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CTRI Number  CTRI/2023/09/057624 [Registered on: 14/09/2023] Trial Registered Prospectively
Last Modified On: 12/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Irsal-e-Alaq (Leech Therapy) in Management of Niqris (Gout)  
Scientific Title of Study   Clinical Evaluation of the Effect of Irsal-e-Alaq (Leech Therapy) 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  SHAZIYA BEGUM 
Designation  Pg Scholar 
Affiliation  Aligarh Muslim University 
Address  Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  9958320742  
Fax    
Email  shaziasehar2012@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammad Shoaib 
Designation  Assistant Professor 
Affiliation  Aligarh Muslim University 
Address  Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  9411491568  
Fax    
Email  drmshoaib77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SHAZIYA BEGUM 
Designation  Pg Scholar 
Affiliation  Aligarh Muslim University, Aligarh 
Address  Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  9958320742  
Fax    
Email  shaziasehar2012@gmail.com  
 
Source of Monetary or Material Support  
Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University 
 
Primary Sponsor  
Name  Aligarh Muslim University 
Address  Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Shaziya Begum  Department of Ilaj Bit Tadbeer  Room No. 4 (Leech Therapy Unit) Ajmal Khan Tibbiya College and Hospital, Faculty of Unani Medicine, Aligarh Muslim University
Aligarh
UTTAR PRADESH 
9958320742

shaziasehar2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Faculty of Unani Medicine, Ajmal Khan Tibbiya College, Aligarh Muslim University, Aligarh  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  Habb-e-Suranjan two Tablets twice daily  Habb-e-Suranjan two tablets twice daily given orally for 4 weeks 
Intervention  Leech Therapy along with Habb-e-Suranjan 2 tablets twice daily  4-6 Leeches will be applied on the affected joint for 30 minutes twice weekly for 4 weeks along with two Tablets Habb-e-Suranjan twice daily given orally. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed cases of Gout
Patients willing to give informed written consent 
 
ExclusionCriteria 
Details  Patients below the age of 25 and above the age of 65 years
Patients with uncontrolled Diabetes Mellitus & Hypertension
Pregnant and lactating patients
Patients with systemic disorders like Chronic Renal Failure & Coronary Artery Disease
Diagnosed cases of Osteoarthritis and Rheumatoid Arthritis
Patients having malignancy, psychological disorder
Patients taking Pyrazinamide
Immunocompromised patients
Patients of bleeding disorders, severe anaemia, hypotension.
Patients having allergy to leech
Patients who refuse to sign the consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
VAS
Serum uric acid level 
Assessment on
Baseline
14th day
28th day  
 
Secondary Outcome  
Outcome  TimePoints 
Gout Impact Scale
Tenderness
Stiffness
Swelling
Redness
Temperature of affected joint
Restriction of movement 
Assessment on
Baseline
14th day
28th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   22/09/2023 
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  

 

Niqris originated from the Greek word â€œAnquroos” which means big toe (the first metatarsophalangeal joint). This is the classical site for the beginning of this disease, hence the disease got this name. Renowned Unani scholars Ibn-e-Sina, Majoosi, Jurjani, Antaki described that Madda-e-Niqrisiya (Morbid matter) accumulated in intra-articular space especially in big toe cause pain and inflammation. 


In modern system of medicine this disease is called ‘GOUT’. Gout is common inflammatory condition of joint. It is caused by deposition of monosodium urate crystals within the joints after chronic hyperuricemia. Prevalence of hyperuricemia varies according to the age, sex, race, geographical conditions and association with other diseases. It becomes common with increasing age: it is <0.5% in men under the age of 35 years and >7% in those aged over 75 years. It is rare in premenopausal women and increases to 2.5%-3.5% in those aged 75 years of age.


Irsal-e-Alaq is an ancient regimen of Ilaj-bit-Tadbeer used for diversion and evacuation of Akhlat-e-Fasida (morbid matter) by application of Leech on the affected parts of the body surface. Blood letting in the form of leech therapy has been utilised for preventive as well as curative measures for thousands of years by ancient Unani scholars.

 

Habb-e-Suranjan is the most common Unani medicine that is used in joints pain. It has anti inflammatory and analgesic actions. 


In Conventional system of medicine there is no permanent cure for Gout, only symptomatic treatment is available with analgesics and NSAIDs like Indomethacin and Urate lowering drugs like Allopurinol, Probenecid, Febuxostat etc.These drugs have many side effects. 


In Unani System of Medicine many single/ compound drugs like Zanjabeel, Muqil, Darchini, Majoon Chobchini, Habb-e-Suranjan, Habb-e-Asgand etc with regimenal procedures like Hijamah-bish-Shurt (wet cupping), Irsal-e-Alaq etc. are prescribed to treat gout with minimal/no side effects. Leech saliva has several bioactive substances that are anti-inflammatory, anticoagulant, vasodilator, anaesthetic etc. Leech therapy has no adverse effect in comparison to conventional medicine. The antiiflammatory and analgesic properties of leech saliva will be helpful in treating the painful condition of joints. Therefore, it is proposed to evaluate the efficacy of leech therapy in the management of Gout.

 

 

 
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