A prospective open labelled, single arm, non-randomized, single centric, phase II clinic trail to determine the effectiveness of kanduparangi chooranam in the management of ceganavatham (cervical spondylosis)
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Government Siddha Medical College and Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. The outcome is aimed at reducing pain and increasing range of movement.
Overview
Brief Summary
The study is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRAIL TO DETERMINE THE EFFECTIVENESS OF KANDUPARANGI CHOORANAM IN THE MANAGEMENT OF CEGANAVATHAM (CERVICAL SPONDYLOSIS). The trial drug will be administered at the dose of 3gms twice a day orally with hot water for 45 days on 40 (20 OP + 20 IP) patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli,Tamilnadu. The primary outcome will be determining the clinical effectiveness of KANDUPARANGI CHOORANAM on CEGANAVATHAM (CERVICAL SPONDYLOSIS). The secondary outcome will be evaluating the siddha diagnostic parameters, assessment of pharmacological and biochemical parameters of trial drug. Incase of any Adverse Events (AE) noticed, it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Neck pain radiating ro upper limb without numbness, giddiness and neck stiffness
- •Restricted neck movements
- •Willing for doing laboratory investigations and X-Ray imaging
- •The neck disability index score should be equal or greater than 40%.
Exclusion Criteria
- •Age: Below 20 years and above 60 years
- •Traumatic injury
- •Systemic hypertension
- •Ischemic heart diseases
- •Chronic kidney disease
- •Tuberculosis in spine
- •Secondary malignancy
- •Chronic systemic illness
- •Congenital spinal anomalies.
Outcomes
Primary Outcomes
1. The outcome is aimed at reducing pain and increasing range of movement.
Time Frame: 45 days
2. Reduction of OSWESTRY DISABILITY INDEX score to 10 points on comparison with OSWESTRY DISABILITY INDEX score prior to the treatment.
Time Frame: 45 days
Secondary Outcomes
- To evaluate physicochemical, phytochemicals, biochemical analysis of clinical trial drug(To evaluate the safety profile for acute and subacute toxicity of the trial drug)
Investigators
Dr K ROHINI
Government siddha medical College, Palayamkottai.