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

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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The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

10.21203/rs.3.rs-40899/v3 ◽

2020 ◽

Author(s):

Naser Gharebaghi ◽

Rahim Nejadrahim ◽

Seyed Jalil Mousavi ◽

Seyyed-Reza Sadat-Ebrahimi ◽

Reza Hajizadeh

Keyword(s):

Clinical Trial ◽

Mortality Rate ◽

Hospital Mortality ◽

Intravenous Immunoglobulin ◽

Initial Treatment ◽

Control Group ◽

Double Blind ◽

Reduce Mortality Rate ◽

Double Blind Clinical Trial ◽

Laboratory Test Results

Abstract Background: Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.Methods: This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for three days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded.Results: Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042).Conclusions: Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.Trial registration: A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

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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 Nebulized Eucalyptus for Preventing Ventilator-Associated Pneumonia in Patients under Mechanical Ventilation: A Randomized Double Blind Clinical Trial

10.21203/rs.1.15/v1 ◽

2018 ◽

Author(s):

HasanAli Karimpour ◽

Behzad Hematpour ◽

Saeed Mohammadi ◽

Javad Aminisaman ◽

Maryam Mirzaei ◽

...

Keyword(s):

Clinical Trial ◽

Intensive Care Unit ◽

Intensive Care ◽

Intervention Group ◽

Control Group ◽

Pulmonary Infections ◽

Double Blind ◽

Double Blind Clinical Trial ◽

And Control ◽

And Staphylococcus Aureus

Abstract Background: Pneumonia caused by the ventilator is the most common acquired infection in the intensive care unit, which increases the morbidity and mortality of the patients. Eucalyptus plant has antiseptic properties. Therefore, the present study investigates the effect of eucalyptus incense on prevention of pneumonia in patients with endotracheal tube in the intensive care unit. Methods: This clinical trial study was performed on 100 patients under ventilation in two intervention and control groups in Imam Reza Hospital, Kermanshah, Iran in 2018. The patients in the intervention group, Eucalyptus solution 2% and in the control group received 10 cc distilled water as an inhaler three times a day. The results of the two groups were compared to the incidence of pulmonary infections based on CPIS criteria and compared with SPSS version 19 software. Results: The incidence of late pneumonia was significantly lower in the intervention group (P=0.02). The onset of pneumonia significantly later in the intervention group than the control group (P=0.01). The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P=0.02) (P=0.04) (P=0.01). Conclusion: The results of this study showed that eucalyptus inhalation is effective in reducing the incidence of pulmonary infection in patients under ventilation. It is recommended that these products be used to prevent pulmonary infections in these patients.

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Effect of Fenticonazole in Vaginal Candidiasis: A Double-Blind Clinical Trial versus Clotrimazole

Journal of International Medical Research ◽

10.1177/030006058601400604 ◽

1986 ◽

Vol 14 (6) ◽

pp. 306-310 ◽

Cited By ~ 11

Author(s):

Earl Brewster ◽

Piero Monici Preti ◽

Ralf Ruffmann ◽

John Studd

Keyword(s):

Clinical Trial ◽

Previous History ◽

Vaginal Candidiasis ◽

Control Group ◽

Apparent Difference ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Antimycotic Activity ◽

Objective Evidence ◽

History Of

Fenticonazole is an imidazole derivative which possesses a broad spectrum antimycotic activity, including activity against Candida albicans. Its therapeutic activity and tolerability have been evaluated, in a double-blind clinical trial versus clotrimazole, in 54 patients affected by mycologically confirmed symptomatic vaginal candidiasis. Both drugs were administered intravaginally as a cream once a day for 7 days. Assessment was by laboratory mycological investigations and symptomatic evaluation. Patients ‘cured’ at the end of the trial were re-evaluated after 4–6 weeks for possible relapses. Both treatments resulted in a progressive, statistically significant reduction in vaginal symptoms (itching and discharge) and in elimination of Candida in more than 95% of patients. When ‘cured’ patients were reassessed 4–6 weeks after therapy, relapses occurred in four patients after fenticonazole treatment, but in none following clotrimazole treatment. This apparent difference between treatments is far from being statistically significant and, therefore, may have been a chance occurrence. It should also be noted that patients from the fenticonazole group had a previous history of significantly more frequent episodes of candidiasis suggesting that they may have been at greater risk of re-infection than patients from the control group. The tolerance of both treatments was excellent since no local or systemic signs or symptoms of toxicity were reported. An equally high efficacy and safety for both drugs in the elimination of symptoms and objective evidence of vaginal candidiasis is indicated.

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The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial

BMC Infectious Diseases ◽

10.1186/s12879-020-05507-4 ◽

2020 ◽

Vol 20 (1) ◽

Cited By ~ 5

Author(s):

Naser Gharebaghi ◽

Rahim Nejadrahim ◽

Seyed Jalil Mousavi ◽

Seyyed-Reza Sadat-Ebrahimi ◽

Reza Hajizadeh

Keyword(s):

Clinical Trial ◽

Mortality Rate ◽

Hospital Mortality ◽

Intravenous Immunoglobulin ◽

Initial Treatment ◽

Control Group ◽

Double Blind ◽

Link Type ◽

Double Blind Clinical Trial ◽

Laboratory Test Results

Abstract Background Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection. Methods This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for 3 days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded. Results Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.025). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042). Conclusions Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment. Trial registration A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

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Bone Texture Fractal Dimension Analysis of Ultrasound-Treated Bone around Implant Site: A Double-Blind Clinical Trial

International Journal of Dentistry ◽

10.1155/2018/2672659 ◽

2018 ◽

Vol 2018 ◽

pp. 1-10 ◽

Cited By ~ 4

Author(s):

Elaf Akram Abdulhameed ◽

Natheer Hashim Al-Rawi ◽

Asmaa Tahseen Uthman ◽

Ab Rani Samsudin

Keyword(s):

Clinical Trial ◽

Fractal Dimension ◽

Intervention Group ◽

High Specificity ◽

Control Group ◽

Implant Stability ◽

Double Blind ◽

Cutoff Value ◽

Double Blind Clinical Trial ◽

Standard Implant

Objectives. To evaluate the efficacy of bone texture fractal dimension (FD) analysis method in predicting implant stability from intraoral periapical radiographs using two implant protocols. Materials and Methods. A double-blind clinical trial was conducted on 22 subjects who needed dental implants. The participants were randomized into two groups, the control group with standard implant protocol treatment and the intervention group with added low-intensity power ultrasound treatment (LIPUS) besides the standard implant protocol. The FD values of bone density were carried out on the mesial and distal sides of the implant on digital intraoral radiographs using the box-counting method. Both resonance frequency (RF) and fractal dimension (FD) were assessed in three time intervals: after surgery and before and after loading. Results. FD on both the mesial and distal sides serve as very good-to-excellent tests with high validity (ROC area exceeding 0.8) in predicting high implant stability (ISQ ≥ 70). The mesial side measurements were consistently better than the distal side among the intervention groups. The optimum cutoff value for the FD-mesial side that predicts a highly stable implant (ISQ ≥ 70) is ≥1.505. At this optimum cutoff value, the mesial side FD is associated with a perfect sensitivity (100%) and fairly high specificity (86.5%). Conclusion. The FD analysis could be recommended as an adjunctive quantitative method in prediction of the implant stability with very high sensitivity and specificity. This trial is registered with ISRCTN72648040.

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Therapeutic Effects of Ursodeoxycholic Acid in Neonatal Indirect Hyperbilirubinemia; a Randomized Double-Blind Clinical Trial

Archives of Anesthesia and Critical Care ◽

10.18502/aacc.v5i3.1211 ◽

2019 ◽

Author(s):

Iraj Shahramian ◽

Kaveh Tabrizian ◽

Pouya Ostadrahimi ◽

Mahdi Afshari ◽

Mahdieh Soleymanifar ◽

...

Keyword(s):

Clinical Trial ◽

Ursodeoxycholic Acid ◽

Total Bilirubin ◽

Intervention Group ◽

Total Bilirubin Level ◽

Direct Bilirubin ◽

Therapeutic Effects ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Double Blinded

Background: Ursodeoxycholic acid (UDCA) is a safe drug used in the treatment of cholestatic liver disorders in children. The aim of this study was to investigate the synergistic effect of UDCA in combination with phototherapy in treating indirect neonatal hyperbilirubinemia. Methods: Present double-blinded, randomized clinical trial was conducted among neonates with jaundice who were under treatment with phototherapy in the neonatal ward affiliated with the Zabol University of Medical Sciences in 2017. The patients (200 neonates) were randomly divided into intervention (phototherapy+ UDCA) and control (phototherapy alone) groups. The intervention group received 15 mg/kg UDCA daily. Results: Total bilirubin levels at birth, 24, 48, and 72 hours after therapy were 16.89± 2.49, 14.28± 2.05, 11.62± 2.46, and 10.26± 1.92 mg/dl in controls and 15.79± 2.18, 12.77± 1.86, 10.08± 1.66, and 8.94± 1.38 mg/dl in intervention group respectively (P< 0.001). The ratio of neonates with total bilirubin< 10 mg/dl were 28% and 55% after 48 hours, and 64% and 90% after 72 hours of therapy initiation in phototherapy alone and phototherapy+ UDCA groups respectively (P< 0.001). The mean reduction of direct bilirubin was not significantly different between the groups. Conclusion: UDCA was effective in accelerating reduction of total bilirubin level in neonates with unconjugated hyperbilirubinemia under phototherapy but had no effect on direct bilirubin levels.

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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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The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

10.21203/rs.3.rs-40899/v2 ◽

2020 ◽

Author(s):

Naser Gharebaghi ◽

Rahim Nejadrahim ◽

Seyed Jalil Mousavi ◽

Seyyed-Reza Sadat-Ebrahimi ◽

Reza Hajizadeh

Keyword(s):

Clinical Trial ◽

Mortality Rate ◽

Hospital Mortality ◽

Intravenous Immunoglobulin ◽

Initial Treatment ◽

Control Group ◽

Double Blind ◽

Reduce Mortality Rate ◽

Double Blind Clinical Trial ◽

Laboratory Test Results

Abstract Background: Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.Methods: This study was conducted as a randomised placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for three days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded. Results: Among the total subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042).Conclusions: Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.Trial registration: A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

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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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