| CTRI Number |
CTRI/2025/09/094505 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Unani drugs in gout |
|
Scientific Title of Study
|
Efficacy of Habb-e-Chobchini (Oral administration) and Dimad Muhallil (topical application) in Niqris (Gout)(NUMC: L-7; ICD: M10): A randomised single blind double dummy placebo controlled clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farooqui Shazia Parveen Barkat Ali |
| Designation |
Research Officer |
| Affiliation |
Regional Research Institute of Unani Medicine Chennai |
| Address |
Research OPD 10, Clinical Research Department, Regional research institute of Unani Medicine, Chennai no. 1 west madha road Royapuram Chennai
No 1 west mada church street Royapuram Chennai 600013
Chennai
TAMIL NADU
600013
India |
| Phone |
08147438868 |
| Fax |
|
| Email |
shaziafarooquinium@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Farooqui Shazia Parveen Barkat Ali |
| Designation |
Research Officer |
| Affiliation |
Regional Research Institute of Unani Medicine Chennai |
| Address |
Research OPD 10, Clinical Research Department, Regional research institute of Unani Medicine, Chennai no. 1 west madha road Royapuram Chennai
No 1 west mada church street Royapuram Chennai 600013
TAMIL NADU
600013
India |
| Phone |
08147438868 |
| Fax |
|
| Email |
shaziafarooquinium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farooqui Shazia Parveen Barkat Ali |
| Designation |
Research Officer |
| Affiliation |
Regional Research Institute of Unani Medicine Chennai |
| Address |
Research OPD 10, Clinical Research Department, Regional research institute of Unani Medicine, Chennai no. 1 west madha road Royapuram Chennai
No 1 west mada church street Royapuram Chennai 600013
TAMIL NADU
600013
India |
| Phone |
08147438868 |
| Fax |
|
| Email |
shaziafarooquinium@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine New Delhi |
| Address |
Jawaharlal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi 110058 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Farooqui Shazia Parveen Barkat Ali |
Regional Research Institute of Unani Medicine Chennai |
Research OPD 10, Clinical Research Department, Regional research institute of Unani Medicine, Chennai no. 1 west madha road Royapuram Chennai
Chennai
TAMIL NADU |
08147438868
shaziafarooquinium@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Regional Research Institute of Unani Medicine Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Chobchini and Dimad Muhallil |
Habb-e-Chobchini orally 500mg twice daily for 56 days and Dimad Muhallil topically once in a day for 56 days |
| Comparator Agent |
Placebo Dimad and Oral Placebo |
Placebo Dimad topical once in a dau for 56 days and oral placebo 500mg twice daily for 56 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18-65 years of any gender
Patients with uric acid level more than 7 mg/dl and less than 9.5 mg/dl
Patients having capacity and willingness to give consent and complete trial documentation
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 65 years
Patients who are known cases of Renal, Cardiac, Liver and Pulmonary diseases
Pregnant and Lactating females
Patient with uncontrolled Hypertension (SBP more than 140 mm Hg, DBP more than 90 mm Hg)
Patients with uncontrolled Diabetes Mellitus (RBS more than the normal range, in patients on Insulin therapy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| serum uric acid |
56 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters along with improvement in Quality of life
Reduction in CRP and ESR level from baseline to the end of the treatment |
56 days |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
21/09/2025 |
| 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 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
|
The clinical trial aims to evaluate the efficacy and safety of Habb-e-Chobchini taken orally and Dimad Muhallil applied topically for the treatment of Niqris or Gout. It is a randomized double blind double dummy placebo controlled study conducted at the Regional Research Institute of Unani Medicine Chennai. A total of 87 participants aged between 18 and 65 years with serum uric acid levels from 7 to 9.5 mg per dl will be enrolled. Patients with serious illnesses pregnancy recent surgery or known allergies to the trial drugs are excluded. The study duration is two years with treatment lasting eight weeks. Participants are divided into three groups. Group A receives Habb-e-Chobchini and placebo Dimad. Group B receives placebo oral and Dimad Muhallil. Group C receives both active Habb-e-Chobchini and Dimad Muhallil. Habb-e-Chobchini will be given as 500 mg twice daily and Dimad Muhallil as 10 grams twice daily. Clinical and laboratory follow ups will be on day 14 28 42 and 56. Safety will be monitored by blood tests including hemoglobin total leukocyte count ESR liver and kidney function tests and urine examination. Efficacy is assessed by reduction in serum uric acid CRP ESR and improvements in quality of life visual analogue scale and verbal rating scale. Data will be analyzed by paired t tests with significance at p less than 0.05. Withdrawal is allowed for adverse events non compliance or patient request. The trial also assesses the Unani concept of Mizaj temperament and ensures drug accountability. Informed consent will be obtained after explaining study procedures and risks. The primary goal is reduction of serum uric acid and the secondary goal is improving symptoms and quality of life. |