| CTRI Number |
CTRI/2025/05/086754 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of Hijama in Cervical Spondylosis |
|
Scientific Title of Study
|
Comparative evaluation of the effects
of Hijama bila Shart (Dry Cupping) &
Hijama bish shart (Wet Cupping) in
cases of Waja-al-Unuq (Cervical
Spondylosis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan Laiq |
| 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
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8630604317 |
| Fax |
|
| Email |
laiqmuskan@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
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9411491568 |
| Fax |
|
| Email |
drmshoaib77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muskan Laiq |
| 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
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8630604317 |
| Fax |
|
| Email |
laiqmuskan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ilaj Bit Tadbeer Ajmal Khan Tibbiya College and Hospital Aligarh Muslim
University Aligarh Uttar Pradesh India 202002 |
|
|
Primary Sponsor
|
| Name |
Department of Ilaj Bit Tadbeer |
| Address |
Ajmal Khan Tibbiya College, Faculty of Unani Medicine, Aligarh
Muslim University, Aligarh, Uttar Pradesh, India 202002 |
| 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 Muskan Laiq |
Ajmal Khan Tibbiya College Hospital |
Department of Ilaj bit Tadbeer
Faculty of Unani Medicine Aligarh 202002 UTTAR PRADESH
Aligarh
UTTAR PRADESH |
8630604317
laiqmuskan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Faculty of Unani Medicine, AMU, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
The effects of Hijama bila Shart (Dry Cupping)in cases of Waja-al-Unuq (Cervical
Spondylosis) |
Group A :•
The three cups will be placed one on Nuqra and two on Katifain (both shoulder) for 10 minutes weekly for 4 weeks.
•Neck Strengthening Exercise |
| Comparator Agent |
The effects of Hijama bish Shart (Wet Cupping)in cases of Waja-al-Unuq (Cervical Spondylosis) |
Group B:•
Apply at the junction of 7th cervical and 1st thoracic vertebra (Nuqra) & laterally over the right and left shoulder (Katifain)
After performing Hiajma bila shart (Dry Cupping) make incision
(15-20) on dry cupped area and sucked the blood up to 15-30 ml in each cup .
•Neck Strenghtening Exercise |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Clinically diagnosed patients of Waja’ al-Unuq (cervical spondylosis)
2)Patients who had given informed written consent and accepted to follow the protocol.
3)Patients of both genders.
4)Patients in the age group of 20-60 years.
5)Cervical spondylosis with or without radiculopathy. |
|
| ExclusionCriteria |
| Details |
1)Patients below 20 years and above 60 years.
2)Pregnant and lactating women.
3)Patients of diabetes and hypertension.
4)Patients with severe systemic illnesses.
5)Patients unable to give informed written consent.
6)Patient with nervous disorders like epilepsy & dizziness.
7)Patient having concomitant therapy.
8)Patient with thyroid disease.
9)Patient requiring rescue medicine very frequently or once a week. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•VAS (Visual Analogue Scale)[10]
•Vernon and Mior Cervical Spine Questionnaire
•X- ray cervical spine Antero-posterior and Lateral view |
7th, 14th, 21st, 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Pain
•Tenderness
•Range of motion
•Paraesthesia |
7th, 14th, 21st, 28th day |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| 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
|
Objective of the study: 1.)To evaluate the effects of Hijama bila Shart (Dry Cupping), in Waja-al Unuq (Cervical Spondylosis). 2.)To evaluate the effects of Hijama bish shart (Wet Cupping), in Waja-al Unuq (Cervical Spondylosis). 3.)To compare the effects of Hijama bila Shart (Dry Cupping) and Hijama bish shart (Wet Cupping), in Waja-al Unuq (Cervical Spondylosis). |