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Clinical Trials/CTRI/2019/05/019003
CTRI/2019/05/019003Not yet recruitingPhase 2

A Prospective Open labelled, Non-randomized Phase II clinical trial of SANGAN ILAI KUDINEER in the management of CEGANA VATHAM (CERVICAL SPONDYLOSIS)

Govt Siddha Medical College and Hospital1 site in 1 country60 target enrollmentStarted: May 14, 2019Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
2.Improvement of the range of movements in the neck and upper limbs

Study Overview

Brief Summary

The study is a prospective open labelled phase II non- randomized clinical study to evaluate the therapeutic efficacy of SANGAN ILAI KUDINEER in the management if Cegana vatham( Cervical spondylosis). The trial drug will be administered at the dose of 100 ml BD A/F for 45 days in 60 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu . The Primary outcome will be the evaluation of therapeutic efficacy of trial drug SANGAN ILAI KUDINEER. The secondary outcome will be the evaluation of Siddha diagnostic parameters, assessment of safety profile of trial drug,assessment of pharamocological and biochemical parameters of trail drug.

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

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

Inclusion Criteria

  • 1.Neck pain radiating to upper limb with or without numbness, giddiness and neck stiffness.
  • 2.Restriction of neck movements.
  • 3.Willing for doing X-ray imaging.
  • 4.Neck disability index score should be equal or greater than 40%.

Exclusion Criteria

  • 1.Traumatic injury 2.systemic hypertension
  • Diabetes Mellitus
  • Ischemic heart disease
  • chronic kidney disease 6.Tuberculosis in spine 7.Secondary malignancy 8.Chronic systemic illness 9.Congenital spinal anomalies.

Outcomes

Primary Outcomes

2.Improvement of the range of movements in the neck and upper limbs

Time Frame: 45 days

1.Reduction of pain in neck and upper limbs

Time Frame: 45 days

Secondary Outcomes

  • 1.Evaluation of pharmacological, biochemical and phytochemical analysis of trial drug(2. Determination of safety profile of trial drug)

Investigators

Sponsor
Govt Siddha Medical College and Hospital
Sponsor Class
Government medical college

Study Sites (1)

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