A clinical study of Mavilingapattai Kudineer in the management of Thandagavatham (Lumbar Spondylosis)

Phase 2

Not yet recruiting

• Conditions: Other spondylosis,

• Registration Number: CTRI/2021/02/031215
• 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 Mavilingapattai Kudineer in the management of Thandagavatham (Lumbar Spondylosis). The trial drug will be administered orally at the dose of 30 ml after the food, twice a day for a period of 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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-01-28
• Study Start: 2021-02-27

Recruitment & Eligibility

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

Inclusion Criteria

• Patient presenting with pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggravating on forward and backward bending.
• Patient with positive Schober and Straight Leg Raising test.
• Patient complaining of back pain functional scale score should be range from below 30.

Exclusion Criteria

• Age below 30 and above 60 years.
• Tuberculosis of spine.
• Systemic Lupus Erythematosus Chronic Kidney Disease Fracture of spine Congenital Spino vertebral deformities Mixed connective disease Pregnancy Lactating mother Chronic Liver Disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the symptoms of the pain in lumbar and lower limbs.	45 days
Improvement of the range of movements in the Lumbar and lower limbs.	45 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of additional effects and siddha	parameters changes in Thandagavatham

Trial Locations

Locations (1)

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

Government siddha medical college and hospital

🇮🇳Tirunelveli, TAMIL NADU, India

Dr P Mullaikodi

Principal investigator

9080394757

drmullaikodiparamasivam@gmail.com