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CTRI Number  CTRI/2025/07/091576 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani
Other (Specify) [CUPPING THERAPY]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of wet cupping (Hijama) on cervical spondylosis.  
Scientific Title of Study   Randomized Comparative Clinical Study to Evaluate the Efficacy and Safety of Hijama Bi’l Shart on the Sites of Mankib and Kahil in the Management of Cervical Spondylotic Radiculopathy 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yasmeen Shamsi 
Designation  Professor 
Affiliation  Jamia Hamdard University 
Address  Room no 104, First floor,Department of MOalajat, SUMER, Jamia Hamdard

New Delhi
DELHI
110062
India 
Phone  8750040776  
Fax    
Email  yshamsi@jamiahamdard.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Mariya Khan 
Designation  MD SCHOLAR 
Affiliation  Jamia Hamdard University 
Address  First Floor,Department of Moalajat, SUMER, Jamia Hamdard

New Delhi
DELHI
110062
India 
Phone  7701849171  
Fax    
Email  me.mariyakhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yasmeen Shamsi 
Designation  Professor 
Affiliation  Jamia Hamdard University 
Address  Room no 104, First floor,Department of MOalajat, SUMER, Jamia Hamdard

New Delhi
DELHI
110062
India 
Phone  8750040776  
Fax    
Email  yshamsi@jamiahamdard.ac.in  
 
Source of Monetary or Material Support  
Jamia Hamdard, Mehrauli Badarpur road, Hamdard nagar, New delhi, 110062, India 
 
Primary Sponsor  
Name  JAMIA HAMDARD University Moalajat dept 
Address  Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062.  
Type of Sponsor  Other [university] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Yasmeen Shamsi  Majeedia Unani Hospital  Moalajat opd and ipd
South
DELHI 		 8750040776

yshamsi@jamiahamdard.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Jamia Hamdard Institutional Ethics Committee   Approved 
Jamia Hamdard Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M953||Acquired deformity of neck, (2) ICD-10 Condition: M488||Other specified spondylopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group 1  Hijama therapy (wet cupping) on site of KAHIL will be carried out for 8 weeks (0 day, 14th day,28th day,42nd day,56th and 70th day). 
Intervention  Group 2  Hijama therapy (wet cupping) on site of MANKIB will be carried out for 8 weeks (0 day, 14th day,28th day,42nd day,56th and 70th day). 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of cervical spondylosis in the age-group of 30-60 years.
2.Patients of all genders
3.Patients with signs and symptoms of cervical spondylosis with radiculopathy and radiological evidences of cervical spondylosis in C3 TO C7
4.Cervical radiculopathy diagnosed by positive response to at least one of the four Upper Limb 5.Tension Tests with symptoms of cervical radiculopathy for less than 6 months
6.Pain intensity score of 30-60 mm on a 100-mm visual analog scale
7.Willingness to give informed consent
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women.
2.Any history of cardiac, hepatic, renal insufficiency.
3.History of spinal whiplash injury OR fracture.
4.History of any spinal surgery.
5.Patients taking NSAIDs or corticosteroids (washout period NSAIDs 01 week Corticosteroids 6 weeks).
6.Known cases of any other disease of cervical spine like Ankylosing spondylitis, any Vascular lesions and Neoplasms.
7.Patients taking any non-pharmacological therapy for the same complaint in the past 4 weeks. (eg. Acupuncture, Hijama, physiotherapy).
8.Patients of bleeding disorders/ anaemia (Hb lower than 9 gm ). Patients taking Anti-coagulants.
9.HIV/AIDS, HCV and HBsAg positive patients.
10.Patients with uncontrolled Diabetes mellitus (HbA1C more than 7 percent) and hypertension (Systolic more 129 mm Hg, Diastolic more than 89 mm Hg).
11.Alcoholic patients, tobacco users. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy and safety of Hijamah bil-Shart on the sites Mankib and Kahil in the treatment of cervical spodylotic radiculopathy.
To compare the effect of Hijamah bil Shart on the site Mankib with Hijamah bil Shart on Kahil in cervical radiculopathy.

 		 First evaluation on 0 day and the last will be on 70th day 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Hijamah bil Shart on quality of life in patients of cervical spondylotic radiculopathy.
 		 First evaluation on 0 day andthe last will be on 70th 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)   04/08/2025 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [me.mariyakhan@gmail.com].

  6. For how long will this data be available start date provided 15-07-2025 and end date provided 22-07-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Cervical spondylotic radiculopathy (CSR) is a clinical syndrome caused by cervical disc degeneration, hyperostosis, loosening of cervical joint and ligament, and stimulation or compression of cervical nerve roots.Owing to recent lifestyle changes, life and work stress the incidence of cervical spondylosis tends to increase year by year and it is now frequently detected in younger patients however, most patients are usually asymptomatic.  
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