Panchakarma procedures in the management of Lumber Spondylosis

Phase 2

Completed

• Conditions: Other spondylosis,

• Registration Number: CTRI/2020/03/024268
• Lead Sponsor: National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur

Brief Summary

This trial will be done to compare clinical efficacy of Baladiyapana Basti and Bala Taila Matra Basti in the management of Katigraha with special reference to Lumbar Spondylosis. This is an interventional, randomized,open clinical trial. The sample size is 60 with 2 groups, each group having a sample size of 30 patients. In group A Baladiyapana Basti will be administered in a dose of 600 ml every day through Rectal route as per the Standard Operating Procedure (SOP) of Nirhu Basti administration of the P.G. Department of the Panchakarma for a treatment period of 16 day. The time of administration will be early Noon (empty stomach) .In group B Bala Taila Matra Basti will be administered in a dose of 60 ml every day through Rectal route as per the Standard Operating Procedure (SOP) of Anuvasna Basti of the P.G. Department of the Panchakarma for a treatment period of 16 days. The time of administration will be Late Noon (immediately after meal ~ Aadhrapani ).The assessment of the clinical response in the total number of patients will be made on - Primary outcome – VAS (Visual Analogue Scale) and Oswestry disability index (ODI) scale and Secondary outcome – Physical component scores (PCS) of SF-36.Primary assessment of the patients will be done at baseline. Regular assessment will be done on every visit till completion of trial i.e. on 16th day. Patient will be further followed up on fifteenth day after the completion of the trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-04
• Last Update Posted: 2021-06-30
• Study Completion: 2021-08-06

Recruitment & Eligibility

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

Inclusion Criteria

• Patients suffering from classical signs and symptoms of Katigraha w.s.r to Lumbar spondylosis.
• Patients between 40 yrs to 60 yrs of age.
• Male or female Patient willing and able to participate in the study for 16 days and follow up period of 15 days.
• Patients able to provide informed consent.
• 5.Grade 2 and Grade 3 in X-ray findings through Lane Radiographic grading of lumbar disc degeneration on lateral views.

Exclusion Criteria

• 1.Patients suffering from any acute diseases, infectious diseases, metabolic diseases, chronic diseases (like rheumatoid Arthritis, DM, Gout, TB, SLE, Ankylosing spondylitis etc) and other disease that may interfere with the course of treatment.
• Patients suffering from Stenosis of spinal canal, Myelopathy (MRI optional), Lumbar carcinoma, spinal tumour or malignant tumours in any part of the body.
• All type of Lumbar surgery or implanted instrumentation or prosthesis.
• Patient having chronicity more than 5 yrs.
• Pregnant women and lactating women are excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The assessment of the clinical response by VAS (Visual Analogue Scale) and Oswestry disability index (ODI) scales	One Month

Secondary Outcome Measures

Name	Time	Method
The assessment of the clinical response by Physical component scores (PCS) of SF-36	One Month

Trial Locations

Locations (1)

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

National Institute of Ayurveda Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Sachin Sharma

Principal investigator

9805442774

sachinsharma1745@gmail.com