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