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Clinical Trials/CTRI/2023/05/052585
CTRI/2023/05/052585RecruitingPhase 2

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.

Central Council for Research in Unani Medicine New Delhi1 site in 1 country120 target enrollmentStarted: May 15, 2023Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
2)Goniometer reading

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Symptoms of 1)Pain neck radiating in arm 2)Paraesthesia 3)Radiological diagnosis of cervical spondylosis.

Exclusion Criteria

  • Traumatic arthritis 2)Spinal cord disorders 3)Psycho somatic disorders.

Outcomes

Primary Outcomes

2)Goniometer reading

Time Frame: 30 Days

6)Doppler (Previous H/O stroke or other carotid artery diseases)

Time Frame: 30 Days

1)Neck Pain Disability Scale and VAS

Time Frame: 30 Days

3)Kellegran and Lawrence scale

Time Frame: 30 Days

4)MRI (If indicated)

Time Frame: 30 Days

5)Beck Depression Scale

Time Frame: 30 Days

Secondary Outcomes

  • 1)Pain Intensity(2)Restricted Movements)

Investigators

Sponsor
Central Council for Research in Unani Medicine New Delhi
Sponsor Class
Research institution

Study Sites (1)

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