| CTRI Number |
CTRI/2024/10/076074 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [OPEN LABELED CLINICAL STUDY] |
| Study Design |
Other |
|
Public Title of Study
|
To see the effect of wet cupping on Gouty Arthritis across various Temperaments |
|
Scientific Title of Study
|
To Study The Effects Of Hijama Bil Shurt (Wet Cupping) In Gouty Aathritis In Patients Of Diffrent Temperaments |
| 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 Fahad Ullah |
| Designation |
PG Scholar |
| Affiliation |
Govt Nizamia Tibbi College Charminar Hyderabad |
| Address |
OPD Room no 6 Department of Kulliyat Govt Nizamia general hospital charminar Hyderabad
OPD Room no 6 Department of Kulliyat Govt Nizamia general hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
8299003933 |
| Fax |
|
| Email |
fahad.ullah4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MOHD YOUSUFUDDIN |
| Designation |
HOD DEPARTMENT OF KULLIYAT |
| Affiliation |
GOVT NIZAMIA TIBBI COLLEGE |
| Address |
OPD 6 GOVT NIZAMIA GENERAL HOSPITAL CHARMINAR HYDERABAD
OPD 6 GOVT NIZAMIA GENERAL HOSPITAL CHARMINAR HYDERABAD
Hyderabad
TELANGANA
500002
India |
| Phone |
9912904786 |
| Fax |
|
| Email |
yousufmohd96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fahad Ullah |
| Designation |
PG Scholar |
| Affiliation |
Govt Nizamia Tibbi College Charminar Hyderabad |
| Address |
OPD Room no 6 Department of Kulliyat Govt Nizamia general hospital charminar Hyderabad
OPD Room no 6 Department of Kulliyat Govt Nizamia general hospital charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
8299003933 |
| Fax |
|
| Email |
fahad.ullah4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Nizamia Tibbi College Charminar Hyderabad |
|
|
Primary Sponsor
|
| Name |
PG Department of Kulliyat E Tib Govt nizamia tibbi college charminar Hyderabad |
| Address |
OPD Room no 6 Department of Kulliyat E Tib (Principles of Medicines) Govt Nizamia general hospital charminar Hyderabad |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| FAHAD ULLAH |
GOVT NIZAMIA TIBBI COLLEGE |
OPD 6 GOVT NIZAMIA GENERAL HOSPITAL HYDERABAD
Hyderabad
TELANGANA |
08299003933
fahad.ullah4@gmail.com |
| Dr Fahad Ullah |
Govt Nizamia Tibbi College Charminar Hyderabad |
OPD Room no 6 Department of Kulliyat (Principle of Medicines ) Govt Nizamia general hospital charminar Hyderabad
Hyderabad
TELANGANA |
08299003933
fahad.ullah4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTA-ARISHTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Hijama bil Shurt (Wet cupping) | (Procedure Reference: Ghina Muna, Al Qanoon fil Tib ,Zakhira khwazam shahi, Akseerul Quloob, Procedure details: Hijama on Ankle joint, Knee joint, Gluteal region, Lumber region & Abdominal region in 3 sessions at intervals of 3 weeks)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 30 to 60 years
Sex Male and Female
Known case of Gouty Arthritis
Patients having sign and symtoms of Gouty Arthritis |
|
| ExclusionCriteria |
| Details |
Post-Operative Cases
Pregnant Women and lactating women
Patients with bleeding disorders or on
Anticoagulants
Patient of chronic heart disease
Tuberculosis
6. Different types of Anaemia
7. Uncontrolled diabetes
8. Below 30yr and above 60yr
9. patient with positive viral serology test
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in serum uric acid levels in participants after 9 weeks of treatment with Hijama bil shurt (Wet cupping). |
1.Baseline (day 0)
2.3rd week
3.6th week
4.9th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effects of Hijama bil shurt in condidion of pain & tenderness & swelling of joint & stifness of the joint in affected area in patients of various temperaments of Gouty arthritis. |
1.Baseline(day 0)
2.3rd week
3.6th week
4.9th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
12/11/2024 |
| 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="0"
Months="4"
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
|
Gouty arthritis is metabolic disease assosiated with overproduction of uric acid. This open labelled clinical trial aims to assess the effect of hijama bil shurt in gouty arthritis in the patients of diffrent temperaments. A total of 60 participants wiil undergo wet cupping for 9 weeks at intervals of every 3 weeks. The primery objective is to evaluate the impact of this therapy on serum uric acid levels in managing gouty arthritis. |