FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/098106 [Registered on: 26/11/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani
Other (Specify) [HIjama Therapy]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of Non specific low back pain. 
Scientific Title of Study   A Comparative Clinical Study on the Efficacy of Hijama Mutaharrika with Roghan-e-Narjeel and Hijama Bila-Shart in the Treatment of Waja’al-Zahr (Non-Specific Low Back Pain) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadiah Zia 
Designation  Pg Scholar 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Ilaj-bit-Tadbeer, State Unani Medical College and Hospital, Prayagraj, Uttar Pradesh

Allahabad
UTTAR PRADESH
211016
India 
Phone  7380791114  
Fax    
Email  sadiahziya30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  prof Nusrat Parveen 
Designation  Professor 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Ilaj-bit-Tadbeer, State Unani Medical College and Hospital, Prayagraj, Uttar Pradesh
Department of Ilaj-bit-Tadbeer, State Unani Medical College and Hospital, Prayagraj, Uttar Pradesh
Allahabad
UTTAR PRADESH
211016
India 
Phone  7906813040  
Fax    
Email  nusratparveen12755@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sadiah Zia 
Designation  Pg Scholar 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Ilaj-bit-Tadbeer, State Unani Medical College and Hospital, Prayagraj, Uttar Pradesh

Allahabad
UTTAR PRADESH
211016
India 
Phone  7380791114  
Fax    
Email  sadiahziya30@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College and Hospital, Prayagraj-211016 Uttar Pradesh, India 
 
Primary Sponsor  
Name  State Unani Medical College and Hospital 
Address  Old GT Road Himmatganj Prayagraj 211016, Uttar Pradesh 
Type of Sponsor  Government medical college 
 
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 
Sadiah Zia  State Unani Medical College  Department of Ilaj-bit-tadabeer, Old GTRoad, Himmatganj, Prayagraj-211016, Uttar Pradesh
Allahabad
UTTAR PRADESH 		 7380791114

sadiahziya30@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hijama Mutaharrika (Gliding Cupping)  Four cups sized 5.8 cm(post-gliding) will be used on the lumbosacral region. The intervention will be performed for 10 minutes per session, and 14 alternate-day sittings will be given over 4 weeks (28 days total). Clinical assessment will be conducted on day 0, day 14, and day 28. Procedure: The lumbosacral area will first be massaged with oil. A sterilized 5.8 cm cup will be placed, negative pressure will be created using a manual pump (half to one pull), and the cup will be glided over the area for 5 minutes. Thereafter, four cups will be placed stationary on the lumbosacral region and left for another 5 minutes. Finally, the cups will be removed using standard cupping techniques. 
Comparator Agent  Hijama-Bila-Shart (Dry Cupping)  Four sterilized disposable cups sized 5.8 cm will be used on the lumbosacral region. The intervention will be administered for 10 minutes per session, and 14 alternate-day sittings will be provided over 4 weeks (total duration of assessment: 28 days). Clinical assessment of the patient will be conducted on day 0, day 14, and day 28. Procedure: Sterilized disposable cups will be placed on the selected lumbosacral site. Mild to strong negative pressure will be created using a manual pump and adjusted according to the patient’s comfort. Four cups will be applied and left in place for 10 minutes. The patient will be continuously monitored for any discomfort or adverse reactions. For removal, the vacuum will be released, the cups will be gently lifted, and the area will be cleaned with sterile cotton or gauze. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group 20-60 years of both genders with mild to moderate cases.

No radiation of low back pain to other region.

No apparent spine deformity like Kyphosis, Scoliosis and Lordosis etc.

Clinically diagnosed patients of Waja’al-Zahr.

Patients willing to give written informed consent and comply with the protocol.
 
 
ExclusionCriteria 
Details  Pregnant and lactating women.

Any systemic and metabolic illness such as liver, cardiac, pulmonary diseases, Diabetes mellitus, hypertension or any mental illness.

Radiologically evident cases of spinal injury/deformity/disease, Prolapsed intervertebral disc, Spinal deformity (Congenital/Acquired), Low back pain secondary to a malignant or autoimmune
disease, Patients on analgesic, steroidal, and hormonal therapy.

Prosthetic device, Lumbar stabilization implant, etc.

Patient taking analgesic drug treatment and steriods in past one week.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Visual Analogue Scale.
Change in Oswestry Low Back Pain Questionnaire (ODI) 		 Change in Visual Analogue Scale assessed at baseline, 2nd weeks & 4th weeks.
Change in Oswestry Low Back Pain Questionnaire (ODI) assessed at baseline, 2nd week & 4th week.  
 
Secondary Outcome  
Outcome  TimePoints 
Change in SF36 questionnaire.  Change in SF36 questionnaire assessed at baseline & 4th weeks. 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   19/12/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sadiahziya30@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 30-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a randomized, open-label, parallel-group comparative clinical trial to evaluate and compare the efficacy of Hijama Mutaharrika (gliding cupping) with Roghan-e-Narjeel (virgin coconut oil) versus Hijama Bila-Shart (dry/static cupping) in sixty-eight patients aged 20–60 years suffering from mild to moderate non-specific low back pain (Waja’al-Zahr) without radiation or red-flag signs. Patients will be equally randomized into two groups, each receiving 14 alternate-day sessions of 10-minute cupping therapy over 4 weeks on the lumbosacral region. The primary outcomes are reduction in pain measured by Visual Analogue Scale (VAS) and improvement in disability assessed by Oswestry Disability Index (ODI), while the secondary outcome is quality of life measured by Short Form-36 (SF-36) questionnaire at baseline, 14th day, and 28th day. The study is being conducted as an academic MD dissertation at the Department of Ilaj-bit-Tadabeer, State Unani Medical College and Hospital, Prayagraj, Uttar Pradesh, India, under the supervision of Prof. Nusrat Parveen, with ethical clearance applied for and no external funding. 
Close