| 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
|
|
|
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
|
|
|
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 “Anquroos†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. |