| CTRI Number |
CTRI/2018/10/016176 [Registered on: 29/10/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study to see the effect of Unani medicine Habb e Surfa in Surfa Yabis (Cough)
|
|
Scientific Title of Study
|
Clinical Validation of Unani Classical drugs i.e. Habb-e-Surfa in
Surfa Yabis (Dry Cough) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asif Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Central Council for Research in Unani Medicine
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 |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Central Council for Research in Unani Medicine
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 SCIENTIST III |
| Affiliation |
Ministry of AYUSH |
| Address |
Central Council for Research in Unani Medicine
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
1100158
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural Support: 1. Clinical Research Unit, Burhanpur 2. Clinical Research Unit, Bhopal 3. Regional Research Unit (RRC), Allahabad Monetary Support: Central Council for Research in Unani Medicine, New Delhi |
|
|
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, 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 Faisal |
Clinical Research Unit |
Research OPD (Surfa Yabis) Department of Pharmacology, Gandhi Medical College
Bhopal
MADHYA PRADESH |
09827082483
crubpl.incharge@gmail.com |
| Dr Mujahid Sami |
Clinical Research Unit, Burhanpur |
Research OPD (Surfa Yabis)
Ganpati Naka, Burhanpur
West Nimar
MADHYA PRADESH |
09827541428
mahajankk@rediffmail.com |
| Dr Mohd Ehsan Ansari |
Regional Research Center |
Research OPD (Surfa Yabis)
B501/4, GTB Nagar, Opposite Dulhan Palace
Allahabad
UTTAR PRADESH |
0987598542
dr.mehsan.ansari786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Allahabad |
Submittted/Under Review |
| Clinical Research Unit, Bhopal |
Submittted/Under Review |
| Clinical Research Unit, Burhanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R05||Cough, Surfa Yabis (Cough), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb e Surfa |
one tablet (125mg) twice daily. Nil orally for half an hour after taking medicine
for two weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 18-60
2. Surfa YÄbis (Dry Cough) of < 3 weeks duration
|
|
| ExclusionCriteria |
| Details |
1. Upper respiratory tract Infections having productive cough.
2. Lower Respiratory Tract Infections (LRI or LRTI) including pneumonia, lung abscess, and acute bronchitis.
3.Chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema.
4. Bronchiectasis, pulmonary tuberculosis, pulmonary oedema, interstitial pulmonary fibrosis
5. Tumours of larynx, bronchi, and lungs
6. High Grade Fever > 101oF
7. Drug-induced Cough (e.g., ACE Inhibitors)
8. Diabetes Mellitus, Hypertension
9. Known cases of severe hepatic, renal or cardiac ailments
10. H/o addiction (smoking, alcohol, drugs)
11. 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 signs and symptoms of Surfa Yabis (Cough) |
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
at baseline and at the end of treatment |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
24/03/2016 |
| 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) |
Open to Recruitment |
|
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 Surfa YÄbis (Dry Cough) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on Baseline and of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. |
The Ingredients of the formulation as mentioned in the National Formulary of Unani Medicine Part I are as under: | S. No. | Ingredients | Quantity | -
| Asl-us-Soos | 20 g | -
| Tukhm-e-Khubbazi | 20 g | -
| Maghz-Tukhm-e-Kaddu Shireen | 20 g | -
| Samagh-e-Arabi Biryan | 15 g | -
| Kateera | 15 g | -
| Nishasta-e-Gandum | 15 g | -
| Zafran | 5 g | |