| CTRI Number |
CTRI/2024/10/075885 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Hijama (Cupping) ] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Hijamah (wet cupping)in management of cervical spondylosis |
|
Scientific Title of Study
|
A Clinical Study Of Cervical Spondylosis (Waja Al Unuq) AND Its Management With Hijama Bil Shart(Wet Cupping) |
| 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 zubair Alam |
| Designation |
MD Scholar |
| Affiliation |
Govt nizamia tibbi college and hospital |
| Address |
D/O Moalijath, Room No. 213 First Floor Green Building, Govt. Nizamia Tibbi College, Charminar, Hyderabad, TG-500002
Hyderabad
TELANGANA
500002
India |
| Phone |
7013691785 |
| Fax |
|
| Email |
zalam95535@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Narsimha |
| Designation |
Professor |
| Affiliation |
Govt nizamia tibbi college and hospital |
| Address |
Room No 107 Ground Floor Green Building Govt. Nizamia Tibbi College Hyderabad TG-500002
Hyderabad
TELANGANA
500002
India |
| Phone |
9866985269 |
| Fax |
|
| Email |
dr.n.narasimha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Narsimha |
| Designation |
Professor |
| Affiliation |
Govt nizamia tibbi college and hospital |
| Address |
Room No 107 Ground Floor Green Building Govt. Nizamia Tibbi College Hyderabad TG-500002
Hyderabad
TELANGANA
500002
India |
| Phone |
9866985269 |
| Fax |
|
| Email |
dr.n.narasimha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College And Hospital Charminar Hyderabad,Telangana, India. 500002. |
|
|
Primary Sponsor
|
| Name |
Govt Nizamia Tibbi College |
| Address |
Govt nizamia tibbi college and hospital hyd, telangana |
| 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 Zubair Alam |
Government Nizamia Tibbi College And Hospital Charminar Hyderabad. |
Opd no:-107pg Department of Moalijat(General Medicine)Government Nizamia Tibbi College And Hospital Charminar Hyderabad.
Hyderabad
TELANGANA |
7013691785
zalam95535@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt.Nizamia Tibbi College, Charminar, Hyderabad,Telangana State. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijama Bil Shart(Wet Cupping) |
Hijama At Neck and Head,in 4 Sessions at 7days Interval. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptoms like
Pain
Swelling
Restricted neck movement and stiffness |
|
| ExclusionCriteria |
| Details |
Pregnancy and Lactation
Mentally retarded patients
Age below 18 years
Patient with bleeding tendencies
Uncontrolled DM |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain,Swelling,Stiffness,and Restricted Neck movements. |
Hijama At Neck and Head in 4 Sessions at 7days of Interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NPDA (Neck Pain And Disability Index) |
0 Day
7th Day
14th Day
21st Day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/11/2024 |
| 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="1"
Months="6"
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
|
Proposed open, randomised comparative study will be carried out on 30 patients of cervical spondylosis to be diagnosed clinically and radiologically. Patients fulfilling inclusion and exclusion criteria will be recruited and randomly selected.
3-4 sessions of Al-Hijamah will be done on day 0, day 7th , 14th and day 21st. There will be a 7 days therapy free period and last assessment will be done on day 21st. Assessment will be done on NPDA, Sign and symptoms. |
|