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CTRI Number  CTRI/2023/07/054941 [Registered on: 07/07/2023] Trial Registered Prospectively
Last Modified On: 07/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Comparative clinical study on the effect of wet cupping and TENS in cervical spondylosis 
Scientific Title of Study   A Comparative clinical study on the effect of Hijamah- bil- Shart (wet cupping) and TENS in 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  Farheen Khanam 
Designation  Post graduate Scholar 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Ilaj Bit Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  7278435559  
Fax    
Email  khanamfarheen077@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nusrat Parveen 
Designation  Reader 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Ilaj Bit Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  7906813040  
Fax    
Email  nusratparveen12755@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bushra Aftab 
Designation  Reader 
Affiliation  State Unani Medical College and Hospital 
Address  Department of Ilaj Bit Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  8279747882  
Fax    
Email  drbushraaftab@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College old GT road himmatganj Prayagraj, Uttar Pradesh 211001 
 
Primary Sponsor  
Name  State Unani Medical College, himmatganj Prayagraj 
Address  Department of Ilaj -Bit- Tadbeer (IBT) State Unani Medical College, himmatganj Prayagraj,211016 India 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Farheen Khanam  State Unani Medical College and HAHRDM Hospital Prayagraj  OPD/IPD Of Ilaj-Bit-Tadbeer (IBT) SUMC Prayagraj 211016
Allahabad
UTTAR PRADESH 		 7278435559

Khanamfarheen077@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee state unani medical college , Prayagraj  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M479||Spondylosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hijamah- bil- Shart (wet cupping)   Size of cups : 4 medium (5.5 cm diameter) Location : Medium size cup- 2 on Kahil (Interscapular region), 2 on Mankibain (Suprascapular region) on weekly basis with 4 sittings.  
Comparator Agent  Transcutaneous Electrical Nerve Stimulation (TENS)  SITE : Paravertebral region (Cervical ) Intensity : 12-30 milliamps Frequency : 100-150 Hz Duration of procedure : 20 min, on Alternate day for study period of 21 days.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Willing to participate in the study
2. Both genders
3. Age between 20 – 60 years
4. Clinically and radiologically diagnosed patients of Waja-ul-Raqaba (Cervical spondylosis)
5. Body mass index (BMI) <_ 39 kg/m2
6. No apparent spinal deformity like- Kyphosis, scoliosis, Lordosis etc
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Wet cupping is effective in cervical Spondylosis
 		 0,7,14,21 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS)

Northwick Park Neck Pain Questionnaire (NPQ)
 		 at Base line, 21th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   20/07/2023 
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)
Modification(s)  		 Not Applicable 
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 - 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 - Informed Consent Form
    Response - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  On request

  6. For how long will this data be available start date provided 31-03-2025 and end date provided 07-08-2028?
    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
Modification(s)  

Cervical spondylosis (Waja-ur-Raqaba) is a chronic degenerative process of the vetebral column characterized by pain in neck, degenerative changes in intervertebral disc and osteophyte formation. About 10 million persons per year affected in India alone. The incidence of neck pain in adults is 25-50% per year . Prevalence of Cervical Spondylosis is similar in both sexes although degree of severities greater in males. It is most common spine disfunction in elderly people , the highest prevalence is in the age group from 45 to 60 yrs old . The associated factor is engaging in mental work,high housework intensity and raising trend in young age group using laptop, smartphone, sedentary habit, poor body posture is  factors for causing cervical spondylosis.As far as the treatment of Waja-ur-raqaba is concerned, since ancient times Unani physicians treatead this ailment successfully with various drugs & regimens including Hijamah- bil -shart, Dalk, Riyazat , Takmeed,Nutool etc. Among them Hijamah- bil- shart is one which is cmmonly prescribed to evacuate Mawad-e-fasida  and to provide relief to the patient of Waja-ul-Mafasil. Hence, keeping the above view in mind I have decided to conduct a comparative study entitled as “A Comparative clinical study on effects of Hijamah- bil- shart (wet cupping) and TENS in Waja-ur-Raqaba (Cervical spondylosis).

 
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