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IRCT20231025059862N1 IRCT 2023-11-06 Neyshabour University of Medical Sciences Investigating the effect of "Taryaqe Vabaei " in cold-like infections Investigating the effect of herbal composition "Taryaqe Vabaei" on the severity of symptoms of patients with upper respiratory infections with cold-like symptoms: a randomized controlled clinical trial 2023-11-22 anticipated 66 Complete https://irct.ir/trial/73398 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples to be studied will be selected by available sampling from among those who refer to the mentioned centers.Then these samples will be divided into two groups by simple randomization method. First, according to the number of samples in each group, the letters A (intervention group) and B (control group) are written in the envelopes, Blinding description: According to the type of study (double-blind), blinding is done for the research doctor and the participants. 3 Condition 1: upper respiratory infections. Condition 2: Upper respiratory infections. Intervention 1: In the intervention group, while receiving the relevant standard treatment, the capsule of herbal "Taryaqe Vabaei" for epidemics containing the extract of yellow patience, myrrh and saffron along with the method of use (two capsules of 500 mg per day for 14 days) in the packaging made by Niak Pharmaceutical Company, delivered by the company are given. Intervention 2: In the control group, a placebo capsule (two 500 mg capsules containing starch per day for 14 days) similar to the original drug in terms of shape, color and size in the packaging prepared by Niak Pharmaceutical Company, is prescribed and treated similarly to the intervention group. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: 6 months after the results are published To whom: Researchers, pharmacists and doctors Conditions: For research and medical purposes Where to obtain: Neyshabur University of Medical Sciences How to obtain: Registration of application - processing - non-contradiction with university rules and research ethics - disposal Comments:
public Saeed SepehriKia
No. 5, 29 Alley, 17 Shahrivar St
Neyshabour Iran (Islamic Republic of) 4917813171 +98 51 4333 5315 leg_med_ny@yahoo.com Neyshabour University of Medical Sciences scientific Mehdi Zarvandi
Shahid Sayad Shirazi 27, Naranj building, 3rd floor
Gorgan Iran (Islamic Republic of) 4917813171 +98 17 3245 2651 leg_med_ny@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Age 30 to 50 years, , presence of mild and outpatient symptoms of upper respiratory infection, 30 years 50 years Both History of allergy to herbal medicines in the composition, History of diabetes History of hypokalemia,cardiovascular disease or digoxin use, History of hypothyroidism Pregnancy and breastfeeding Participation in another clinical study of upper respiratory infection with cold-like symptoms in the 2 months before entering the present study. J00 J00 Acute upper respiratory infections Acute nasopharyngitis [common cold] Treatment - Drugs Treatment - Drugs In the intervention group, while receiving the relevant standard treatment, the capsule of herbal "Taryaqe Vabaei" for epidemics containing the extract of yellow patience, myrrh and saffron along with the method of use (two capsules of 500 mg per day for 14 days) in the packaging made by Niak Pharmaceutical Company, delivered by the company are given. In the control group, a placebo capsule (two 500 mg capsules containing starch per day for 14 days) similar to the original drug in terms of shape, color and size in the packaging prepared by Niak Pharmaceutical Company, is prescribed and treated similarly to the intervention group. Severity of symptoms of upper respiratory infection with cold-like symptoms. Timepoint: On day zero, at the end of the first week and at the end of the second week. Method of measurement: Visual Analogue Scale standard questionnaire and clinical information checklist. Neyshabour University of Medical Sciences Approved 2023-10-18 Ethics Committee of Neyshabur University of Medical Sciences 17 Shahrivar St. 29 Number 5 Neyshabur Razavi Khorasan Iran (Islamic Republic of)