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CTRI Number  CTRI/2023/05/052585 [Registered on: 12/05/2023] Trial Registered Prospectively
Last Modified On: 12/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effects of Massage Cupping and Wet cupping therapy in Cervical spondylosis 
Scientific Title of Study   Comparative clinical trial of Hijamah Bila Shart (Massage cupping) and Hijamah Bi Shart (Wet cupping) in Cervical Spondylosis A randomized, open label, comparative efficacy trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arjumand shah 
Designation  Research officer 
Affiliation  Regional research Institute of Unani Medicine ,Srinagar(CCRUM Ministry of AYUSH) 
Address  Regional Research Institute of Unani medicine Srinagar Naseem Bagh ,Habak Crossing

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006180746  
Fax    
Email  dr.arjumandshah111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arjumand shah 
Designation  Research officer 
Affiliation  Regional research Institute of Unani Medicine ,Srinagar(CCRUM Ministry of AYUSH) 
Address  Regional Research Institute of Unani medicine Srinagar Naseem Bagh ,Habak Crossing

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006180746  
Fax    
Email  dr.arjumandshah111@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arjumand shah 
Designation  Research officer 
Affiliation  Regional research Institute of Unani Medicine ,Srinagar(CCRUM Ministry of AYUSH) 
Address  Regional Research Institute of Unani medicine Srinagar Naseem Bagh ,Habak Crossing

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006180746  
Fax    
Email  dr.arjumandshah111@gmail.com  
 
Source of Monetary or Material Support  
Central Council For Research in Unani Medicine New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine New Delhi 
Address  61-65 Institutional Area, Opp. D-Block, Janakpuri, New Delhi 110058 
Type of Sponsor  Research institution 
 
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 Arjumand Shah  Regional Research institute of Unani Medicine   OPD 103 Ground floor Regional Research Institute of Unani Medicine
Srinagar
JAMMU & KASHMIR 
7006180746

dr.arjumandshah111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RRIUM, Srinagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hijamah Bi Shart (Wet cupping)  It is a technique carried out by application of cup on the body surface for evacuation of the morbid materials, from the diseased part and to encourage the blood flow to the affected site.Wet cupping therapy should be given weekly for a period of 30 days in another group. 
Intervention  Hijamah Bila Shart (Massage cupping)  It is a technique carried out by application of cup after pouring medicated oil on the body surface then creating vacuum by special suction apparatus for the diversion of the morbid materials from the diseased part.Massage cupping therapy shall be given in one group on every alternate days for a period of 30 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Symptoms of
1)Pain neck radiating in arm
2)Paraesthesia
3)Radiological diagnosis of cervical spondylosis
 
 
ExclusionCriteria 
Details  1)Traumatic arthritis
2)Spinal cord disorders
3)Psycho somatic disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Neck Pain Disability Scale and VAS
2)Goniometer reading
3)Kellegran and Lawrence scale
4)MRI (If indicated)
5)Beck Depression Scale
6)Doppler (Previous H/O stroke or other carotid artery diseases)
 
30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1)Pain Intensity
2)Restricted Movements
3)Radiological Changes
4)Radiculopathy
5)Quality of life
6)Vascularity
 
30 Days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/05/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Osteoarthritis is a major health problem due to its prevalence, costs and levels of pain and disability. Risk factors include age, obesity, injury, genetic profiles and females being at more risk .But degenerative changes in cervical spine are higher in males .The unani scholars have mentioned the regimes for the treatment of these diseases .But the effect of these regimens need to be validated. Long term use of NSAIDs and muscle relaxants, the corner stone of OA is not recommended due to its side effects on kidney and liver .Other drugs used in allopathic medicine like Gabapentin cause mental depression , similarly long term use of drug Botulium toxin cause dysphasia, respiratory compromise and sometimes anaphylactic shock.Many studies have validated cupping in cervical spondolysis. Mechanism of action for this effect has been proposed however not much data is there to prove those actions. Also no study have been done to develop proper SOPs for frequency of massage and wet cupping . Hence present study is designed to compare the efficacy of wet cupping with massage cupping, to develop SOPS for frequency of both regimes and to study the sustainability of the efficacy of cupping.


 
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