| 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
|
|
|
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
|
|
|
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. |