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CTRI Number  CTRI/2024/08/072000 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   A Study on Gout to evaluate the safety and efficacy of Polyherbal formultion. 
Scientific Title of Study   A single blind observational study to evaluate the safety and efficacy of polyherbal formulation in the management of Niqris (Gout). 
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 Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology, Awantipora, Pulwama.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1

Pulwama
JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology, Awantipora, Pulwama.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1


JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tabasum Fatima 
Designation  Research Associate 
Affiliation  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology, Awantipora, Pulwama.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1


JAMMU & KASHMIR
192122
India 
Phone  9419421375  
Fax    
Email  tabasumfatima281@gmail.com  
 
Source of Monetary or Material Support  
Islamic University of Science and Technology 
 
Primary Sponsor  
Name  Islamic University of Science and Technology 
Address  Islamic University of Science and Technology. Awantipora, Pulwama, 192212 
Type of Sponsor  Research institution and hospital 
 
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 Tabasum Fatima  AYUSH Health and Wellness Centre  Islamic University of Science and Technology.Department: Centre for AYUSH Sciences, Ayush healyh and wellness centre, OPD no:1
Pulwama
JAMMU & KASHMIR 
9419421375

tabasumfatima281@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Islamic University of Science and technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M109||Gout, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drugs namely Suranjan (ColchicumLuteum), Khulanjan (Alpinia Galanga) and Bozidan (Pyrethrum Indicum)  The drugs will be ground into fine powder then 5 grams of the drug will be given three times a day orally for 60 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either sex will be selected for the study.
2.Between 18 to 60 years of age.
3.Fulfilling the criteria of American College of Rheumatology for diagnosing Gouty Arthritis including clinical features, laboratory, and radiological finding will be included in the study, who had serum Uric Acid level more than 7mg/dl.
 
 
ExclusionCriteria 
Details  1.Patients below 18 and above 60 years of age.
2.Pregnant and Lactating mothers.
3.Patients who fail to give consent.
4.Patients of Gout associated with any systemic disorder which interfere with patient study will be excluded.
5.Patients of Gout associated with any severe Arthritis condition. Such as Rheumatoid arthritis, Septic arthritis will be excluded from the study
6.Patients suffering from Anemia and other blood dyscrasias like leukemia, hemophilia etc
7.Patients with history of suffering with congenital Gout.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Serum uric acid level.
2. CRP
3. ESR
 
2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
1 Pain Tenderness and Swelling in the affected joints
2 Difficulty in movement.
3 Affected joint redness (Erythema).
 
2 years 
 
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   N/A 
Date of First Enrollment (India)   15/08/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 16-06-2026 and end date provided 15-06-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Niqris (Gout) is one of the most common types of inflammatory jointdiseases creating difficulty and problems in day to day life. Itis characterized by recurrent attacks of acute pain and swelling primarily affecting one joint usually the metatarso-phalangeal joint of big toe and small joints of feet and hands, commonly affects both feet.The prevalence of Gout varies between population but is approximately 1-2% and out of the affected population males are more common while females of the postmenopausal group are at high risk. According to Hippocrates, it occurs rarely in children and premenopausal women and does not occur in transgenders. Six centuries later to Buqrat,  Jalinoos was the first to describe tophi. An excessive intake of food containing high purine contents (Baadi Ghiza) is the primary or essential cause of Gouty Arthritis (Niqris), which results in deposition of Maddah-e-Niqris (urates or tophi), in the articular and periarticular tissues.In modern medicine NSAID’s, Uricosuric drugs, colchicine, glucocorticoids etc. are used for subsiding acute attacks or lowering serum uric acid which is associated with potent adverse effects like vomiting, GI bleeding, hepato-renal toxicity, hypersensitivity etc. The side effects of all above-mentioned drugs call for the development of novel drugs or methods of treatment used with similar and better efficacy and lesser toxicity than presently available drugs.Now a days Unani system of Medicine is getting authentication for the treatment of such type of disease by its unique concept which is equilibrium of humors, for this purpose different methods of treatment are applied like Ilaj bil Giza (Dietotherapy), Ilaj bil Dawa (Pharmacotherapy) , Ilaj bil Tadbeer (Rehimenal Therapy), and Ilaj bil Yad (Surgery). The Unani medicines being having less side effects are more beneficial, thus the present study has been designed to study the efficacy and safety of the poly herbal formulation, constituting the drugs namely Suranjan (ColchicumLuteum), Khulanjan (Alpinia Galanga) and Bozidan (Pyrethrum Indicum)

Diagnostic Criteria: Patients with classical sign and symptom of Niqris (Gout) with uric acid level more than 7mg/dl.

 Study design: Single blind, observational study.Sample size: 30 patients

 Intervention.

 Test group: Powder of Suranjan, Khulanjan and Bozidan.

 Method of Prepration: The drugs will be grinded into fine powder and all will be mixed properly.

 Dosage: 5 gm of each drug ie a total of 15grams of drug will be given in three divided doses every day.

 Route of Administration:Oral

 Duration   of Protocol: 60 days with follow up as ( 15th, 30th,45th,60th)

 Duration of Study: 2 years

 Procedure of study:

Enrolled cases of Gout will be recruited after obtaining a written informed consent.

The pre and post treatment subjective and objective findings (effects) will be compared and its significance will be evaluated through a suitable statistical test.

 
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