Protocol summary
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Study aim
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This study aimed to compare the effectiveness of turmeric and ginger on clinical manifestations and laboratory findings of patients with Covid-19.
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Design
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Triple blind, randomized clinical trial, with control group, with a parallel group design of 90 patients with Covid-19.
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Settings and conduct
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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).
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2021-08-31, 1400/06/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-16, 1400/06/25
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Expected recruitment end date
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2022-03-20, 1400/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effectiveness of Turmeric and Ginger on the clinical manifestations and laboratory findings of patients with Covid-19
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Public title
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Comparison of the effectiveness of Turmeric and Ginger on the clinical manifestations and laboratory findings of patients with Covid-19
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-08-24, 1400/06/02
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Ethics committee reference number
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IR.SEMUMS.REC.1400.105
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19
Primary outcomes
1
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Description
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Fever
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Timepoint
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From the beginning of the intervention until the fifth day
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Method of measurement
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Fever will be measured using a mercury thermometer.
2
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Description
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Cough
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Timepoint
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From the beginning of the intervention until the fifth day
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Method of measurement
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Severity of cough will be measured using the visual analog scale (VAS).
3
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Description
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Fatigue
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Timepoint
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From the beginning of the intervention until the fifth day
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Method of measurement
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Severity of fatigue will be measured using the visual analog scale (VAS).
4
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Description
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Sore throat
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Timepoint
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From the beginning of the intervention until the fifth day
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Method of measurement
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Severity of sore throat will be measured using the visual analog scale (VAS).
5
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Description
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Nasal congestion
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Timepoint
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From the beginning of the intervention until the fifth day
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Method of measurement
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Severity of nasal congestion will be measured using the visual analog scale (VAS).
6
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Description
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Diarrhea
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Timepoint
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From the beginning of the intervention until the fifth day
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Method of measurement
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The severity of diarrhea will be assessed by the number of times a day.
7
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Description
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Dyspnea
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Timepoint
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From the beginning of the intervention until the fifth day
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Method of measurement
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Severity of dyspnea will be measured using the visual analog scale (VAS).
Secondary outcomes
1
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Description
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Complete blood count (CBC)
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention)
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Method of measurement
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Using the relevant laboratory kits
2
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Description
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Erythrocyte sedimentation rate (ESR)
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention)
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Method of measurement
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Using the relevant laboratory kits
3
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Description
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C-reactive protein (CRP)
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention)
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Method of measurement
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Using the relevant laboratory kits
4
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Description
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Lactate dehydrogenase (LDH)
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Timepoint
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At the beginning of the study (before the intervention) and at the end of the study (completion of the intervention)
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Method of measurement
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Using the relevant laboratory kits
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
3
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable