| CTRI Number |
CTRI/2025/08/092459 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of patients suffering with chronic gout with Unani Medicine Habb-e-Leemun |
|
Scientific Title of Study
|
Clinical Validation Study of Unani Pharmacopoeial Formulation Habb -e- Leemun in Niqris (Chronic Gout) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NM/CG/HL/CLNVAL/CCRUM/23-24,version 01, |
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, 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 India
South West
DELHI
110058
India |
| Phone |
9811810454 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
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 India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : Regional Research Institute of Unani Medicine, 1, West Meda Church Street, Royapuram, Chennai – 600013 (Tamil Nadu) |
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Regional Research Institute of Unani Medicine (RRIUM), University of Kashmir Campus, Hazrat Bal, Srinagar – 190006 (Jammu &Kashmir)
|
|
|
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 Arjumand Shah |
Regional Research Institute of Unani Medicine |
Research OPD Room Niqris (Gout), University of Kashmir Campus, Hazrat Bal,
Srinagar – 190006
Srinagar
JAMMU & KASHMIR |
7006180746
dr.arjumandshah111@gmail.com |
| Dr Shaheen Akhlaq |
Regional Research Institute of Unani Medicine |
Research OPD Room Niqris (Gout),1, West Meda Church Street, Royapuram, Chennai – 600013
Chennai
TAMIL NADU |
9891868146
shazy123654@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Chennai |
Approved |
| Regional Research Institute of Unani Medicine, Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M1A||Chronic gout, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Leemun
|
One tablet Taken orally twice a day after meals with water for 6 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Conformed diagnosis of gout meeting ACR criteria (American College of Rheumatology Criteria) for gout.
2. History of recurrent gout flares (more than 2 per year).
3. Persistent symptoms such as joint pain, swelling, or tophi (visible urate deposits) present for at least six months.
4. Chronic hyperuricemia (serum uric acid equal or more than 6.8). |
|
| ExclusionCriteria |
| Details |
1. Known cases of joints diseases (Osteoarthritis, Osteomyelitis, Rheumatoid Arthritis) except Gout.
2. Patients with systemic diseases like Diabetes Mellitus, Hypertension, and Cardiovascular diseases.
3. Grade-2 obesity (BMI more than 35).
4. Hepatic and renal insufficiency and any malignancy.
5. Patient on long term medication.
6. Patients on drugs that increase uric acid levels. (Thiazide diuretics) or decrease calcium levels (furosemide).
7. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of the Habb -e- Leemun in the treatment of Niqris (Chronic Gout) will be carried out on the basis of Pain (VAS-Visual Analogue Scale) and Gout Assessment Questionnaire. |
At baseline, at first follow up and at the end of treatment. i.e., 0, 2nd, 6th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haematological and biochemical investigations for safety assessment i.e., Hemogram, LFT, KFT,Serum Uric acid, HbA1c, CRP and Urine Examination: Routine & Microscopic.
|
At baseline, at first follow up and at the end of treatment. i.e., 0, 2nd, 6th weeks |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
11/08/2025 |
| 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
|
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 Niqris (Chronic Gout). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. Efficacy and safety parameters will be assessed clinically and recorded every two weeks. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 6 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
The ingredients of the Habb-e-Leemun.
| S. No. | Ingredients | Scientific Name | Quantity | | 1. 1. | Post Illaichi kalan (Soktha) | Elettaria cardamomum | 25 gm | | 2. 2. | Post Halila Zard | Terminalia Chebula | 50 gm | | 3. 3. | Chhaliya Sokhta | Acacia Catechu Wild (Fruit) | 25gm | | 4. 4. | Habbul Neel (Kala dana) | Indigofera Tinctoria | 25gm | | 5. 5. | Kath Safaid | Acacia Catechu Wild (Extract) | 25gm | | 6. 6. | Murdar Sang | Triplumbic Tetroxide | 50gm | | 7. 7. | Aab-e-Leemu | Citrus Limon | 150ml |
|