| CTRI Number |
CTRI/2024/07/071434 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of throat infection with Unani medicine Habb-e-Khardal |
|
Scientific Title of Study
|
Clinical validation of Unani Pharmacopoeial formulation Habb-e-Khardal in Waram-e-Halaq (Pharyngitis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WH/P/HK/CLNVAL/22-23, version 01, 07-06-22 |
Protocol Number |
|
|
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, 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, 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, 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), New Delhi 2. Clinical Research Unit, Kerala. 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 MAWAHEED |
Clinical Research Unit |
Research OPD Room,Warm-e-Halaq (Pharyngitis), Edathala North P.O, Aluva
Kannur
KERALA |
7356589599
mawaheed313@gmail.com |
| Dr Abdul Raheem |
Regional Institute of Unani Medicine |
Research OPD Room,Warm-e-Halaq (Pharyngitis), D-11, Abul Fazal Enclave, Jamia Nagar, Okhla
New Delhi
DELHI |
9810919345
drabdulraheemccrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Kerala |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J312||Chronic pharyngitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Khardal |
500 mg (two tablets of 250mg) to be taken orally with water twice daily one hour after meals for 14 days.
|
| 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 years.
2. Patients having
Sore throat
Pharyngeal Inflammation along with any of these
Cough
Rhinorrhoea
Hoarseness
Oral ulcers
Conjunctivitis |
|
| ExclusionCriteria |
| Details |
1. Age below 18 and more than 60.
2. Patient with GERD.
3. Patient having bacterial pharyngitis.
4. Fever more than 100 F
5. Weak debilitating patients
6. Known cases of other clinically significant co-morbid conditions (severe hepatitis, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
7. Patients with laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator
8. Known hypersensitivity to study drug or any of its ingredients.
9. Pregnancy and lactation
10. Any Malignancy
11. History of alcohol and drug abuse. |
|
|
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 drug will be assessed on the basis Sore throat questionnaire |
At baseline, 14th day and 21 day of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline and after 14days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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 Warm-e-Halaq (Pharyngitis). 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 14days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.The treatment of waram-e-halaq
has been described in Unani system of medicine. There are so many Mufrad
(single) as well as Murakkab (Compound) Unani formulations mentioned in
classical texts which have been used in the treatment of waram-e-halaq by eminent Unani Physicians since ages and are known for their
efficacy and safety, but they need to be validated on scientific parameters in
order to generate data regarding their safety and efficacy.
Habb-e-khardal is an Unani
Pharmacopoeial Formulation widely used by Unani physicians to relieve symptoms
of waram-e-halaq(Pharyngitis).
Therefore, the present clinical study has been planned to scientifically
validate the efficacy and safety of Habb-e-khardal in the treatment of
especially in waram-e-halaq(Pharyngitis).
Composition of HABB -E -KHARDAL
| S. No. | Ingredients | Scientific Name | Quantity | Ratio proportion | | 1. | Filfil Siyah | Piper nigrum Linn | 10g | 1 | | 2. | Khardal biryan | Brassica nigra | 10g | 1 | | 3. | Kundur | Boswellia serrata Roxb | 60g | 6 | | 4. | Mur Makki | Commiphora myrrha Engl. | 60g | 6 | |