| CTRI Number |
CTRI/2024/09/073895 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of cough for a long time with Unani medicine Laooq-e-Unsul |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial formulation Laooq-e-Unsul for symptomatic relief in patients of Sual-e-Muzmin (Chronic Cough) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SM/CC/LU/CLNVAL/CCRUM 22-23, version 01, 07.06.22 |
NIL |
|
|
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
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
DELHI
110058
India |
| Phone |
9811810454 |
| Fax |
|
| Email |
ghazala.javed@gov.in |
|
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
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1. Regional Research Institute of Unani Medicine (RRIUM), Kolkata 2.Regional Research Institute of Unani Medicine (RRIUM), Aligarh 3. National Research Institute of Unani Medicine for Skin Disorders, Hyderabad; 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Anis Ansari |
National Research Institute of Unani Medicine for Skin Disorders |
Research OPD Room Sual-e-Muzmin (Chronic Cough),AG Colony Road, Opp. ESI Hospital, Erragadda
Hyderabad
TELANGANA |
9044124159
mohdanees120393@gmail.com |
| Dr Mohd Masihuzzaman Ansari |
Regional Institute of Unani Medicine (RRIUM) |
Research OPD Room Sual-e-Muzmin (Chronic Cough),First floor, 250A/29, G.T. Road (North) near Jaiswal Hospital Liluah, Howrah
Kolkata
WEST BENGAL |
9101317733
masi.ansari.dr@gmail.com |
| Dr Parvez Khan |
Regional Institute of Unani Medicine (RRIUM) |
Research OPD Room Sual-e-Muzmin (Chronic Cough), Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH |
9411059371
waytoparvez@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, Hyderabad |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R05||Cough, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laooq-e-Unsul |
5gm (semisolid) orally to be taken with water twice daily for 4 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. Sual-e-Muzmin (Chronic cough) of more than 8 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. History of Bronchiectasis, pulmonary tuberculosis, pulmonary edema, interstitial pulmonary fibrosis
5. Known cases of Tumors of larynx, bronchi, and lungs
6. Drug history of ACE Inhibitors
7. Known cases of 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 |
| The efficacy of the study drugs will be assessed on the basis of Cough Severity Index |
At 1st, 2nd and 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination |
At baseline and at the end of treatment for 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
16/09/2024 |
| 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 Yet Recruiting |
| 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 multi centric open trial in patients with Sual-e-Muzmin (Chronic Cough). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at 1st, 2nd and 3rd week for 4weeks. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 4weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Laooq-e-Unsul : | S.No. | Name of the Ingredient | Botanical/ English name | Quantity | -
| Unsul Biryan | Urginea indica (Roxb.) Kunth | 10 g | -
| Beikh-e-Irsa | Iris ensata Thunb. | 35 g | -
| Farasiyun/tagar | Valeriana jatamansi | 5 g | -
| Zufa Khushk | Hyssopus officinalis Linn. | 5 g | -
| Qand-e-Safaid | Saccharum officianale | Q.S. | |