| CTRI Number |
CTRI/2018/08/015446 [Registered on: 23/08/2018] Trial Registered Prospectively |
| 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
|
Treatment of Dry Cough with Unani Medicine Khamira-e-Banafsha. |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial formulation Khamira banafsha for symptomatic relief in patients of Sual-e-Yabis (Dry Cough) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SY/DC/KB/CLNVAL/CCRUM 16-17 version 1 |
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 |
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 |
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 |
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
|
| Source of Monetary or Material Support Infrastructural support : 1 Central Research Institute of Unani Medicine (CRIUM), Hyderabad 2. Regional Research Institute of Unani Medicine(RRIUM), Aligarh Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
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 = 2 |
| 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 Sual-e-Yabis (Dry Cough)
A G Colony Road, Erragadda
Hyderabad
ANDHRA PRADESH |
9848716693
skgulnawaz@gmail.com |
| Dr Fakhre Alam |
Regional Research Institute of Unani Medicine |
Research OPD Room Sual-e-Yabis (Dry Cough)
Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH |
9411653041
fakhrealamx7598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine Hyderabad |
Approved |
| Regional Research Institute of Unani Medicine Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R05||Cough, (2) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Khamira-e-Banafsha |
7gm oraly with water twice a day for one week |
| 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. Sual-e-Yabis (Dry Cough) of < 3 weeks duration
|
|
| ExclusionCriteria |
| Details |
1. Acute Upper Respiratory Tract Infections (URI or URTI)
2. Acute 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. Drug-induced Cough (e.g., ACE Inhibitors)
7. Diabetes Mellitus, Hypertension
8. Known cases of severe hepatic, renal or cardiac ailments
9. H/o addiction (smoking, alcohol, drugs)
10.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 sign and symptoms of Sual-e-Yabis (Dry Cough) |
One week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome TimePoints
Hematological and biochemical assessments for safety |
One week |
|
|
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)
|
24/08/2018 |
| 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 Sual-e-Yabis (Dry Cough) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline and after one week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one weeks. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition of Khamira-e-Banafsha:
|
S.No.
|
Name of the Ingredient
|
Botanical/ English name
|
Part used
|
Quantity
|
-
|
Gul-e-Banafsha
|
Viola odorata Linn
|
Flower
|
200 gm
|
-
|
Aab
|
Purified water
|
Liquid
|
3 ltr
|
-
|
Qand-e-Safaid
|
Saccharum officianale
|
Crystals
|
1.6 kg
|
|