese children: a crossover randomised clinical trial

British Journal Of Nutrition ◽

10.1017/s000711452100026x ◽

2021 ◽

pp. 1-7

Author(s):

Parisa Hajihashemi ◽

Leila Azadbakht ◽

Mahin Hashemipour ◽

Roya Kelishadi ◽

Parvane Saneei ◽

...

Keyword(s):

Clinical Trial ◽

Waist Circumference ◽

Intervention Group ◽

Randomised Clinical Trial ◽

Slight Reduction ◽

Whole Grain ◽

Obese Children ◽

Anthropometric Measures ◽

Before And After ◽

Grain Foods

Abstract Whole-grain foods have been reported to affect body weight and satiety. However, we are aware of no study in this regard among children. The present study aimed to determine the effects of whole grain consumption on anthropometric measures in overweight or obese children. In this randomised crossover clinical trial, forty-four overweight or obese girls participated. After a 2-week run-in period, subjects were randomly assigned to either intervention (n 44) or non-intervention (n 44) groups. Subjects in the intervention group were given a list of whole-grain foods and were asked to obtain half of their grain servings from these foods each day for 6 weeks. Individuals in the non-intervention group were asked not to consume any of these foods. A 4-week washout period was applied. Then, participants were crossed over to the alternate arm. The measurements were done before and after each phase. Mean age, weight and BMI of participants were 11·2 (sd 1·49) years, 51·2 (sd 10·2) kg and 23·5 (sd 2·5) kg/m2, respectively. Despite the slight reduction in weight and BMI, there were no significant differences in changes in these anthropometric measures. We found a significant effect of whole grain intake on waist circumference (−2·7 v. 0·3 cm, P = 0·04). No significant changes in hip circumference were observed. Changes in the prevalence of overweight, obesity and abdominal obesity were not significantly different. This study indicated a beneficial effect of whole-grain foods on waist circumference in overweight children; however, these foods did not influence weight and BMI.

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