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General information
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Increase in secondary parameters that can be measured during the study
Increase in secondary parameters that can be measured during the study
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افزایش پارامترهای ثانویه که حین انجام مطالعه قابل اندازه گیری می باشد.
افزایش پارامترهای ثانویه که حین انجام مطالعه قابل اندازه گیری می باشد.
Primary outcomes
#1
Albumin, ferritin,CRP, ESR, interleukin 6, Nutritional Risk Index (NRI)
آلبومین ، فریتین ،سی ار پی ،ای اس آر ،اینترلوکین 6،Nutritional Risk Index (NRI)
آلبومین ، فریتین ،سی ار پی ،ای اس آر ،اینترلوکین 6،تعداد گلبولهای سفید خون ، تعداد لنفوسیت های خون،لاکتات دهیدروژناز سرم، آلانین امینوترانسفراز سرم، آسپارتات امینوترانسفراز سرم ،فرکانس تنفسی در دقیقه، سطح اکسیژن خون شریانی، Nutritional Risk Index (NRI)
آلبومین ، فریتین ،سی ار پی ،ای اس آر ،اینترلوکین 6،تعداد گلبولهای سفید خون ، تعداد لنفوسیت های خون،لاکتات دهیدروژناز سرم، آلانین امینوترانسفراز سرم، آسپارتات امینوترانسفراز سرم ،فرکانس تنفسی در دقیقه، سطح اکسیژن خون شریانی، Nutritional Risk Index (NRI)
Protocol summary
Study aim
The effect of curcumin supplementation on clinical symptoms, acute phase reactants and cytokine interleukin 6 in patients with new Covid-19 admitted to hospital
Design
A double-blind clinical trial study with placebo
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Clinical signs, Albumin concentration, CRP, ESR, Ferritin, Nutritional Risk Index (NRI), Interleukin-6
General information
Reason for update
Increase in secondary parameters that can be measured during the study
Acronym
IRCT registration information
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
Registration date
2021-12-13, 1400/09/22
Registrant information
Name
Sedigheh Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3634 5074
Email address
ahmadi.sedigheh@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of curcumin supplementaion on clinical symptoms , acute phase reactants and inflamatory cytokines in patients with covid-19 hospitalization
Public title
The effect of curcumin supplementaion on clinical symptoms , acute phase reactants and inflamatory cytokines in patients with covid-19 hospitalization
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
The prescribing physician and patients participating in the research project are unaware that they have received the drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
amir 3,25/4 farhang shahr ,shahid rajaee Blvd ,shiraz