| CTRI Number |
CTRI/2018/08/015398 [Registered on: 21/08/2018] 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 Majoon-e-Rahul Momineen. |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeal formulation Majoon Rahul Momineen in Zeeq un Nafas (Bronchial Asthma) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZN/BA/MRM/CLNVAL/CCRUM 16-17 version 1, 03.03.2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 507
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 507
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| 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 (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
110058
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Central Research Institute of Unani Medicine Hyderabad 2. Regional Research Institute of Unani Medicine Patna 3 Regional Research Institute of Unani Medicine Srinagar Monetary Support: Central Council For Research In Unani Medicine |
|
|
Primary Sponsor
|
| Name |
Central Council For Research In Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI 110058 India |
| 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 Syed Gulnawaz Ahmad |
Central Research Institute of Unani Medicine |
Research OPD Room Zeeq un Nafas (Bronchial Asthma)
A G Colony Road, Erragadda
Hyderabad
ANDHRA PRADESH |
9997603371
skgulnawaz@gmail.com |
| Dr Mahboob Us Salam |
Regional Research Institute of Unani Medicine |
Research OPD Room Zeeq un Nafas (Bronchial Asthma)
Guzri, Patna City
Patna
BIHAR |
9454177865
salam_mehboob@rediffmail.com |
| Dr Naquibul Islam |
Regional Research Institute of Unani Medicine |
Research OPD Room Zeeq un Nafas (Bronchial Asthma)
Naseem Bagh Campus, University of Kashmir
Srinagar
JAMMU & KASHMIR |
9469154930
naquibislam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine Hyderabad |
Approved |
| Regional Research Institute of Unani Medicine Patna |
Approved |
| Regional Research Institute of Unani Medicine Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, (2) ICD-10 Condition: J459||Other and unspecified asthma, (3) ICD-10 Condition: J459||Other and unspecified asthma, Zeeq un Nafas (Bronchial Asthma), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-e-Rahul Momineen |
Majoon Rahul Momineen Semisolid Oral 7g twice daily take with Lukewarm water for two weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 19-60
2. Patients of Bronchial Asthma presenting with the following symptoms:
Wheeze
Shortness of breath
Chest tightness and cough that vary over time and in intensity
Expiratory airflow limitation as suggested by a decreased FEV1
Patients with Asthma Control Questionnaire Score < 1.5
|
|
| ExclusionCriteria |
| Details |
The patients of Zeequn Nafas (Bronchial Asthma) with following conditions will be excluded from the study:
1. Patient with Upper Respiratory Tract Infections, Chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema.
2. Patient with medical conditions requiring long term treatment such as Pulmonary tuberculosis, Renal insufficiency Diabetes Mellitus, Hypertension etc
3. Patients with cognitive impairments
4. History of addiction (smoking, alcohol, drugs)
5. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the sign and symptoms of Zeeq un Nafas (Bronchial Asthma) |
Two Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
2 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 2 |
|
Date of First Enrollment (India)
|
21/08/2018 |
| 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 a multicentric 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 at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition of Majoon Rahul Momineen
|
S.No.
|
Ingredients
|
Botanical
|
Quantity
|
|
1
|
Jauzbuwa
|
Myristica fragrans Houtt.
|
45gm
|
|
2
|
Kateera
|
Cochlospermum religiosum (Linn.) Alston.
|
45gm
|
|
3
|
Irsa
|
Iris ensata Thunb.
|
45gm
|
|
4
|
Barg-e-Gaozaban
|
Borago officinalis Linn.
|
5gm
|
|
5
|
Khusyat-us-Salab
|
Orchis mascula Linn.
|
5gm
|
|
6
|
Tukhm-e-Gazar
|
Daucus
carota Linn.
|
120gm
|
|
7
|
Narjeel
|
Cocos nucifera Linn.
|
120gm
|
|
8
|
Darchini
|
Cinnamomum zeylanicum Blume.
|
120gm
|
|
9
|
Habb-e-Sanobar
|
Pinus gerardiana Wall.
|
120gm
|
|
10
|
Shaqaq-ul-Misri
|
Pastinaca secacul Linn.
|
210gm,
|
|
11
|
Sheera-e-Tukhm-e-Khashkhash
|
Papaver somniferum Linn.
|
300gm
|
|
12
|
Joshanda-e-Post-e-Khashkhash
|
Papaver somniferum Linn.
|
600gm
|
|
13
|
Asal or Qand Safaid
|
Honey or Sugar
|
5kg
|
|
14
|
Aab-e-Seb
|
Malus sylvestris Mill.
|
1.2ltr
|
|
15
|
Aab-e-Gazar
|
Daucus
carota Linn.
|
2ltr
|
|