Effectiveness of varmam, aanai thipili dhravagam (internal) and kayathirumeni ennai (external) for Thandagavadham (lumbar spondylosis)

Phase 2

Not yet recruiting

• Conditions: Other spondylosis with radiculopathy,

• Registration Number: CTRI/2020/03/024166
• Lead Sponsor: Government siddha medical college chennai

Brief Summary

This is a phase II, non-randomized, comparative an open clinical evaluation of Varmam and Siddha trial drugs "Aanai thipili dhravagam" (internal) and "Kayathirumeni ennai" (external) for Thandagavadham (lumbarspondylosis). The

dosage of internal medication Aanai thipili dhravagam is 2 ml along with 30ml of water and will be administered twice a day after a meal. The time period of medication will be around 21 days and a sufficient amount of Kayathirumeni ennai will be given for 21days . The sample size for this study is 90 which will be categorized into 3 groups.  The first group will be given Varmam therapy, the second group will be given both internal and external medication and the final group will be given internal, external and varmam therapy. The trial drug Aanai thipili dhravagam contains some active herbs that possess anti-inflammatory, analgesic which will be helpful to reduce the symptoms of Lumbar spondylosis.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-03-14
• Study Start: 2020-03-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients having any one of the symptoms of lower back pain radiating to the lower extremities anteriorly, tenderness, numbness.
• Limitation of lower back movements.
• Patients who is willing to undergo necessary investigations.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of pain is assessed by Visual Analogue Scale,Improvement in range of movements, stiffness is assessed by using Oswestry Disability Index. Comparing the clinical symptoms and physical examinations before and after treatment.	21 days

Secondary Outcome Measures

Name	Time	Method
Assessed by comparing safety profile before and after treatment.	21 days

Trial Locations

Locations (1)

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

Government Siddha Medical College

🇮🇳Chennai, TAMIL NADU, India

Parameswari

Principal investigator

7358456402

paramesanjali26@gmail.com