A clinical trial on Marutham Pattai Chooranam in the management of Thandaga Vatham(Lumbar spondylosis)

Phase 2

Not yet recruiting

• Conditions: Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,

• Registration Number: CTRI/2019/05/019064
• Lead Sponsor: Government Siddha Medical College and Hospital Palayamkottai

Brief Summary

This study is prospective,open labelled,non-randomized phae II clincal study to evaluate the therapeutic efficacy of MARUTHAM PATTAI CHOORANAM in the management of Thandaga vatham (Lumbar Spondylosis).The trial drug will be administered at the dose of 35mg/kg/BW/twice a day orally A/F along with hot water as adjuvant for 45 days in 60 patients(30 in OPD +30in IPD).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 the trial drug Marutham Pattai Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters assessment of safety profile of trial drug,  assessment of pharamcological  and biochemical parameters of the trial drug

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Last Update Posted: 2019-09-05

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Patients having clinical symtoms of lumbar spondylosis 2.
• Patients with low back pain with radiograph of lumbosacral spine showing a.loss of natural lumbar lordosis b.Reduction in disc space c.formation of osteophytes d.osteoporosis e.subluxation of vertebra 3.

Exclusion Criteria

1.pregnant women 2.TB of spine 3.Systemic Lupus Erythematosus 4.Congenital scoliosis,kyphosis 5.Patients in treatment for any other system of medicine for the same problem during clinical trials 6.Patients with lumbar spondylosis need in other emergency treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in clinical symptoms of Lumbar Spondylosis	45 days

Secondary Outcome Measures

Name	Time	Method
1.Determination of safety profile,Pharmacological and bio chemical parameters of trial drug	2.Evaluation of additional effects and siddha parameters changes in Thandaga Vatham

Trial Locations

Locations (1)

Government Siddha Medical College and Hospital Palayamkottai; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College and Hospital Palayamkottai

🇮🇳Tirunelveli, TAMIL NADU, India

D Nesanthine

Principal investigator

8489889079

devadasnisha5@gmail.com