A clinical study on Pavattai ilai kudineer in the management of Thandaga Vatham (Lumbar Spondylosis)

Phase 2

Completed

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

• Registration Number: CTRI/2020/07/026372
• Lead Sponsor: Government siddha medical college and hospital

Brief Summary

A study is a prospective open labelled phase II non randomized clinical study to evaluvate the therapeutic efficacy of pavattai ilai kudineer in the management of Thandaga Vatham ( Lumbar Spondylosis). The trial drug will be administered at the dose of 30 to 50 ml/Twice a day B/F 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 their evaluation of therapeutic efficacy of trial drug pavattai ilai kudineer.  The Secondary outcome will be they evoluation 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 event (AE) is notice and it will be referred to pharmacovigilance department of SCRI.  Further management of patient will be given in OPD facility.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-16
• Study Completion: 2021-04-17
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1)Patient presenting with pain and stiffness in the Lumbar region,radiating pain to buttocks and lower limbs, pain aggravating on forward and backward bending.
• 2)Schoper,SLR test positive in Thandaga Vatham.
• 3)Patient complaining of back pain functional scale score should be range from below 30.
• 4)Patient willing to participate the clinical trial.
• 5)Confirmed Radiological diagnosis in Lumbar Spondylosis.

Exclusion Criteria

1)Tuberculosis of spine 2)SLE 3)Chronic kidney disease 4)Fracture of spine 5)Congenital Spino Vertebral Deformities 6)Mixed connective disease 7)Pregnency 8)Lactating mother 9)Chronic liver disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
If during treatment or after treatment reduction of the following symptoms	6 weeks
Pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggravating on forward and backward beding.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Documentation of analgesic activity through SCALE SCORE.	45 days

Trial Locations

Locations (1)

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

Government Siddha Medical College

🇮🇳Tirunelveli, TAMIL NADU, India

G pazhanimurugan

Principal investigator

7502511132

drpalanichinna001@gmail.com