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
Determining the effect of herbal composition "Taryaqe Vabaei" on the severity of symptoms of upper respiratory infection with cold-like symptoms
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 66 patients. The rand function of Excel software was used for randomization
Settings and conduct
A randomized clinical trial with a control group and double-blind (project researcher physician and participants) on 66 people with upper respiratory infections with cold-like symptoms, in the age range of 30 to 50 years, referring to health centers under Covering Neyshabor city affiliated to Neyshabor University of Medical Sciences. After random allocation, in the intervention group, the capsule of the "Taryaqe Vabaei" herbal combination (two 500 mg capsules per day for 14 days) will be delivered in the relevant packaging. Clinical symptoms will be evaluated based on standard VAS questionnaire and clinical information checklist. In the control group, placebo capsules similar to the original drug in terms of shape, color and size are prescribed in the respective packaging.
Participants/Inclusion and exclusion criteria
Age 30 to 50 years, presence of mild and outpatient symptoms of upper respiratory infection, no history of allergy to herbal medicines in the composition
Intervention groups
Patients with upper respiratory infections with cold-like symptoms
Main outcome variables
Severity of symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231025059862N1
Registration date:2023-11-06, 1402/08/15
Registration timing:prospective
Last update:2023-11-06, 1402/08/15
Update count:0
Registration date
2023-11-06, 1402/08/15
Registrant information
Name
Mehdi Zarvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3325 1653
Email address
dr.zarvandi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the effect of "Taryaqe Vabaei " in cold-like infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 50 years, ,
presence of mild and outpatient symptoms of upper respiratory infection,
Exclusion criteria:
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.
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
According to the type of study (double-blind), blinding is done for the research doctor and the participants
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Neyshabur University of Medical Sciences
Street address
17 Shahrivar St. 29 Number 5
City
Neyshabur
Province
Razavi Khorasan
Postal code
4917813171
Approval date
2023-10-18, 1402/07/26
Ethics committee reference number
IR.NUMS.REC.1402.019
Health conditions studied
1
Description of health condition studied
upper respiratory infections
ICD-10 code
J00
ICD-10 code description
Acute upper respiratory infections
2
Description of health condition studied
Upper respiratory infections
ICD-10 code
J00
ICD-10 code description
Acute nasopharyngitis [common cold]
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health-treatment centers of Neishabur city, under the coverage of Neishabur University of Medical Sc
Full name of responsible person
Saeed Sepehrikia
Street address
No. 5, 17 Shahrivar St
City
Neyshabour
Province
Razavi Khorasan
Postal code
4917813171
Phone
+98 51 4333 5315
Email
leg_med_ny@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Vice President of University Research and Technology
Street address
No. 5, 17 Shahrivar St
City
Neyshabour
Province
Razavi Khorasan
Postal code
4917813171
Phone
+98 51 4333 5315
Email
leg_med_ny@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?