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Preparation of herbal syrup formulation (Fran), and its effectiveness in improving adult patients with chronic and subacute cough

Protocol summary

Study aim
The purpose of this study is to prepare a herbal syrup containing 11 effective medicinal plants, including eucalyptus, thyme, Mallow, green tea, Hollyhocks, ginger, hyssop, Echinacea angustifolia, garlic, Marrubium and peppermint, and its effectiveness in treating patients with chronic and subacute coughs.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients. randomization.org was used for randomization.
Settings and conduct
This study is a randomized, double-blind, placebo-controlled clinical trial, which will be conducted in Yalda Clinic and 16 Azar Clinic in Tehran. Patients meeting the inclusion criteria will receive a pre-randomized identical-looking drug or placebo, which will be delivered to participants in the order of admission and will be administered for 10 days. The follow-up of the patients' health status will continue for 20 days. In this way, the patient, physician and outcome assessors will be blinded to the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adults aged 18-80 years; Visiting a physician for unexplained cough or persistent cough; Informed consent Exclusion criteria: Allergy to eucalyptus, thyme, Mallow, green tea, Hollyhocks, ginger, hyssop, Echinacea angustifolia, garlic, Marrubium and peppermint
Intervention groups
Patients in both drug and placebo groups will take 5 cc every 8 hours of herbal product or placebo. The main treatment in both groups of patients includes Montelukast and N-acetylcysteine.
Main outcome variables
Cough-related quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240703062321N1
Registration date: 2024-07-11, 1403/04/21
Registration timing: prospective

Last update: 2024-07-11, 1403/04/21
Update count: 0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Mahnaz Khanavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4706
Email address
khanavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-21, 1403/04/31
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation of herbal syrup formulation (Fran), and its effectiveness in improving adult patients with chronic and subacute cough
Public title
Investigating the effectiveness of herbal syrup in improving adult patients with chronic and subacute cough
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged 18-80 years Visiting a physician for unexplained cough (ie, no associated diagnosis) or persistent cough (eg, cough that has persisted after treatment for associated diagnoses of asthma, rhinitis, gastroesophageal reflux disease, use of angiotensin-converting enzyme inhibitors) Informed consent
Exclusion criteria:
Allergy to eucalyptus, thyme, Mallow, green tea, Hollyhocks, ginger, hyssop, Echinacea angustifolia, garlic, Marrubium and peppermint Cough with infectious sputum Pregnancy/breastfeeding Significant mental or neurological disorder Patients with the possibility of surgery in the next two weeks Patients with a history of gastrointestinal bleeding Diabetic patients with uncontrollable blood sugar in the last three months
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization was performed in blocks of 4 by randomization.org, concealed in numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining informed consent, patients will receive the same-looking drug or placebo from a nurse. The doctor is also not aware of the order of the random sequence. In this way, the patient, physician and outcome assessors will be blinded to the intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz and Quds Boulevard intersection,
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2025-06-24, 1404/04/03
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.058

Health conditions studied

1

Description of health condition studied
Chronic cough
ICD-10 code
R05
ICD-10 code description
Cough

Primary outcomes

1

Description
The primary outcome is cough-related quality of life at 20 days after randomization. The validated score of the Leicester cough questionnaire will be used to evaluate the effect of the drug on the patients' quality of life (the mean difference between the arms measured 20 days after randomization). Total LCQ points will be calculated. The LCQ is also suitable for recording longitudinal improvements in cough and cough-related recovery
Timepoint
Baseline, third and twentieth days
Method of measurement
Leicester Cough Questionnaire (LCQ)

Secondary outcomes

1

Description
Cough-related quality of life with LCQ score. The sub-domains of quality of life related to physical, psychological and social cough. Total cessation of cough on the third and twentieth days after starting treatment with medicine or placebo. Incidence of re-visit to physician and/or hospitalization for possible worsening of disease and occurrence of adverse events within 20 days after randomization. Incidence of adverse events within 20 days after randomization
Timepoint
Baseline, third and twentieth days
Method of measurement
Leicester Cough Questionnaire

Intervention groups

1

Description
Intervention group: Patients in the intervention group will consume 5 cc every 8 hours of a herbal syrup (Fran) containing eucalyptus, thyme, Mallow, green tea, Hollyhocks, ginger, hyssop, Echinacea angustifolia, garlic, Marrubium and mint for 10 days. The follow-up of the patients' health status will continue for 20 days.
Category
Treatment - Drugs

2

Description
Control group: patients in Placebo group will take 5 cc every 8 hours of placebo syrup containing water, permitted food coloring and sweetener for 10 days, and the follow-up of patients' health status will continue for 20 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
16 Azar clinic
Full name of responsible person
Maede Hasanpour
Street address
16 Azar clinic, 16 Azar street, Enghelab Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6111 3090
Email
mhasanpour@farabi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Central Organization of Tehran University of Medical Sciences, corner of Qods St, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 8163 3102
Email
info@tums.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Nooshin Shahd Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Khanavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
16 Azar Street, Tehran university of medical sciences, faculty of pharmacy
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6412 0448
Email
khanavim@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Khanavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
16 Azar Street, Tehran university of medical sciences, faculty of pharmacy
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6412 0448
Email
khanavim@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maede Hasanpour
Position
research assistant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
16 Azar Street, Tehran university of medical sciences, faculty of pharmacy
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
0098214120448
Email
mhasanpour@farabi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data from the questionnaire can be shared
When the data will become available and for how long
After completing the study
To whom data/document is available
Pharmaceutical specialists, doctors and pharmaceutical companies
Under which criteria data/document could be used
More data will be available upon request via email and stating the reason for the request
From where data/document is obtainable
Dr. Khanavi - Dr. Hasanpour via e-mail or by visiting the Faculty of Pharmacy in Tehran mhasanpour@farabi.tums.ac.ir khanavim@tums.ac.ir
What processes are involved for a request to access data/document
After receiving the email, the request will be answered as soon as possible
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