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CTRI Number  CTRI/2025/06/089716 [Registered on: 27/06/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to See Which Medicine Works Better in Gout Habbe Gul-e-Aak or Habbe Suranjan 
Scientific Title of Study   Efficacy and Safety of Habbe Gule Aak versus Habbe Suranjan in Primary Gout A Comparative Clinical Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR HELAL ANWER 
Designation  PG SCHOLAR Department of Moalajat 
Affiliation  GOVERNMENT TIBBI COLLEGE AND HOSPITAL 
Address  ROOM 403 4th floor PG BUILDING DEPARTMENT OF MOALAJAT GOVERNMENT TIBBI COLLEGE AND HOSPITAL KADAMKUAN PATNA 800003 BIHAR INDIA
IPD and OPD NO 29 DEPARTMENT OF MOALAJAT GTCH KADAM KUAN PATNA PIN CODE 800003 BIHAR INDIA
Patna
BIHAR
800003
India 
Phone  9852115633  
Fax    
Email  anwaralig91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MD NAJIBUR RAHMAN  
Designation  ASSOCIATE PROFESSOR CUM HOD 
Affiliation  GOVERNMENT TIBBI COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF MOALAJAT ROOM 402 4TH FLOOR PG BUILDING GOVERNMENT TIBBI COLLEGE AND HOSPITAL KADAMKUAN PATNA
IPD and OPD NO 29 DEPARTMENT OF MOALAJAT GTCH KADAM KUAN PATNA 800003 BIHAR
Patna
BIHAR
800003
India 
Phone  9122332101  
Fax    
Email  drmdnajibur.rahman@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR MD RAZI AHMAD 
Designation  ASSOCIATE PROFESSOR 
Affiliation  GOVERNMENT TIBBI COLLEGE AND HOSPITAL 
Address  Room no 409 4TH FLOOR DEPARTMENT OF MOALAJAT GOVERNMENT TIBBI COLLEGE AND HOSPITAL KADAMKUAN PATNA 800003 BIHAR
IPD and OPD NO 29 DEPARTMENT OF MOALAJAT GTCH KADAM KUAN PATNA 800003 BIHAR
Patna
BIHAR
800003
India 
Phone  7909035622  
Fax    
Email  dr.razi.ahmed91@gmail.com  
 
Source of Monetary or Material Support  
OPD ROOM NO 29 DEPARTMENT OF MOALAJAT Govt Tibbi College and Hospital BUDH MURTI KADAM KUAN Patna BIHAR INDIA 800003 OPDs  
 
Primary Sponsor  
Name  Govt Tibbi College And Hospital  
Address  Govt Tibbi College And Hospital BUDH MURTI Kadam Kuan Patna BIHAR PIN CODE 800003 INDIA 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR MD NAJIBUR RAHMAN  Govt Tibbi College And Hospital Patna  OPD Room Number 29 Department of Moalajat Government Tibbi College and Hospital Budh Murti Kadamkuan Patna pin code 800003 Patna BIHAR
Patna
BIHAR 		 9122332101

drmdnajibur.rahman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govt Tibbi College And Hospital Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M100||Idiopathic gout,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HABBE GULE AAK  HABBE GULE AAK Orally two pills(each 500 mg) twice a day after meal for 30 days 
Comparator Agent  HABBE SURANJAN  HABBE SURANJAN Orally two pills(each 500 mg) twice a day after meal for 30 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Diagnosed cases of primary gout
2.serum uric acid more than 7.2%
3.Patients of either gender
4.Patients between 30 to 65 years of age
Patients who have agreed to participate and sign the consent form 
 
ExclusionCriteria 
Details  1.Pregnancy and lactation
2.Complicated cases of Gout
3.Co-morbid conditions of participants like Diabetic Ketoacidosis, Nephropathy, Coronary artery disease, Peripheral vascular disease, cerebrovascular disease and liver disease.
4.Immuno-compromised states like Malignancies, AIDS and on Immuno-suppressive agents.
5.Participants fail to attend treatment schedule regularly
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of serum uric acid   at baseline i.e. 00th day(visit 1 ,7th day(visit 2), 14th day ( visit 3) and 30th day ( visit 4) 
 
Secondary Outcome  
Outcome  TimePoints 
Change in different clinical symptoms of primary gout  7th, 14th, 21st, and 30th days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/07/2025 
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="1"
Months="6"
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   After thorough screening, diagnosed patients of primary gout who fulfil inclusion criteria will be included in study. Patients will be included for the study. The patients will be randomly allocated in two groups 30 in test group (Habbe Gule Aak) and 30 in control group (Habbe Suranjan). Treatment will be given for 30 days in both groups. Objective Parameters will be assessed before and after treatment.  
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