A study to assess the efficacy and safety of Ayurvedic treatment Kneesol oil to compare with Dr Ortho oil and Diclofenac gel in Osteoarthritis patients.

Phase 4

Recruiting

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

• Registration Number: CTRI/2023/04/052115
• Lead Sponsor: Madhusudan Healthcare

Brief Summary

Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage that cushions the ends of the bones wears down over time. Although osteoarthritis can damage any joint, the disorder most commonly affects joints in your hands, knees, hips and spine.

Osteoarthritis symptoms can usually be managed, although the damage to joints can’t be reversed. Staying active, maintaining a healthy weight and receiving certain treatments might slow progression of the disease and help improve pain and joint function 1.

Kneesol Oil is an advanced proprietary Ayurvedic medicine indicated for effective management of Pain & inflammation of knee and joints associated with Osteoarthritis. The Oil is rational combination of clinically reported potent anti-inflammatory & analgesic herbs formulated in a fixed oil by following traditional Ayurvedic processing methods. The ingredients of kneesol oil are Zinziger officicnale, Allium sativa, Trachyspermum ammi and Trigonella foenum-graceum. The phytochemical constituents like flavonoids, phenols, thymol and the active substances like selenium, allicin and organosulfur are responsible for suppressing or inhibiting the inflammatory pathways and thus decreasing the oxidative stress, thereby modulating the pain and inflammation caused by the osteoarthritic.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-29
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 1.History of less than 30 min of morning sickness.
• Clinical signs and symptoms corresponding to hip and/or knee osteoarthritis for the previous three months.
• Radiologically diagnosed osteoarthritis.
• Subjects should have significant arthritic pain (Screening WOMAC score between 10-40 or Visual Analogue Scale score (VAS) between 4 to 9.
• ESR < 40 mm/hr.
• Willingness to sign the informed consent, follow the protocol and participate in clinical trial voluntarily.

Exclusion Criteria

• 1.Seriously overweight, defined as body mass index of >35 2.
• post-surgical pain patients 3.
• Alcohol or drug abuse during the last three years 4.
• Patients incapacitated or bound to wheel chair or bed and unable to carry out self-care activities.
• Patients administering any herbal or topical herbal pain relief agents.
• The patients with current or recent corticosteroid treatment; or ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicines or concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnotic, excessive alcohol, NSAIDs. 7.
• History of active peptic ulcer, severe renal, hepatic or hemopoietic disease or severe cardiac insufficiency or undergoing coronary artery bypass graft (CABG) surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. A decrease in the VAS scores.	12 weeks
1. A decrease in WOMAC osteoarthritic index and	12 weeks

Secondary Outcome Measures

Name	Time	Method
1. To assess the change in the biochemical parameters (CRP, CTX-1, ESR, LFT).	2. To assess the change in the digitalized X ray for the gap between femur and tibia to be measured at three points for cartilage damage and recovery.

Trial Locations

Locations (1)

Sapthagiri Institute of Medical Sciences & Research Centre (SIMSRC); 🇮🇳 Bangalore, KARNATAKA, India

Sapthagiri Institute of Medical Sciences & Research Centre (SIMSRC)

🇮🇳Bangalore, KARNATAKA, India

Dr Mahesh G

Principal investigator

9964428994

drmaheshg85@gmail.com