A prospective open labelled non Randomized phaseII clinical trial on VISHNUKIRANTI KUDINEER in the management of CEGANAVADHAM(CERVICAL SPONDYLOSIS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1.Reduction of the symptoms of painin 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 VISHNUKIRANTI KUDINEER in the management of CEGANAVADHAM(CERVICAL SPONDYLOSIS). The trial drug will be administered at the dose of 30-60 ml /twice a day (orally) 45 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary out come will be the evaluations of siddha diagnostic parameters, assessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) noticed and 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
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Neck pain radiating to upper limb with or without numbness, guiddiness and neck stiffness Restriction neck movememts Willing for doing laboratory investigation and xray imaging The neck diability index score should be equal or greater than 40%.
Exclusion Criteria
- •Age less than 20 greater than 60 Traumatic injury Systemic hyper tension Ischeamic heart diseases Chronic kidney disease Tuberculosis of spine Secondary maliganancy Chronic systemic illness Congenital spinal anomaly Pregnancy Lactating mother Extra cervical rib.
Outcomes
Primary Outcomes
1.Reduction of the symptoms of painin neck and upper limbs
Time Frame: 45 days
Improvement of the range of movements in the neck and upper limbs
Time Frame: 45 days
The outcome is aimed at reducing pain and increasing the range of movements
Time Frame: 45 days
Good improvement-score 10%/below10%
Time Frame: 45 days
Moderate improvement-score10-20%
Time Frame: 45 days
Mild improvement-score 20-30%
Time Frame: 45 days
No improvement-score 40%
Time Frame: 45 days
Secondary Outcomes
- To evaluate the physicochemocal, phytochemicals, biochemical analysis of clinical trial drug(To evaluate the safety profile for acute and subacute toxicity of the trial drug)