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CTRI Number  CTRI/2024/08/072426 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy and Safety of a Unani Formulation in the management of Gouty Arthritis 
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy and Safety of a Unani Formulation in the management of Niqris(Gouty Arthritis) : A Randomized 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  FARHA LUQMAN 
Designation  PG SCHOLAR 
Affiliation  State Takmeel-ut-Tib College and Hospital 
Address  Dept. of Moalajat Stat,e Takmeel-ut-Tib College and Hospital Near Ramabai Raily Sthal Binor Road Aurangabad Tiraha Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  8115026606  
Fax    
Email  farhaluqman72958@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Zubair 
Designation  Assisstant Professor 
Affiliation  Stat,e Takmeel-ut-Tib College and Hospital 
Address  Dept. of Moalajat State Takmeel-ut-Tib College and Hospital, Sthal Binor Road Aurangabad Tiraha Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  8318016554  
Fax    
Email  mzaligmd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Zubair 
Designation  Assisstant Professor 
Affiliation  Stat,e Takmeel-ut-Tib College and Hospital 
Address  Dept. of Moalajat State Takmeel-ut-Tib College and Hospital, Sthal Binor Road Aurangabad Tiraha Lucknow

Lucknow
UTTAR PRADESH
226002
India 
Phone  8318016554  
Fax    
Email  mzaligmd@gmail.com  
 
Source of Monetary or Material Support  
State Takmeel-ut-Tib College and Hospital Near ramabai raily sthal, Bijnor road, aurangabad tiraha lucknow 226002 
 
Primary Sponsor  
Name  FARHA LUQMAN 
Address  Department of Moalajat State Takmeel-ut-Tib College and Hospital, Near Ramabai Raily Sthal Binor Road Aurangabad Tiraha Lucknow 226002 
Type of Sponsor  Other [self] 
 
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 FARHA LUQMAN  STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL  DEPARTMENT OF MOALIJAT ROOM NUMBER 102 OPD BUILDING NEAR RAMABAI STHAL BIJNOR ROAD AURANGABAD TIRAHA LUCKNOW 226002
Lucknow
UTTAR PRADESH 
8115026606

farhaluqman72958@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL ,INSTITUTIONAL ETHICAL COMMMITTEE FOR BIOMEDICAL RESEARCH  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 
Comparator Agent  Febuxostat  Febuxostat, Dosage form: Tablet, Dose: 40 mg once daily, Duration. 60 days Route of administration: Oral 
Intervention  Polyherbal unani formulation of, Suranjan sheerin(colchicum luteum),3.5 gram Zanjabeel khushk(zinjiber officinalis), 3.5 gram Sibr(aloe barbadensis), 7 gram  Dosage form: Safuf (powder) Dose: 7 gram twice daily. Duration. 60 days Route of administration: Oral Polyherbal Unani formulation; Suranjan sheerin(colchicum luteum),3.5 gram Zanjabeel khushk(zinjiber officinalis), 3.5 gram Sibr(aloe barbadensis), 7 gram  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Clinically diagnosed patient of Gout with raised Serum uric acid level beyond normal limit
Both sexes
Clinically stable Patient 
 
ExclusionCriteria 
Details  Patient below 20 and above 65 years.
Gout with Diabetic Mellitus.
Pregnant women and lactating mother.
Severe illnesses of debilitated patients of cardiovascular system ,respiratory system, severe
renal or hepatic insufficiency, gastro- intestinal problems, nervous system and malignant
growth.
Any other type of arthritis such as Rheumatoid Arthritis, Osteoarthritis etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Response to treatment will be assessed using the following parameter
1-Reduction in uric acid
2-Reduction in C. Reaction
3-Improvement in Patients Global Assessement (PGA) based on VAS 
2week
4 week
6 week
8 week 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effect
kidney function test
liver function test
haemoglobin 
8 week 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   29/08/2024 
Date of Study Completion (India) 31/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Niqris (Gout) is the most common inflammatory arthritis worldwide. The prevalence of
Niqris gout ranged 1–4% worldwide and incidence ranged 0.1–0.3%. Gout incidence and
prevalence increases by each decade of life.
Gout is more common in men vs. women by 3:1 to 10: 1. . In men the reported prevalence
ranges from 7% in those aged over 75. It is rare in premenopausal women but increases to
2.5 – 3.0% in those aged over 75. 
The cases of Niqris (gout) increasing day by day due to increased prevalence of obesity,
poor life style and metabolic syndrome of which hyperuricemia is an integral component.
Serum uric acid (SUA) is the end product of purine metabolism. In most cases (5 – 25%)
excess of SUA or hyperuricemia occurs due to impaired renal urate excretion. While other
develop hyperuricemia due to over production of uric acid.
In Modern Medicine, drugs like NSAIDs, Colchicine, Gluco-corticoids, Probenecids, XO
inhibitors (Allopurinol and Febuxostat) are being used for the treatment of the gout. XO
inhibitors impede the synthesis of uric acid and are used for lowering the blood uric acid
level. XO inhibitor like Febuxostat and Allopurinol are the drug of choice for gout. 
Oral colchicine, NSAIDs along with intra-articular injection of soluble steroids are used to
suppress the attack of acute gout. Both colchicine and NSAIDS may be poorly tolerated
and dangerous in the elderly and in the presence of renal insufficiency and gastrointestinal
disorder. . XO have side effects of causing stomach ulcers, GIT bleeding, kidney and liver
damage etc.
Herbal remedies have been popular since antiquity of being relatively less expensive and
believed to be free of adverse effects. The unani drugs have proven its own importance
regarding its affectivity cost and minimal side effects.
In unani classical literature, for the treatment of various types of arthritis, a number of
treatment modalities like use of single and compound drugs such as Sooranjan sheerin
(Colchium luteum), Zaravand (A.longa & rotunda), Sibr (Aloe indicum), Haleela zard
(Terminalia chebula), Bozidan (Pyrethrum indicum), Zanjabeel khushk (Zingiber
officinalis) and Safuf Chobchini, Habbe Sooranjan etc. as well as Regimental Therapies
like Fasd, Hijama and Irsale alaq have been mentioned, which have potential role in
treating the disease on the basis of their Munzij (concoctive) Mushil (purgative), Mudir
(Diuretic), and Muarrik (diaphoretic) property by the evacuation of morbid matter.
So keeping all these therapeutic aspects in mind, some potent unani drug like Bozidaan
(Pyrethrum indicum), Khare khasak khurd (Tribulus terestris), Chobchini (Smilax china),
Aftimoon (Cuscuta reflexa), Muqil azrak (Commiphora mukul) which poses Mohallil
awram (Anti-inflammatory),  Mudir-e bowl (diuretic), Mulattif (demulcent), Mushil e
safra, Mushil e balgham (Purgative) and Munzij-e balgham wo sauda (concoctive) property
 have been chosen for the study. Though these drugs are being used for the treatment of
Niqris (gout) since long, but their efficacy and safety are not scientifically proved yet.Therefore viewing the above fact it has been planned to conduct a clinical trial to evaluate
the efficacy and safety of these drugs in gout on scientific parameters with the title: “A
Clinical Study to Evaluate the Efficacy and Safety of Unani formulation in the
Management of Niqris (Gouty Arthritis): A Randomized Controlled Clinical Trial.
 
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