A Clinical trial on Sangan Ilai Kudineer in the management of Cegana Vatham (Cervical Spondylosis)

Phase 2

Not yet recruiting

• Conditions: Cervical disc disorder with radiculopathy,

• Registration Number: CTRI/2019/05/019003
• Lead Sponsor: Govt 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-14
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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 3.
• Diabetes Mellitus 4.
• Ischemic heart disease 5.
• chronic kidney disease 6.Tuberculosis in spine 7.Secondary malignancy 8.Chronic systemic illness 9.Congenital spinal anomalies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Improvement of the range of movements in the neck and upper limbs	45 days
1.Reduction of pain in neck and upper limbs	45 days

Secondary Outcome Measures

Name	Time	Method
1.Evaluation of pharmacological, biochemical and phytochemical analysis of trial drug	2. Determination of safety profile of trial drug

Trial Locations

Locations (1)

Govt Siddha Medical and College; 🇮🇳 Tirunelveli, TAMIL NADU, India

Govt Siddha Medical and College

🇮🇳Tirunelveli, TAMIL NADU, India

S DHIVYA

Principal investigator

8220066540

dhivyasundararajan1@gmail.com