| CTRI Number |
CTRI/2026/03/105609 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Unani Decoctions in Treating Cough with expectoration |
|
Scientific Title of Study
|
Therapeutic Evaluation of Unani Formulations in the Management of Iltihab al-Shuab Muzmin (Chronic Bronchitis) : A Randomized Single Blind Parallel Group Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asra Sadique |
| Designation |
MD Scholar (Unani) |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalajat, Faculty of Unani Medicine, AKTC, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8869873630 |
| Fax |
|
| Email |
asrasadique25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Tabassum Latafat |
| Designation |
Professor |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalajat, Faculty of Unani Medicine, AKTC, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8191916786 |
| Fax |
|
| Email |
tabassum94tariq@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asra Sadique |
| Designation |
MD Scholar (Unani) |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Moalajat, Faculty of Unani Medicine, AKTC, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8869873630 |
| Fax |
|
| Email |
asrasadique25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalajat, AKTCH, Aligarh Muslim University, Aligarh, UP, India, 202002 |
|
|
Primary Sponsor
|
| Name |
Department of Moalajat Ajmal Khan Tibbiya College Aligarh Muslim University |
| Address |
Department of Moalajat Ajmal Khan Tibbiya College, Aligarh Muslim University, Aligarh 202002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asra Sadique |
Ajmal Khan Tibbiya College and Hospital |
OPD No- 2 and 8 Dept of Moalajat, AKTCH, Faculty of Unani Medicine ,AMU, Aligarh
Aligarh
UTTAR PRADESH |
8869873630
asrasadique25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J410||Simple chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Decoction |
The formulation consists of Hyssopus officinalis (Zoofa Khusk) 6 g, Trigonella foenum-graecum (Hulba) 6 g, Glycyrrhiza glabra (Asl-us-Soos) 6 g, Iris ensata (Irsa) 6 g, along with 3 pieces of Ficus carica (Anjeer Zard) and 9 pieces of Vitis vinifera (Maweez Munaqqa) in the form of decoction twice a day orally for 2 months |
| Comparator Agent |
Decoction |
The formulation contains Hyssopus officinalis (Zoofa Yabis) 7 g, Adiantum capillus-veneris (Parsiaoshan) 7 g, Glycyrrhiza glabra (Asl-us-Soos) 10.5 g, and 10 pieces of Cordia dichotoma (Sapistan) in the form of decoction twice a day orally for 2 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 30-65 years.
Patients of either sex.
Patient presenting cough with expectoration of at least three months of two consecutive
years. Patient with FEV1 greater than or equal to 80 percent predicted (GOLD 1) and FEV1 more than 50 percent and less than 80 percent predicted
(GOLD 2) , FEV1/FVC ratio less than 70 percent of predicted value.
Prediabetic and diabetics (HbA1c less than 7%)
Patient of chronic bronchitis in a stable condition without any signs of acute
exacerbation of disease
Patient underwent atleast 2 weeks washout period before randomization
Those who give written consent |
|
| ExclusionCriteria |
| Details |
Acute exacerbation of disease
Bronchial Asthma
Patient demonstrating any radiographic evidence of infiltrates or pulmonary patches on Chest Xray
Cor Pulmonale and Congestive Heart Failure, Pregnant & lactating mothers
Patient having uncontrolled hypertension (BP greater then or equal to 160 by 100 mm Hg) , CLD, CKD
Patient on oxygen therapy
Obese Patients (BMI more than 30 kg per m2)
Patients who fail to give consent
Patients who fail to follow up
Mentally retarded persons |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Statistically significant increase in FEV1 observed from baseline to the end of the
study |
Day 0 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in score of total BCSS and Wheezing scale shows improvement in symptoms.
|
15th, 30th , 45th, 60th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, single-blind, parallel-group comparative clinical trial conducted at Ajmal Khan Tibbiya College and Hospital as part of the M.D. (Moalajat) program. The trial aims to evaluate and compare the therapeutic efficacy of two selected Unani formulations in the management of Iltihab al-Shu’ab Muzmin (Chronic Bronchitis), a clinical entity corresponding to chronic bronchitis under COPD. Participants diagnosed with chronic bronchitis will be randomly allocated into two groups and treated with different polyherbal decoctions. The first formulation contains Zoofa Khushk, Hulba, Irsa, Asl-us-Soos, Anjeer Zard, and Maweez Munaqqa, while the second formulation includes Asl-us-Soos, Parsiaoshan, Zoofa Yabis, and Sapistan. The study is designed to scientifically assess and compare their effects in relieving key symptoms such as cough, sputum production, breathlessness, and wheezing, based on predefined clinical parameters. The objective is to generate evidence regarding their anti-inflammatory, expectorant, mucolytic, bronchodilator, and concoctive properties in the management of chronic bronchitis. |