Protocol summary
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Study aim
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The effect of curcumin supplementation on clinical symptoms, acute phase reactants and cytokine interleukin 6 in patients with new Covid-19 admitted to hospital
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Design
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A double-blind clinical trial study with placebo
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Settings and conduct
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This study is a double-blind randomized clinical trial that will be performed in Ali Asghar, Shahid Faghihi and Namazi hospitals in Shiraz. In this study, 76 eligible patients whose PCR test was positive and hospitalized will be divided into two groups of 38 using a random number table.Curcumin and placebo are made by Elixir Nano Drug Company.
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Participants/Inclusion and exclusion criteria
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1. They have a positive PCR test or lung involvement in the imaging
2- Inpatients who are non -intubated
3- They are obove18 years old
4- They have filled in the informed consent form.
5. They are not pregnant or breastfeeding.
They do not have gallbladder inflammation or active gastrointestinal ulcers.
7. Patients do not have hemophilia or coagulation disease.
Severe renal failure, ie GFR 30 ml / min or dialysis patients.
9- Signing informed written consent.
10. Not participating in other clinical trials at the same time.
Exclusion criteria:
Patients who are allergic to turmeric or curcumin supplement.
Severe renal disease GFR 30 ml / min or dialysis patients.
Patients who do not take more than a quarter of curcumin supplements during the study period.
4- Connecting the patient to the ventilator
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Intervention groups
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The patients in the control group will receive the national standard diet for the treatment of coronavirus with placebo.
Patients in the curcumin group are treated with 160 mg of nanocurcumin for 14 days in addition to the standard regimen during hospitalization.
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Main outcome variables
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Clinical signs, Albumin concentration, CRP, ESR, Ferritin, Nutritional Risk Index (NRI), Interleukin-6
General information
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Reason for update
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Increase in secondary parameters that can be measured during the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211126053183N1
Registration date:
2021-12-13, 1400/09/22
Registration timing:
registered_while_recruiting
Last update:
2022-02-02, 1400/11/13
Update count:
1
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Registration date
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2021-12-13, 1400/09/22
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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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2021-12-11, 1400/09/20
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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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The effect of curcumin supplementaion on clinical symptoms , acute phase reactants and inflamatory cytokines in patients with covid-19 hospitalization
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Public title
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The effect of curcumin supplementaion on clinical symptoms , acute phase reactants and inflamatory cytokines in patients with covid-19 hospitalization
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
They have a positive PCR test or lung involvement in the imaging and 2- Hospitalized patients who are non-intubated. 3- They are over 18 years old .4- They have filled in the informed consent form5. 5-They are not pregnant or breastfeeding.6-They do not have gallbladder inflammation or active gastrointestinal ulcers.7. They do not have hemophilia or coagulation disease.8- renal failure with GFR <30 ml / min or dialysis patients.9- Signing informed written consent.10. Not participating in other clinical trials at the same time 11.cancer patients
Exclusion criteria:
1-Patients who are allergic to turmeric or curcumin.2- renal disease "GFR <30 ml / min" or dialysis patie.3-Patients who do not take more than a quarter of curcumin supplements during the study period.4- Connecting the patient to the ventilator
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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
- Care provider
- Investigator
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Sample size
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Target sample size:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We will classify patients in group A or B using a simple randomization method using the random number table tool. Which group belongs to group A or group B is also done randomly. Randomization is done by a statistical consultant who is in the stage of implementing the research project without responsibility. The main researcher and the doctor and the patient have no role in the randomization process and completely without Are informed.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The prescribing physician and patients participating in the research project are unaware that they have received the drug or placebo.
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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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2021-10-17, 1400/07/25
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Ethics committee reference number
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IR.SUMS.SCHEANUT.REC.1400.03
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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ICD-10 code description
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Primary outcomes
1
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Description
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Albumin, ferritin,CRP, ESR, interleukin 6,WBC,total lymphocyte count(TLC) Alanine Aminotransferase(ALT)(ALT),Aspartate Amino transferase(AST),LDH, resperatory oxygen saturation (SpO2) Nutritional Risk Index (NRI)
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Timepoint
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The first day of study, the fourteenth day of study
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Method of measurement
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Blood test, Nutritional Risk Index questionnaire
Intervention groups
1
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Description
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Intervention group: They receive 4 capsules of curcumin 40 mg daily made by Elixir Nano Drug Company for 14 days.
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Category
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Treatment - Other
2
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Description
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Control group: receive 4 placebo daily for 14 days
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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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Shiraz 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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A report on which patients are in the medication or placebo group, as well as a report on test results and questionnaires will be available
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When the data will become available and for how long
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9 months after publication
Results
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To whom data/document is available
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Our data will be accessible to those who are academic and scientific researchers
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Under which criteria data/document could be used
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The use of data for the development of other clinical trial studies or meta-analysis studies is unrestricted
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From where data/document is obtainable
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Send email to ahmadi.sedigheh@ymail.com or sjm@sums.ac.ir
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What processes are involved for a request to access data/document
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9 months after the publication of the article, an email will be sent to the listed address and the results will be sent within 2 month
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Comments
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