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Protocol summary
Double blind, randomized clinical trial, with control group, with a parallel group design of 90 patients with Covid-19.
Triple blind, randomized clinical trial, with control group, with a parallel group design of 90 patients with Covid-19.
DoubleTriple blind, randomized clinical trial, with control group, with a parallel group design of 90 patients with Covid-19.
کارآزمایی بالینی دوسویه کور، دارای گروه کنترل، با گروه های موازی، تصادفی شده بر روی 90 بیمار مبتلا به کووید-19.
کارآزمایی بالینی سهسویه کور، دارای گروه کنترل، با گروه های موازی، تصادفی شده بر روی 90 بیمار مبتلا به کووید-19.
کارآزمایی بالینی دوسویهسهسویه کور، دارای گروه کنترل، با گروه های موازی، تصادفی شده بر روی 90 بیمار مبتلا به کووید-19.
This study will be performed in the outpatient clinic of Kowsar hospital in Semnan. In the first group of the test, turmeric (corcoma tablets) in the amount of 500 mg 3 times a day for 5 days will be used. In the second group of the test, ginger (Vomigone tablets) in the amount of 500 mg 3 times a day for 5 days will be used. In the control group, patients will receive placebo tablets 3 times a day for 5 days. Assignment of patients to three groups was done in a simple random method using sealed envelopes. Because the drugs in the same bottles are opaque, marked only in letters, and even the doctor does not know their contents, the participant, the evaluator, and the person analyzing the results will not know how the patients are assigned to the groups (Double blind).
This study will be performed in the outpatient clinic of Kowsar hospital in Semnan. In the first group of the test, turmeric (corcoma tablets) in the amount of 500 mg 3 times a day for 5 days will be used. In the second group of the test, ginger (Vomigone tablets) in the amount of 500 mg 3 times a day for 5 days will be used. In the control group, patients will receive placebo tablets 3 times a day for 5 days. Assignment of patients to three groups was done in a simple random method using sealed envelopes. Because the drugs in the same bottles are opaque, marked only in letters, and even the doctor does not know their contents, the participant, the evaluator, and the person analyzing the results will not know how the patients are assigned to the groups (Triple blind).
This study will be performed in the outpatient clinic of Kowsar hospital in Semnan. In the first group of the test, turmeric (corcoma tablets) in the amount of 500 mg 3 times a day for 5 days will be used. In the second group of the test, ginger (Vomigone tablets) in the amount of 500 mg 3 times a day for 5 days will be used. In the control group, patients will receive placebo tablets 3 times a day for 5 days. Assignment of patients to three groups was done in a simple random method using sealed envelopes. Because the drugs in the same bottles are opaque, marked only in letters, and even the doctor does not know their contents, the participant, the evaluator, and the person analyzing the results will not know how the patients are assigned to the groups (DoubleTriple blind).
این مطالعه در کلینیک سرپایی بیمارستان کوثر سمنان انجام خواهد شد. در گروه اول آزمون از زردچوبه (قرص کورکوما) به میزان 500 میلیگرم 3 بار در روز برای مدت 5 روز استفاده خواهد شد. در گروه دوم آزمون از زنجبیل (قرص ومیگان) به میزان 500 میلیگرم 3 بار در روز برای مدت 5 روز استفاده خواهد شد. در گروه کنترل بیماران قرص پلاسبو را 3 بار در روز به مدت 5 روز دریافت خواهند کرد. تخصیص بیماران به سه گروه به روش تصادفی ساده و با استفاده از پاکتهاي مهر و موم شده است. از آنجا كه داروها در بطريهای مشابه، کدر که فقط با حروف مشخص شدهاند و حتی پزشک از محتوی آنها اطلاعی ندارد مشخص شدهاند، لذا شرکتکننده، ارزیاب و فرد تجزیه و تحلیل کننده نتایج از اختصاص بیماران به گروهها اطلاعی نخواهند داشت (دوسوکور).
این مطالعه در کلینیک سرپایی بیمارستان کوثر سمنان انجام خواهد شد. در گروه اول آزمون از زردچوبه (قرص کورکوما) به میزان 500 میلیگرم 3 بار در روز برای مدت 5 روز استفاده خواهد شد. در گروه دوم آزمون از زنجبیل (قرص ومیگان) به میزان 500 میلیگرم 3 بار در روز برای مدت 5 روز استفاده خواهد شد. در گروه کنترل بیماران قرص پلاسبو را 3 بار در روز به مدت 5 روز دریافت خواهند کرد. تخصیص بیماران به سه گروه به روش تصادفی ساده و با استفاده از پاکتهاي مهر و موم شده است. از آنجا كه داروها در بطريهای مشابه، کدر که فقط با حروف مشخص شدهاند و حتی پزشک از محتوی آنها اطلاعی ندارد مشخص شدهاند، لذا شرکتکننده، ارزیاب و فرد تجزیه و تحلیل کننده نتایج از اختصاص بیماران به گروهها اطلاعی نخواهند داشت (سهسوکور).
این مطالعه در کلینیک سرپایی بیمارستان کوثر سمنان انجام خواهد شد. در گروه اول آزمون از زردچوبه (قرص کورکوما) به میزان 500 میلیگرم 3 بار در روز برای مدت 5 روز استفاده خواهد شد. در گروه دوم آزمون از زنجبیل (قرص ومیگان) به میزان 500 میلیگرم 3 بار در روز برای مدت 5 روز استفاده خواهد شد. در گروه کنترل بیماران قرص پلاسبو را 3 بار در روز به مدت 5 روز دریافت خواهند کرد. تخصیص بیماران به سه گروه به روش تصادفی ساده و با استفاده از پاکتهاي مهر و موم شده است. از آنجا كه داروها در بطريهای مشابه، کدر که فقط با حروف مشخص شدهاند و حتی پزشک از محتوی آنها اطلاعی ندارد مشخص شدهاند، لذا شرکتکننده، ارزیاب و فرد تجزیه و تحلیل کننده نتایج از اختصاص بیماران به گروهها اطلاعی نخواهند داشت (دوسوکورسهسوکور).
General information
Double blinded
Triple blinded
doubltripl
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Due to participants were randomly assigned to groups using sealed envelopes containing the letters T, G, and C, each of which identifies intervention or control groups and drugs were identified in similar, opaque, letter-only bottles, and patients were treated on an outpatient basis at home, participants, the outcome assessor, and the data analyst were unaware of the allocation of individuals to experimentals and control groups, hence, study design changed to triple-blind.
Due to participants were randomly assigned to groups using sealed envelopes containing the letters T, G, and C, each of which identifies intervention or control groups and drugs were identified in similar, opaque, letter-only bottles, and patients were treated on an outpatient basis at home, participants, the outcome assessor, and the data analyst were unaware of the allocation of individuals to experimentals and control groups, hence, study design changed to triple-blind.
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از آنجا که بیماران به صورت تصادفی با استفاده از پاکت های مهر و موم شده حاوی حروف T، G و C به گروههای مداخله یا کنترل تخصیص یافتند و داروها در بطريهاي مشابه و كدر و فقط با حروف قابل شناسایی بودند (البته فقط استاد راهنمای مطالعه از این موضوع مطلع بود) و بیماران ه صورت سرپايي و در منزل درمان ميشدند، شرکت کننده و ارزیابی کننده پیامد و فرد تجزیه و تحلیل کننده دادههای مطالعه از اختصاص افراد به گروههای مداخله و کنترل بی اطلاع بودند، لذا، طراحی مطالعه به سه سوکور تغییر یافت.
از آنجا که بیماران به صورت تصادفی با استفاده از پاکت های مهر و موم شده حاوی حروف T، G و C به گروههای مداخله یا کنترل تخصیص یافتند و داروها در بطريهاي مشابه و كدر و فقط با حروف قابل شناسایی بودند (البته فقط استاد راهنمای مطالعه از این موضوع مطلع بود) و بیماران ه صورت سرپايي و در منزل درمان ميشدند، شرکت کننده و ارزیابی کننده پیامد و فرد تجزیه و تحلیل کننده دادههای مطالعه از اختصاص افراد به گروههای مداخله و کنترل بی اطلاع بودند، لذا، طراحی مطالعه به سه سوکور تغییر یافت.
Protocol summary
Study aim
This study aimed to compare the effectiveness of turmeric and ginger on clinical manifestations and laboratory findings of patients with Covid-19.
Design
Triple blind, randomized clinical trial, with control group, with a parallel group design of 90 patients with Covid-19.
Settings and conduct
This study will be performed in the outpatient clinic of Kowsar hospital in Semnan. In the first group of the test, turmeric (corcoma tablets) in the amount of 500 mg 3 times a day for 5 days will be used. In the second group of the test, ginger (Vomigone tablets) in the amount of 500 mg 3 times a day for 5 days will be used. In the control group, patients will receive placebo tablets 3 times a day for 5 days. Assignment of patients to three groups was done in a simple random method using sealed envelopes. Because the drugs in the same bottles are opaque, marked only in letters, and even the doctor does not know their contents, the participant, the evaluator, and the person analyzing the results will not know how the patients are assigned to the groups (Triple blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria:Definitive diagnosis of disease; Insensitivity to ginger and turmeric; Do not take anti-inflammatory drugs such as colchicine and Actemra. Exclusion criteria: unwillingness to continue participating in research.
Intervention groups
The first intervention group includes patients with Covid who receive turmeric supplement (corcoma pill).
The second intervention group includes patients with Covid who receive ginger supplement (Vomigan pill).
The control group includes patients with Covid who receive placebo pill.
Main outcome variables
Clinical manifestations (fever, cough, fatigue, sore throat, nasal congestion, diarrhea and dyspnea) and laboratory findings (CBC, ESR, CRP and LDH) of patients with Covid-19
General information
Reason for update
Due to participants were randomly assigned to groups using sealed envelopes containing the letters T, G, and C, each of which identifies intervention or control groups and drugs were identified in similar, opaque, letter-only bottles, and patients were treated on an outpatient basis at home, participants, the outcome assessor, and the data analyst were unaware of the allocation of individuals to experimentals and control groups, hence, study design changed to triple-blind.
Acronym
IRCT registration information
IRCT registration number:IRCT20120109008665N14
Registration date:2021-08-31, 1400/06/09
Registration timing:prospective
Last update:2025-06-16, 1404/03/26
Update count:1
Registration date
2021-08-31, 1400/06/09
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Turmeric and Ginger on the clinical manifestations and laboratory findings of patients with Covid-19
Public title
Comparison of the effectiveness of Turmeric and Ginger on the clinical manifestations and laboratory findings of patients with Covid-19
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years or older
Definitive diagnosis of Covid-19 disease (positive PCR, CT scan)
Absence of chronic hepatitis
Absence of cirrhosis
Absence of cholestatic liver disease
Absence of gallbladder inflammation
Absence of peptic ulcers
Lack of sensitivity to ginger
Lack of sensitivity to turmeric
Absence of women during pregnancy and lactation
Do not take anti-inflammatory drugs such as Colchicine and Actemra
Exclusion criteria:
Reluctance to continue participating in research
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples (to two experimental groups and one control group) will be done by simple random method using sealed envelopes. In this method, the letter T represents the turmeric group, the letter G represents the ginger group and the letter C represents the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants are randomly assigned to groups using sealed envelopes containing the letters T, G, and C, each of which identifies intervention or control groups. Because drugs will be identified in similar, opaque, letter-only bottles, and patients will be treated on an outpatient basis at home, participants, the outcome assessor, and the data analyst are unaware of the allocation of individuals to experimentals and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.SEMUMS.REC.1400.105
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Fever
Timepoint
From the beginning of the intervention until the fifth day
Method of measurement
Fever will be measured using a mercury thermometer.
2
Description
Cough
Timepoint
From the beginning of the intervention until the fifth day
Method of measurement
Severity of cough will be measured using the visual analog scale (VAS).
3
Description
Fatigue
Timepoint
From the beginning of the intervention until the fifth day
Method of measurement
Severity of fatigue will be measured using the visual analog scale (VAS).
4
Description
Sore throat
Timepoint
From the beginning of the intervention until the fifth day
Method of measurement
Severity of sore throat will be measured using the visual analog scale (VAS).
5
Description
Nasal congestion
Timepoint
From the beginning of the intervention until the fifth day
Method of measurement
Severity of nasal congestion will be measured using the visual analog scale (VAS).
6
Description
Diarrhea
Timepoint
From the beginning of the intervention until the fifth day
Method of measurement
The severity of diarrhea will be assessed by the number of times a day.
7
Description
Dyspnea
Timepoint
From the beginning of the intervention until the fifth day
Method of measurement
Severity of dyspnea will be measured using the visual analog scale (VAS).
Secondary outcomes
1
Description
Complete blood count (CBC)
Timepoint
At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention)
Method of measurement
Using the relevant laboratory kits
2
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention)
Method of measurement
Using the relevant laboratory kits
3
Description
C-reactive protein (CRP)
Timepoint
At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention)
Method of measurement
Using the relevant laboratory kits
4
Description
Lactate dehydrogenase (LDH)
Timepoint
At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention)
Method of measurement
Using the relevant laboratory kits
Intervention groups
1
Description
Intervention group: Group A (turmeric) receives 3 tablets of 500 mg of turmeric (curcuma) daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company.
Category
Prevention
2
Description
Intervention group: Group B (Vomigone) receives 3 tablets of 500 mg of ginger (Vomigone) daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company.
Category
Prevention
3
Description
Control group: Group C receives 3 tablets of 500 mg of placebo daily with standard treatment of Covid-19. The medicine will be given to the person by the therapeutic physician. Pills are taken by people before each meal.The pills are made by Dineh Pharmaceutical Company and contain compounds of polyvinyl pyrrolidone (PVP), microcrystalline cellulose (Avicel), starch and colorless.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital affiliated to Semnan University of Medical Sciences