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

Phase 4

Recruiting

• Conditions: Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH,

• Registration Number: CTRI/2023/04/052114
• Lead Sponsor: Madhusudan Healthcare

Brief Summary

*Rheumatoid arthritis* is an autoimmune disease. A chronic inflammatory disorder affecting many joints in which the body’s immune system attacks its own tissue, including those in the hands and feet. In severe cases, it attacks internal organs.

Rheumatoid arthritis affects joint linings, causing painful swelling. Over long periods of time, the inflammation associated with rheumatoid arthritis can cause bone erosion and joint deformity.

While there’s no cure for rheumatoid arthritis, physiotherapy and medication can help slow the disease’s progression. Most cases can be managed with a class of medications called anti-rheumatic drugs (DMARDS).

An advanced proprietary Ayurvedic medicine, Kneesol oil was indicated for effective management of pain and inflammation in knee and joints associated with rheumatoid arthritis. Clinically reported potent anti-inflammatory & analgesic herbs were rationally combined and formulated to a fixed oil by following traditional Ayurvedic processing methods. The key ingredients *Zinziger officicnale, Allium sativa, Trachyspermum ammi* and *Trigonella foenum-graceum* were used in the preparation of kneesol oil. The active phytochemical constituents like flavonoids, phenols, thymol and the dynamic materials like selenium, allicin and organosulfur are responsible for either suppressing or inhibiting the inflammatory pathways and thus diminishing the oxidative stress, thereby restraining the pain and inflammation caused by the rheumatoid arthritis

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: 36

Inclusion Criteria

• Aged between 18 and 75 years old of either sex.
• If rheumatoid arthritis is moderately or severely active, the disease activity during the screening period and the baseline period must meet the following criteria: Swollen joints count (SJC) ≥ 6 (based on 66 joint count) and tender joints count (Tender joints count: TJC) ≥ 6 (based on 68 joint count) (if the same joint has both swelling and Tenderness, this joint is included in the counts of swollen joints and tender joints).
• Morning stiffness in and around the joints for at least 6 weeks which is lasting at least 1 hr before the maximal improvement.
• Take medically approved non-drug contraceptive measures (such as drug-free intrauterine devices, condoms, female sterilization, and male sterilization) during the entire trial period and at least 3 months after the end of the medication, and no Pregnancy planner.
• Those who understand, voluntarily sign the informed consent form, and comply with the requirements of the research plan.

Exclusion Criteria

• Those who have received any medical supportive treatments (such as whitening drugs, drugs for anaemia (except folic acid), liver-protecting and enzyme-lowering drugs, blood transfusions, etc.) within 2 weeks before screening.
• Patients with acute myocardial infarction, unstable angina pectoris, stroke, and cardiac insufficiency within 6 months before screening.
• The kidney, lung, digestive tract, nervous system and other serious diseased individuals (such as: poorly controlled severe diabetes, hypertension, interstitial pneumonia, obstructive Lung disease, bronchospasm, etc.), the investigator judged that it is not suitable to join the research.
• Those who have a history of smoking, alcoholism, or drug abuse within 12 months before screening.
• People with other primary or secondary immunodeficiencies in the past or at the time of screening, including patients with a history of HIV infection and positive HIV test results.
• Patients administering any herbal or topical herbal pain relief agents.
• 7.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. 8.
• Those who have participated in other clinical studies within 3 months before screening.
• Women who are preparing for pregnancy, pregnancy, lactation, or who become pregnant during the planned trial period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the percentage of patients achieving a 20% of ACR response rate	12 weeks
SECONDARY OUTCOME	12 weeks

Secondary Outcome Measures

Name	Time	Method
. To estimate the change in DAS 28 score, VAS scoresand HAQ disability index (HAQDI) from baseline.	2. Change in the acute phase reactants ESR (mm/hr) and CRP (mg/L) which are unspecific and sensitive markers of the inflammatory process.

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