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IRCT20230125057216N1 IRCT 2023-09-26 Mazandaran University of Medical Sciences Evaluating the effect of curcumex supplement on the symptoms of patients with COVID-19 Evaluating the effect of curcumex supplement on the symptoms of patients with COVID-19 2023-03-21 anticipated 100 Complete https://irct.ir/trial/68497 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization was simple randomization, which was done using a table of random numbers. After determining the framework of the statistical population, among the 60 participants identified by numbers 1-60, 30 numbers are randomly extracted using the random number table, and these 30 participants are placed in the intervention group in the order of entry into the study as For example, if the numbers 3, 4, and 10 are obtained from the table of random numbers, it means that the third, fourth, and tenth patients included in the study will be in the intervention group, then the intervention group was given medicine and the control group was given placebo, which is both placebo and Both drugs were in completely similar packages, Blinding description: The present study was conducted in double blinded, in which the main researcher, health personnel involved in the study, participants and data analyzer were blind. The participants were divided into intervention and control groups, in addition to normal treatment, intervention group take medication and control group take placebo. medication and the placebo were in the form of capsules with the same color, shape and size and were distinguished only by inserting a batch number. 2 COVID-19. Intervention 1: Intervention group: In the intervention group, 30 patients were treated with Curcumex, which is a combination of three ingredients (320 mg of turmeric, 150 mg of ginger, and 4 mg of black pepper) in capsule form. This drug was developed by the Department of Pharmacology of Jundishapur University of Ahvaz. this medication use twice daily, which lasts up to 30 days. During the treatment period, patients will have three visits for training and control of clinical symptoms and laboratory findings. Intervention 2: Control group: In the control group, 30 patients were treated with placebo, which was similar in appearance to the original drug. This drug was developed by the Department of Pharmacology of Jundishapur University of Ahvaz. this medication use twice daily, which lasts up to 30 days. During the treatment period, patients will have three visits for training and control of clinical symptoms and laboratory findings. Yes - There is a plan to make this available What will be shared: After the end of the study, according to the rules of the Ethics Committee of the Ministry of Health, the non-identifiable data of the participants in the study will be published in a limited manner in the dissertation and article. When: The data access period starts one month after the publication of the study results. To whom: The data of this study will be available to researchers working in academic and scientific institutions. Conditions: The documentation of this study will be made available to other researchers for the purpose of conducting further research and for the purpose of using them in the production or development of drugs effective against the Covid-19. Where to obtain: The office of Dr. Gholamreza Houshmand is located at km 18 of Farah Abad Road, Department of Pharmacology, Faculty of Medicine. Email:Dr.houshmand_pharma@yahoo.com How to obtain: After receiving the request via email stating the need to receive data, this request will be reviewed by the main researcher and after the request is approved, the data will be sent. Comments:
public Gholamreza Houshmand
Farahabad Blvd
Sari Iran (Islamic Republic of) 481751665 +98 11 3354 3081 Dr.houshmand_pharmaco@yahoo.com Mazandaran University of Medical Sciences scientific Gholamreza Houshmand
Iran, mazandaran, sari, university of medical scince, department of pharmacology
Sari Iran (Islamic Republic of) 481751665 +98 11 3456 1759 Dr.houshmand_pharmaco@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) ground glass opacity in lung CT scan Clinical symptoms such as dry cough- dyspnea-fever- weakness- diarrhea- headache-rhinorrhea- or history of contact with COVID19 patient or recent travel to high-risk areas Positive Covid-19PCR 20 years 60 years Both PO intolerance Dissatisfaction for Participation in research U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: In the intervention group, 30 patients were treated with Curcumex, which is a combination of three ingredients (320 mg of turmeric, 150 mg of ginger, and 4 mg of black pepper) in capsule form. This drug was developed by the Department of Pharmacology of Jundishapur University of Ahvaz. this medication use twice daily, which lasts up to 30 days. During the treatment period, patients will have three visits for training and control of clinical symptoms and laboratory findings. Control group: In the control group, 30 patients were treated with placebo, which was similar in appearance to the original drug. This drug was developed by the Department of Pharmacology of Jundishapur University of Ahvaz. this medication use twice daily, which lasts up to 30 days. During the treatment period, patients will have three visits for training and control of clinical symptoms and laboratory findings. Investigation of the improvement rate of clinical symptoms of patients including cough, dyspnea, weakness, fever and diarrhea one month after take medication. Timepoint: At the beginning of the study and one month later. Method of measurement: history and physical examination. White blood cell counts. Timepoint: At the beginning of the study and after 30 days from the start of taking medication. Method of measurement: lab data. ESR. Timepoint: At the beginning of the study and after 30 days from the start of taking medication. Method of measurement: lab data. CRP. Timepoint: At the beginning of the study and after 30 days from the start of taking medication. Method of measurement: lab data. Comparison of the effect of Curcumex treatment on changes in serum creatinine. Timepoint: At the beginning of the study and after 30 days from the start of taking medication. Method of measurement: lab data. Comparison of the effect of Curcumex treatment on changes in liver enzymes. Timepoint: At the beginning of the study and after 30 days from the start of taking medication. Method of measurement: lab data. Mazandaran University of Medical Sciences Approved 2021-12-07 Ethics committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences and Health Services Building No. 2, Moalem Square, Sari Sari Mazandaran Iran (Islamic Republic of)