A clinica trial on VISHNUKIRANTI KUDINEER in the management of CEGANAVADHAM (CERVICAL SPONDYLOSIS)

Phase 2

Not yet recruiting

• Conditions: Other spondylosis, (2) ICD-10 Condition: M478||Other spondylosis,

• Registration Number: CTRI/2022/02/040374
• Lead Sponsor: Government Siddha Medical College and Hospital

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-16
• Study Start: 2022-02-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction of the symptoms of painin neck and upper limbs	45 days
Improvement of the range of movements in the neck and upper limbs	45 days
The outcome is aimed at reducing pain and increasing the range of movements	45 days
Good improvement-score 10%/below10%	45 days
Moderate improvement-score10-20%	45 days
Mild improvement-score 20-30%	45 days
No improvement-score 40%	45 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Govt siddha medical college and hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Govt siddha medical college and hospital

🇮🇳Tirunelveli, TAMIL NADU, India

Sarumathi S

Principal investigator

7639531129

mugamathi53@gmail.com