| CTRI Number |
CTRI/2025/12/099595 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Cervical Spondylosis in Unani Medicine |
|
Scientific Title of Study
|
A Randomized Clinical Trial to Evaluate the Efficacy of Hijama Bila Shart and Cervical Traction in the Management of Waja Ur Raqaba 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 |
Syed Jarrar Ahmad |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj Bit Tadabeer State Unani Medical College and Hospital Himmat Ganj Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
6392403619 |
| Fax |
|
| Email |
zarrarahmad14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohd Tausif |
| Designation |
Assisstant Professor |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj Bit Tadabeer State Unani Medical College and Hospital Himmat Ganj Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
6392403619 |
| Fax |
|
| Email |
mohdtausif328@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Jarrar Ahmad |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj Bit Tadabeer State Unani Medical College and Hospital Himmat Ganj Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
6392403619 |
| Fax |
|
| Email |
zarrarahmad14@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital Himmat Ganj Prayagraj-211016 U.P |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and Hospital Himmat Ganj Prayagraj |
| Address |
Department of Ilaj Bit Tadabeer State Unani Medical College and Hospital Himmat Ganj Prayagraj-211016 U.P |
| 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 |
| Syed Jarrar Ahmad |
State Unani Medical College and Hospital Prayagraj |
Department of Ilaj Bit Tadabeer State Unani Medical College and Hospital Himmat Ganj Prayagraj
Allahabad
UTTAR PRADESH |
06392403619
zarrarahmad14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Commtiee |
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 |
| Comparator Agent |
Cervical Traction |
C1 C7 Cervical Spine
Duration of Intervention 10 Minutes in Each Sitting
Traction Force 10 to 15 Percent of Body Weight
7 kg From Day 1 to Day 14
9 kg From Day 15 to Day 28 and Supine Position With Neck Flexed 15 to 20 degrees and Number of sitting Total 14 and Sittings Will be Given on Alternate Days and Duration of Assesment will be 28 day |
| Intervention |
Hijama Bila Shart |
For the Purpose of Hijama Bila Shart the Affected Area Should be Kept Uncovered and the Patient Should be
Kept in the Prone Position
Two Number Medium Size Cup
Two Cups Applied at the Cervical Spine from Base of the Skull to the Seven Cervical Vertebra and Two Cups Applied Laterally Over the right and left suprascapular region over lateral side of spine on Trapezius muscle ten minutes in each sitting
Number of Sitting Total 14 Sittings Will be Given on Alternate days and Duration of Assesment will be 28 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and Radiologically Diagnosed Patients of Waja ur Raqaba Cervical spondylosis With
Kellgren Lawerence Grading Scale Mild to Moderate Cervical Spondylosis
Willing to Give Informed Consent and Ready to Comply With Protocol |
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating mothers
Psychiatric Patients
History of Rheumatoid Arthritis
Previous History of Neck Trauma Cervical Fracture Surgery History of Congenital Spinal Abnormality
Spinal Tumor and Cancer Uncontrolled Diabetes Mellitus CAD Epilepsy Prosthesis Example Metal Rods Screw etc
Patient Taking Analgesic Steroidal Medicine With Washout Period For Topical Drugs Three Days and For Systemic Drugs Seven Days |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stiffness
Range of Motion Normal Cervical Flexion of Neck |
At Baseline 14 Day and 28 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Northwick Park Neck Pain Questionnaire
Short form 36 Questionnaire. |
At Baseline 14 Day and 28 Day
At Baseline 14 Day and 28 Day
At Baseline 14 Day and 28 Day |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
31/12/2025 |
| 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="0"
Months="0"
Days="28" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [zarrarahmad14@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 31-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cervical spondylosis refers to age related wear and tear affecting cervical intervertebral disc and vertebral bodies often leading to disc herniation and osteophyte formation these degenerative changes can lead to compression of spinal cord or nerve roots resulting in clinical symptoms Cervical spondylosis Waja ur Raqaba is a chronic degenerative process of the vertebral column characterized by pain in neck degenerative changes in intervertebral disc and osteophyte formation Most common degenerative changes are seen in C5 C6 followed byC6 C7 and C4 C5 |