| CTRI Number |
CTRI/2019/02/017799 [Registered on: 25/02/2019] Trial Registered Prospectively |
| Last Modified On: |
21/02/2019 |
| 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-
Hindi Zeeqi |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmocopoeial Formulation Habb-e-Hindi Zeeqi in Zeequn Nafas (Bronchial Asthma) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZN/BA/HHZ/CLNVAL/CCRUM/17-18, Version 1, Date 23.07.2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Room No - 523, 5th Floor, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Room No - 507, 5th Floor,Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Path) SIV |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Room No - 516, 5th Floor,Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Central Council for Research in Unani Medicine(CCRUM), 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 Mohd Manzar Alam |
Regional Research Institute of Unani Medicine (RRIUM) |
Guzri, Patna City
Research OPD Room (Zeequn Nafas)
Patna
BIHAR |
7488966960
manzar.medicine@gmail.com |
| Prof Naquibul Islam |
Regional Research Institute of Unani Medicine (RRIUM) |
Naseem Bagh Campus, University of Kashmir
Research OPD Room (Zeequn Nafas)
Srinagar
JAMMU & KASHMIR |
9469154930
naquibislam@gmail.com |
| Dr Fakhre Alam |
Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Post Box 70, Near Head Post Office
Research OPD Room (Zeequn Nafas)
Aligarh
UTTAR PRADESH |
9411653041
fakhrealamx7598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Aligarh |
Approved |
| Regional Research Institute of Unani Medicine, Patna |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Srinagar |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Hindi Zeeqi |
One tablet (125mg) orally twice daily with lukewarm 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. Males and females of 18-65 years
2. Objective evidence for reversible airway obstruction (≥12% and ≥200 mL change in
FEV1 and/or a 25% and 60 L/min change in PEFR) either spontaneously or after
treatment
3. Asthma for at least 6 months before enrollment |
|
| ExclusionCriteria |
| Details |
The patients of Zeeq-un-Nafas (Bronchial Asthma) with following conditions will be
excluded from the study:
1. FEV1/FVC ratio < 50%
2. Pregnant and lactating mother
3. Patient with other Respiratory Tract Infections, tuberculosis and malignancy.
4. Patient with co-morbidities, Diabetes Mellitus, Hepatic and Renal Insufficiency.
5. Patient with regular use of oral or systemic corticosteroids for conditions other than
Asthma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Zeequn Nafas (Bronchial Asthma) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 3 |
|
Date of First Enrollment (India)
|
28/02/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as a multicentric open trial in patients with Zeequn Nafas (Bronchial Asthma). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. 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-Hindi Zeeqi
|
S. No.
|
Ingredients
|
Botanical /
Chemical Name
|
Quantity
|
|
1.
|
Beesh
Mudbbar
|
Aconitum
ferox
Wall. Ex. Ser.
|
15gm
|
|
2.
|
Post-e-Bekh-e-Madar
|
Calotropis
procera
(Ait) R. Br.
|
30gm
|
|
3.
|
Aab-e-Adrak
|
Zingiber officinale
Rosc
|
30
gm
|
|