Effect of curcumin-piperine supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
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Protocol summary
Determination of the effect of curcumin-piperine supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus(COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
Determination of the effect of curcumin-piperine supplementation on disease duration, severity, and clinical signs and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
Determination of the effect of curcumin-piperine supplementation on disease duration, severity, and clinical signs, and inflammatory factors in patients with coronavirus(COVIDcoronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
This is a randomized, placebo-controlled, double-blind parallel-group clinical trial. one hundred participants will randomly allocated to receive curcumin-piperine supplement per day (n = 50) or placebo (n = 50).
This is a randomized, placebo-controlled, double-blind parallel-group clinical trial. One hundred participants will be randomly allocated to receive curcumin-piperine supplement per day (25 inpatients and 25 outpatients) or placebo (25 inpatients and 25 outpatients).
This is a randomized, placebo-controlled, double-blind parallel-group clinical trial. oneOne hundred participants will be randomly allocated to receive curcumin-piperine supplement per day (n = 5025 inpatients and 25 outpatients) or placebo (n = 5025 inpatients and 25 outpatients).
این مطالعه به صورت یک کارآزمایی بالینی دارای گروه کنترل و تصادفی شده موازی دو سو کور می باشد، که در آن100 فرد مبتلا به کرونا ویروس به دو گروه دریافت کننده مکمل کورکومین-پیپرین(50 نفر) و دارونما (50نفر) تقسیم خواهند شد.
این مطالعه به صورت یک کارآزمایی بالینی دارای گروه کنترل و تصادفی شده موازی دو سو کور می باشد، که در آن 100 فرد مبتلا به کرونا ویروس به دو گروه دریافت کننده مکمل کورکومین-پیپرین (25 بیمار بستری و 25 بیمار سرپایی) و دارونما (25 بیمار بستری و 25 بیمار سرپایی) تقسیم خواهند شد.
این مطالعه به صورت یک کارآزمایی بالینی دارای گروه کنترل و تصادفی شده موازی دو سو کور می باشد، که در آن100آن 100 فرد مبتلا به کرونا ویروس به دو گروه دریافت کننده مکمل کورکومین-پیپرین(50 نفرپیپرین (25 بیمار بستری و 25 بیمار سرپایی) و دارونما (50نفر25 بیمار بستری و 25 بیمار سرپایی) تقسیم خواهند شد.
In this study, patients with coronavirus will recruited from hospitals of Isfahan University of Medical Sciences. Subjects will stratified according to gender. Random assignment will done by the use of table of random numbers. The enrolling participants, and assigning participants to the groups will carried out by a relevant specialist.The curcumin-piperine supplement and its placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
In this study, patients with coronavirus will be recruited from hospitals of Isfahan University of Medical Sciences. Subjects will be stratified according to gender. Random assignment will be done by the use of a table of random numbers. The enrolling participants, and assigning participants to the groups will be carried out by a relevant specialist.The curcumin-piperine supplement and its placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
In this study, patients with coronavirus will be recruited from hospitals of Isfahan University of Medical Sciences. Subjects will be stratified according to gender. Random assignment will be done by the use of a table of random numbers. The enrolling participants, and assigning participants to the groups will be carried out by a relevant specialist.The curcumin-piperine supplement and its placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
Inclusion criteria: Tendency to participate in the study; People aged 18-65 years; Diagnosis of Covid-19 based on clinical findings and imaging findings (Chest X Ray), CT scan or PCR Exclusion criteria: Age less than 20 and more than 75 years;Taking warfarin; Sensitivity to plant products such as turmeric and pepper
Inclusion criteria: Tendency to participate in the study; People aged 18-65 years; Diagnosis of Covid-19 based on the PCR test.
Exclusion criteria: Age less than 20 and more than 75 years; Taking warfarin; Sensitivity to herbal products such as turmeric and pepper
Inclusion criteria: Tendency to participate in the study; People aged 18-65 years; Diagnosis of Covid-19 based on clinical findings and imaging findings (Chest X Ray), CT scan orthe PCR test. Exclusion criteria: Age less than 20 and more than 75 years;Taking warfarin; Sensitivity to plantherbal products such as turmeric and pepper
Individuals will randomly assigned to two groups to receive 1000 mg/day curcumin-piperine supplement or placebo for 12 weeks.
Individuals will be randomly assigned to two groups to receive the curcumin-piperine supplement (1000 mg/day of curcumin and 10 mg/day of piperine) or placebo (1010 mg of maltodextrin) for 2 weeks.
Individuals will be randomly assigned to two groups to receive 1000 mg/daythe curcumin-piperine supplement (1000 mg/day of curcumin and 10 mg/day of piperine) or placebo (1010 mg of maltodextrin) for 122 weeks.
افراد به طور تصادفی به دو گروه دریافت کننده مکمل کورکومین-پیپرین به میزان 1000 میلی گرم در روز و دارونما، به مدت 12 هفته تقسیم خواهند گردید.
افراد به طور تصادفی به دو گروه دریافت کننده مکمل کورکومین-پیپرین ( 1000 میلی گرم در روز کورکومین و 10 میلی گرم در روز پیپرین) و دارونما (1010میلی گرم در روز مالتودکسترین) به مدت 2 هفته تخصیص خواهند یافت.
افراد به طور تصادفی به دو گروه دریافت کننده مکمل کورکومین-پیپرین به میزان( 1000 میلی گرم در روز کورکومین و 10 میلی گرم در روز پیپرین) و دارونما، (1010میلی گرم در روز مالتودکسترین) به مدت 122 هفته تقسیمتخصیص خواهند گردیدیافت.
General information
2020-06-04, 1399/03/15
2021-04-19, 1400/01/30
2020-062021-04-19 00:00:00
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Correction of typos and updating of the sampling period
Correction of typos and updating of the sampling period
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اصلاح اشتباهات تایپی و بروزرسانی مدت نمونه گیری
اصلاح اشتباهات تایپی و بروزرسانی مدت نمونه گیری
Effect of curcumin-piperine in patients with coronavirus(COVID-19)
Effect of curcumin-piperine in patients with coronavirus (COVID-19)
Effect of curcumin-piperine in patients with coronavirus(COVIDcoronavirus (COVID-19)
Effect of curcumin-piperine supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus(COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
Effect of curcumin-piperine supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
Effect of curcumin-piperine supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus(COVIDcoronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
Tendency to participate in the study
People aged 18-65 years
Diagnosis of Covid-19 based on clinical findings and imaging findings (Chest X Ray), CT scan or PCR
Tendency to participate in the study
People aged 18-65 years
Diagnosis of Covid-19 based on the PCR test
Tendency to participate in the study People aged 18-65 years Diagnosis of Covid-19 based on clinical findings and imaging findings (Chest X Ray), CT scan orthe PCR test
تمایل به شرکت در مطالعه
سن 20-75 سال
تشخیص ابتلا به Covid-19 براساس یافته های بالینی و یافته های حاصل از تصویربرداری (Chest X Ray)، سی تی اسکن یا PCR
تمایل به شرکت در مطالعه
سن 20-75 سال
تشخیص ابتلا به Covid-19 براساس تست PCR
تمایل به شرکت در مطالعه سن 20-75 سال تشخیص ابتلا به Covid-19 براساس یافته های بالینی و یافته های حاصل از تصویربرداری (Chest X Ray)، سی تی اسکن یاتست PCR
Age less than 20 and more than 75 years
Taking warfarin
Sensitivity to plant products such as turmeric and pepper
Age less than 20 and more than 75 years
Taking warfarin
Sensitivity to herbal products such as turmeric and pepper
Age less than 20 and more than 75 years Taking warfarin Sensitivity to plantherbal products such as turmeric and pepper
Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two curcumin and placebo groups.The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist. Researchers will not informed about randomization process until completion of data analyses.
Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two curcumin-piperine and placebo groups. The enrolling participants, and assigning participants to the groups will be carried out by a trained nutritionist. Researchers will not be informed about the randomization process until the completion of data analyses.
Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two curcumin-piperine and placebo groups.Thegroups. The enrolling participants, and assigning participants to the groups will be carried out by a trained nutritionist. Researchers will not be informed about the randomization process until the completion of data analyses.
به طور تصادفی بر اساس روش permuted block randomization با استفاده از بلوک هایی 4 تایی که بلوک بندی بر اساس متغیر جنس خواهد بود و به یکی از دو گروه کورکومین و دارونما تخصیص خواهند یافت. تخصیص تصادفی با استفاده از جدول اعداد تصادفی انجام خواهد گرفت. ورود افراد و تخصیص هر فرد به یکی از دو گروه توسط کارشناس تغذیه انجام خواهد شد. پژوهشگران در رابطه با روند تصادفی سازی تا انتهای انالیز آماری مطلع نخواهند شد.
به طور تصادفی بر اساس روش permuted block randomization با استفاده از بلوک هایی 4 تایی که بلوک بندی بر اساس متغیر جنس خواهد بود و به یکی از دو گروه کورکومین-پیپرین و دارونما تخصیص خواهند یافت. تخصیص تصادفی با استفاده از جدول اعداد تصادفی انجام خواهد گرفت. ورود افراد و تخصیص هر فرد به یکی از دو گروه توسط کارشناس تغذیه انجام خواهد شد. پژوهشگران در رابطه با روند تصادفی سازی تا انتهای انالیز آماری مطلع نخواهند شد.
به طور تصادفی بر اساس روش permuted block randomization با استفاده از بلوک هایی 4 تایی که بلوک بندی بر اساس متغیر جنس خواهد بود و به یکی از دو گروه کورکومین-پیپرین و دارونما تخصیص خواهند یافت. تخصیص تصادفی با استفاده از جدول اعداد تصادفی انجام خواهد گرفت. ورود افراد و تخصیص هر فرد به یکی از دو گروه توسط کارشناس تغذیه انجام خواهد شد. پژوهشگران در رابطه با روند تصادفی سازی تا انتهای انالیز آماری مطلع نخواهند شد.
This study is a double blind clinical trial (participant, researcher). The curcumin supplement and its placebo will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study.
This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine supplement and its placebo will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study.
This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine supplement and its placebo will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study.
این مطالعه از نوع کارآزمایی بالینی دو سوکور (شرکت کننده، محقق) می باشد. مکمل کورکومین و دارونمای آن در جعبه های مشابه بسته بندی خواهند شد و پژوهشگر و بیماران تا انتهای مطالعه از محتوای بسته ها مطلع نخواهند
این مطالعه از نوع کارآزمایی بالینی دو سوکور (شرکت کننده، محقق) می باشد. مکمل کورکومین-پیپرین و دارونمای آن در جعبه های مشابه بسته بندی خواهند شد و پژوهشگر و بیماران تا انتهای مطالعه از محتوای بسته ها مطلع نخواهند
این مطالعه از نوع کارآزمایی بالینی دو سوکور (شرکت کننده، محقق) می باشد. مکمل کورکومین-پیپرین و دارونمای آن در جعبه های مشابه بسته بندی خواهند شد و پژوهشگر و بیماران تا انتهای مطالعه از محتوای بسته ها مطلع نخواهند
Intervention groups
#1
Control group: 2 placebos (500 mg of maltodextrin) daily after lunch and dinner for 2 weeks.
Control group: 2 placebo capsules ( containing 505 mg of maltodextrin) will be given daily after lunch and dinner for 2 weeks.
Control group: 2 placebosplacebo capsules (500 containing 505 mg of maltodextrin) will be given daily after lunch and dinner for 2 weeks.
گروه کنترل: روزانه 2 عدد دارونما (500 میلیگرممالتودکسترین) بعد ازناهار و شام به مدت 2 هفته دریافت خواهند کرد.
گروه کنترل: روزانه 2 عدد کپسول دارونما ( حاوی 505 میلیگرم مالتودکسترین) بعد از ناهار و شام به مدت 2 هفته دریافت خواهند کرد.
گروه کنترل: روزانه 2 عدد کپسول دارونما (500 میلیگرممالتودکسترین حاوی 505 میلیگرم مالتودکسترین) بعد ازناهاراز ناهار و شام به مدت 2 هفته دریافت خواهند کرد.
Protocol summary
Study aim
Determination of the effect of curcumin-piperine supplementation on disease duration, severity, and clinical signs and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
Design
This is a randomized, placebo-controlled, double-blind parallel-group clinical trial. One hundred participants will be randomly allocated to receive curcumin-piperine supplement per day (25 inpatients and 25 outpatients) or placebo (25 inpatients and 25 outpatients).
Settings and conduct
In this study, patients with coronavirus will be recruited from hospitals of Isfahan University of Medical Sciences. Subjects will be stratified according to gender. Random assignment will be done by the use of a table of random numbers. The enrolling participants, and assigning participants to the groups will be carried out by a relevant specialist.The curcumin-piperine supplement and its placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Tendency to participate in the study; People aged 18-65 years; Diagnosis of Covid-19 based on the PCR test.
Exclusion criteria: Age less than 20 and more than 75 years; Taking warfarin; Sensitivity to herbal products such as turmeric and pepper
Intervention groups
Individuals will be randomly assigned to two groups to receive the curcumin-piperine supplement (1000 mg/day of curcumin and 10 mg/day of piperine) or placebo (1010 mg of maltodextrin) for 2 weeks.
Main outcome variables
CT of the chest, body temperature, length of hospital stay, hs-CRP, ESR, ALT, AST, LDH, BUN, creatinine, CBC, blood oxidative stress indices ( SOD, MDA, TAC), Albumin, Severity of the disease, severity and number of coughs
General information
Reason for update
Correction of typos and updating of the sampling period
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N46
Registration date:2020-05-04, 1399/02/15
Registration timing:registered_while_recruiting
Last update:2020-10-31, 1399/08/10
Update count:1
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of curcumin-piperine supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
Public title
Effect of curcumin-piperine in patients with coronavirus (COVID-19)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to participate in the study
People aged 18-65 years
Diagnosis of Covid-19 based on the PCR test
Exclusion criteria:
Age less than 20 and more than 75 years
Taking warfarin
Sensitivity to herbal products such as turmeric and pepper
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two curcumin-piperine and placebo groups. The enrolling participants, and assigning participants to the groups will be carried out by a trained nutritionist. Researchers will not be informed about the randomization process until the completion of data analyses.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine supplement and its placebo will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.MUI.MED.REC.1399.049
Health conditions studied
1
Description of health condition studied
coronavirus (covid-19) disease
ICD-10 code
U07.02
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
CT of the chest
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Find out - Photos - CT
2
Description
Body temperature
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
By using clinical thermometer
3
Description
Duration of hospitalization
Timepoint
At the time of discharge from the hospital
Method of measurement
By Using the patient's medical record
4
Description
hs-CRP
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic method
5
Description
ESR
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic method
6
Description
ALT
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic photometric method
7
Description
AST
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic photometric method
8
Description
LDH
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic photometric method
9
Description
BUN
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
urine sample
10
Description
creatinine
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
by laboratory kit
11
Description
CBC
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
blood sample
12
Description
blood oxidative stress indices ( SOD, MDA, TAC)
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
By using available commercial kits
13
Description
Albumin
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
blood sample
14
Description
Severity of the disease
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
By using clinical and laboratory evaluations
15
Description
severity and number of coughs
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Visual analogue scales (VAS) for cough
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two curcumin-piperine capsules (500 mg of curcumin + 5 mg of piperine) will be given daily for 2 weeks after lunch and dinner.
Category
Treatment - Other
2
Description
Control group: 2 placebo capsules ( containing 505 mg of maltodextrin) will be given daily after lunch and dinner for 2 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated with Isfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Hezar Jarib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezarjarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The collected deidentified for the primary outcome measure only will be shared.
When the data will become available and for how long
12 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
To conduct similar studies
From where data/document is obtainable
askari@mui.ac.ir
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request.