Evaluation of herbal regimens in adults with acute/chronic pain and inflammation

Phase 2/3

Completed

• Conditions: Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,

• Registration Number: CTRI/2023/07/055431
• Lead Sponsor: BVG life Sciences Limited

Brief Summary

The present work is undertaken to assess the efficacy of herbal formulations in patients suffering from OA of the knee joint for 28 days maximum. The study population was 90 patients randomly divided into three equal groups of 30 individuals.

1. comparator arm – til oil and til oil-based cream (topical application)

2. Interventional arm 1- Pain oil -1 and Pain cream-1

3.-Interventional arm-2 Pain oil -2 and Pain cream-2

The oil formulations were tropically administered 1-2ml with 1-2g of cream  (as per the surface area on painful Knee joint) twice a day.

The primary outcome of the study was to analyze changes in VAS (Visual Analogue Scale) and the secondary outcome WOMAC Score was analyzed from Baseline to Week 4.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-30
• Study Completion: 2024-08-05
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 1.Patients between 40 and 70 years of age.
• 2.Patients with the clinical features of OA of Knee joint.
• 3.Patients fit for Snehanaand Swedana.
• 4.Patients with radiological findings of Osteoarthritis based on grade 0 to 4 on Kellgren and Lawrence system of classification of Knee OA along with clinical features.
• 5.Chronicity less than 3 years.

Exclusion Criteria

• 1)Patient, suffering from any chronic debilitating disease like T.B., D.M., Gout, Varicose veins, Asthma & other chronic problems etc.
• and having other serious pathology 2)Pregnant women and lactating mother 3)Associated with simple or compound fractures 4)Patients who have developed joint deformity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS (Visual Analogue Scale) for Pain	baseline to 28 days

Secondary Outcome Measures

Name	Time	Method
The Western Ontario & McMaster Universities Arthritis Index(WOMAC) score	baseline to 28 days

Trial Locations

Locations (1)

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

National Institute of Ayurveda hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Sarvesh Kumar Singh

Principal investigator

8739860237

sarveshksingh21@gmail.com