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IRCT20170315033086N10 IRCT 2021-03-14 Shahid Beheshti University of Medical Sciences Investigation of the efficacy of inflawell syrup on covid-19 patients Evaluation of the effect of inflawell-syrup on the immune response and the signaling pathway of NF-kB in peripheral blood mononuclear cell in patients with COVID-19: Double blind, placebo-controlled randomized clinical trial 2021-03-05 anticipated 40 Complete https://irct.ir/trial/51631 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is designed based on four-sized block randomization procedure. A non-ordered computer sequence list including the intervention, the patient-assigned code (patient code) and the order of recruitment (referral code) is generated by Stata v.15. In each four-sized block there are two drugs and two placebo intervention. There are also six modes for four-sized block layout which used by software in order to randomization. In addition to the intervention type , the computer list also includes two sets of number. one of them is related to the order of referral sequence or recruitment, which starts from the number one and goes in order. The other set is related to the patient code, which consists of non-consecutive and irregular three-digit numbers, and thus the type of intervention can not be guessed from the order in which patients enter the study. For example, the first person has a three-digit number as a special code. In order to do randomization and concealment, the patient codes are placed inside the concealed envelopes, the sequence of patient referral is written on envelopes. The patient code is also written on the medicine bottle (drug or placebo). In this way, following screening patients based on the inclusion and exclusion criteria and obtaining informed consent, according to the order of referral, the relevant envelope is opened and assigned code is given to the patient and then a bottle with the same code is given to the patient. Thus, the process of participants' allocation into each treatment group is completely random and unpredictable, Blinding description: Patient allocation and sequencing are done blindly. All the members of the staff who are involved in performing the enrollment, physicians, nurses and the investigation team as well as patients and their guardians, are masked and uninformed of drug and/or placebo prescription. Referral sequence will be written on the sealed envelopes and patient code will be written in the envelopes and the medication bottles (both drug and placebo). Following patient assessment by the doctor based on inclusion and exclusion criteria, according to the admission sequence, the envelopes with the same number will be opened. According to the patient code, the patients are going to be handed a bottle with the same code. Therefore, the patient is unbeknownst whether the intervention is drug or the placebo. 2 COVID-19. Intervention 1: Intervention group: patients will receive standard treatments and inflawell syrup (Provided by KondorPharma Co, Canada) containing standardized Boswellic acids powder 3 times a day 10 milliliter each time for 14 days. Intervention 2: Control group: Placebo receiving group will take standard treatments and placebo syrup, provided by KondorPharma Company (Canada), 3 times a day 10 cc each time for 14 days. Yes - There is a plan to make this available What will be shared: Collected IPD will be shared after de-identification of participants and patients. When: De-identified data will be available starting from April, 2025 To whom: Academics employed at various research/university institutions and the industry Conditions: No condition is specified. Where to obtain: Saeed Karima, Floor 8th, Department of Clinical Biochemistry, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Tel: +982122439975 How to obtain: The applicant would be asked to provide a written formal request letter, containing the importance of the data and the project processes. Following the receipt of request letter, the data would be provided in no more than two weeks. Comments:
public Mohammadreza Salehi
Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1587 karima@sbmu.ac.ir Tehran University of Medical Sciences scientific Somayeh Mahmoodi Baram
Koodkiar Dead End, Daneshjoo Blvd., Yemen St., Shahid Chamran Highway, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 s.mahmoodi.bch@gmail.com Behbalin Iran (Islamic Republic of) COVID-19 patient admitted to the infectious ward of the hospital Age ≥ 18 years in both sexes Confirmation of SARS-CoV2 infection based on PCR test and clinical manifestations including: 1. Respiratory distress (breathing ≥ 25 times per minute) or 2. Percentage of oxygen saturation at rest ≤92% Early diagnosis (less than or equal to 8 days from the onset of symptoms) Signing the informed consent form 18 years no limit Both Liver, kidney and heart failure Inability of the patient to consume the oral form Pregnancy and lactation or positive pregnancy test Participate in two or more clinical trials simultaneously B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: patients will receive standard treatments and inflawell syrup (Provided by KondorPharma Co, Canada) containing standardized Boswellic acids powder 3 times a day 10 milliliter each time for 14 days. Control group: Placebo receiving group will take standard treatments and placebo syrup, provided by KondorPharma Company (Canada), 3 times a day 10 cc each time for 14 days Duration of hospital stay. Timepoint: Day 7 and 14 after the intervention. Method of measurement: Number of days. C-reactive protein (CRP). Timepoint: Baseline and 14 days after intervention. Method of measurement: ELISA technique. Behbalin Approved 2020-10-13 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Koodkiar Dead End ,Daneshjoo Blvd., Yemen St., Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)