Clinical study on local application of oil on lower back and anal administration of drugs in the management of lower backache

Phase 2/3

Not yet recruiting

• Conditions: Lumbar spondylosis

• Registration Number: CTRI/2017/08/009504
• Lead Sponsor: National Institute of Ayurveda Jaipur

Brief Summary

This study is a open lebel parallel group trial comparing the efficacy of Matra basti(oily medicated enema) and Kati basti (local application and retention of oiil in lumbosacral region) with Sahachar taila in the management of Katigraha w.s.r. to Lumbar spondylosis.  In one group Matra basti in the dose of 75 ml per day for 16 days  will be given. In another group kati basti with Sahachar oil will be applied for 16 days. The trial will be conducted in National Institute of Ayurveda Jaipur India with primary outcome of improvement in modified oswestry low back pain disability index.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-12
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

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

Inclusion Criteria

• Patients fulfilling the diagnostic criteria[Walking disability(10m walking test),tenderness, with confirmative degenerative changes in X-rays of lumber spine AP & L view, fulfilling the Modified Oswestry low back pain disability index(MOLBPDI).].
• Patient without any anatomical deformity -patient willing to sign the consent for study participation.

Exclusion Criteria

Lumber carcinoma, Diabetes Mellitus, Chronic Renal Failure, Rheumatoid Arthritis, Gout, Systemic Lupus Erythematosus, Tuberculosis in bone, Ankylosing Spondylosis, pregnancy, lactation or any other systemic illnesses.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in MOLBPDI- Modified Oswestry low back pain disability index	30 days

Secondary Outcome Measures

Name	Time	Method
improvement in Visual analogue scale,improvement in 10 meter walking test and improvement in lane grading of lumbar disc degeneration scale for degenerative changes.	1 month

Trial Locations

Locations (1)

National Institute of Ayurveda Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Sarvesh Kumar Singh

Principal investigator

8739860237

sarveshksingh21@gmail.com