| CTRI Number |
CTRI/2022/11/046982 [Registered on: 02/11/2022] Trial Registered Prospectively |
| Last Modified On: |
01/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Unani Modality (Wet Cupping) and its Efficacy in Musculoskeletal Pain Management |
| Study Design |
Other |
|
Public Title of Study
|
"Clinical and Haematological Study of Hijama Bil Shart(Wet Cupping) in the Management of Pain" |
|
Scientific Title of Study
|
"Clinical and Haematological Study of Hijama Bil Shart(Wet Cupping) in the Management of Pain |
| Trial Acronym |
CAHSOHBSWCITMOP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saif Ali Siddiqui |
| Designation |
PG Scholar |
| Affiliation |
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College, F/O Unani Medicine, AMU Aligarh. |
| Address |
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College, AMU Aligarh.
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College,AMU, Aligarh.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7668577414 |
| Fax |
|
| Email |
saifalig254@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Shoaib |
| Designation |
Assistant professor |
| Affiliation |
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College, F/O Unani Medicine, AMU Aligarh. |
| Address |
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College, F/O Unani Medicine, AMU Aligarh.
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College, F/O Unani Medicine, AMU, UP, INDIA
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9411491568 |
| Fax |
|
| Email |
drmshoaib77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saif Ali Siddiqui |
| Designation |
PG Scholar |
| Affiliation |
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College, F/O Unani Medicine, AMU Aligarh. |
| Address |
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College, AMU Aligarh.
Department of Ilaj bit Tadbeer, Ajmal Khan Tibbiya College, AMU Aligarh.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7668577414 |
| Fax |
|
| Email |
saifalig254@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALIGARH MUSLIM UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
Department of Ilaj Bit Tadbeer, Aligarh Muslim University, UP, INDIA |
| Address |
Department of Ilaj Bit Tadbeer, Aligarh Muslim University, UP, INDIA |
| Type of Sponsor |
Other [Faculty of Unani Medicine, Aligarh Muslim University] |
|
|
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 |
| Saif Ali Siddiqui |
Ajmal Khan Tibbiya College |
Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH |
7668577414
saifalig254@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (3) ICD-10 Condition: M498||Spondylopathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients complaining of pain
a) Integumental pain - such as clinically diagnosed case of Osteoarthritis, Rheumatoid Arthritis, Cervical and lumbar Spondylitis, Frozen shoulder etc. and
b) Neuropathic pain - Such as sciaeica
2. Patient who have agreed to sign the inform consent form and follow the protocol.
|
|
| ExclusionCriteria |
| Details |
1.Recent history of trauma or fracture of bone
2.Systemic diseases (e.g. Diabetes and Hypertension )
3.Angina/ MI pain
4.Pregnancy & Lactation
5.Patients having bleeding disorders
6.Patient on anti-coagulant and anti-platelet therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters (VAS- Visual Analogue Scale) |
1 month with every week follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in objective parameters (C- Reactive Protein and Serum Uric Acid) |
1 month with every week follow up. |
|
|
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)
|
05/11/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinical and Haematological study of Hijama Bil Shart(Wet Cupping) in the Management of Pain - An Open/Unblinded Observational Study.
Note: Due to some personal issue, I was unable to register at the time of first enrollment, so I am registering my clinical trial now. I kindly request you to approve my clinical trial registration, I will be highly obliged to you. |