| CTRI Number |
CTRI/2025/07/092065 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Bronchial Asthma with Unani Medicine Habb-e-Filfil |
|
Scientific Title of Study
|
Clinical validation study to evaluate the safety and efficacy of Unani Pharmacopoeial formulation Habb-e-Filfil in Zeeq-un-Nafas (Bronchial Asthma) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZN/BA/HF/CLNVAL/CCRUM/23-24/ Version no-01, 05-05-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
DELHI
110058
India |
| Phone |
09811810454 |
| Fax |
|
| Email |
javed.ghazal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support:
1,National Research Institute of Unani Medicine for Skin Disorders
(NRIUMSD), Hyderabad
2.Regional Research Institute of Unani Medicine (RRIUM), Patna
3.Regional Research Institute of Unani Medicine (RRIUM), Silchar
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amir |
National Research Institute of Unani Medicine for Skin Disorders |
Research OPD Room Zeequn-NAfas(Bronchial Asthma), Opp. E.S.I., Hospital, A.G. Colony Road, Erragadda, Hyderabad – 500838
Hyderabad
TELANGANA |
7017474114
amirkhan.ccrum@ccrum.res.in |
| Dr Fatima Anjum |
Regional Research Institute of Unani Medicine |
Research OPD Room Zeequn-NAfas(Bronchial Asthma), Veterinary Bazar, Ghungoor, Silichar-788014,
Cachar
ASSAM |
9916452247
Fatimadr.ccrum@nic.in |
| Dr Md Manzar Alam |
Regional Research Institute of Unani Medicine |
Research OPD Room Zeequn-NAfas(Bronchial Asthma),Guzri, Patna City,
Patna– 800008
Patna
BIHAR |
9920245133
manzar.medicine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| National Research Institute of Unani Medicine for Skin Disorders |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Patna |
Approved |
| Regional Research Institute of Unani Medicine,silchar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Filfil
|
2 tab Twice Daily with water
For 4 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild and moderate cases of Bronchial Asthma (according to The Global Initiative for Asthma Classification) presenting with at least one of the following symptoms:
.Wheeze
.Shortness of breath
.Chest tightness and cough that vary over time and in intensity.
2.Participants with FEV1 between 60%-80% |
|
| ExclusionCriteria |
| Details |
1. Severe case of Bronchial asthma FEV1 BY less than 60%
2. known case of Interstitial lung disease.
3. known cases of chronic obstructive pulmonary disease (COPD).
4. Patient with regular use of oral or systemic corticosteroids for conditions other than Asthma.
5. Participants with other Respiratory Tract Infections, tuberculosis and malignancy.
6. Patients with diseases requiring long term treatment.
7. Patients with Mental disorders affecting drug compliance.
8.Participants with Tobacco Smoking.
9. Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of the study drug in the treatment of mild to moderate Zeeq un Nafas (Bronchial Asthma) will be carried out on the basis of Asthma Control Questionnaire (ACQ) and AQLQ (Asthma Quality of Life Questionnaire with standard activities) |
Weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haematological and biochemical investigations for safety assessment i.e., Hemogram,
LFT, KFT and Urine Examination: Routine & Microscopic. |
At baseline and at the end of treatment.i.e., 0 and 4th week |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 designed as a tri-centric open trial in patients with Zeeq-un-Nafas (Bronchial Asthma). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically weekly. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition of Habb-e-Filfil
|
S.
No.
|
Ingredients
|
Botanical /
Scientific Name
|
Quantity
|
|
1.
|
Rub- us -
soos
|
Glycyrrhiza glabra Linn.
|
10
gm
|
|
2.
|
Filfil Siyah
|
Piper
nigrum.
|
10
gm
|
|
3.
|
Qand Safaid
|
Saccharum officinarum L.
|
10 gm
|
|