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.

An open labelled, randomized single centric comparative clinical Study to evaluate the efficacy of the Ayurvedic Kneesol oil to claim substantiation in osteoarthritis compared with Dr Ortho oil and Diclofenac gel (1% w/w) or Diclofenac spray (1mg).

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/052115

Enrollment

Registered

2023-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.History of less than 30 min of morning sickness. 2. Clinical signs and symptoms corresponding to hip and/or knee osteoarthritis for the previous three months. 3. Radiologically diagnosed osteoarthritis. 4. Subjects should have significant arthritic pain (Screening WOMAC score between 10-40 or Visual Analogue Scale score (VAS) between 4 to 9. 5. ESR 6. Willingness to sign the informed consent, follow the protocol and participate in clinical trial voluntarily.

Exclusion criteria

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. 5. Patients administering any herbal or topical herbal pain relief agents. 6. 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.

Design outcomes

Primary

Measure	Time frame
1. A decrease in WOMAC osteoarthritic index and 2. A decrease in the VAS scores. Timepoint: 12 weeks	—

Secondary

Measure	Time frame
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. Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactGagan Goswami

Pharexcel Consulting Private Limited

info@pharexcelconsulting.com9878551428

Outcome results