A Randomized, Open label, Clinical study to evaluate the efficacy and safety of Amrutanjan Advanced Ortho Pain Relief + Oil in osteoarthritis and Rheumatoid arthritis patients - NI

Amrutanjan Health Care Limited, Tamil Nadu, India0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology
•(ACR) criteria and confirmed with X-rays and with grade I and II as per Kellgren and
•Lawrence classification system and patients previously diagnosed with Rheumatoid
•arthritis (grade I and II) as per the American Rheumatism Association.
•2. Have been on stable dose of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS) and
•other treatments for a minimum period of 3 months in the past.
•3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue
•Scale (VAS)
•4. Patient should have not participated in any other clinical trial during the past 3 months.
•5. Participants, who are willing to give written, signed and dated informed consent to
•participate in the study.

•1. Recent history of trauma to the knee joint.
•2. Having severe pain and inflammation, which is not getting controlled on NSAIDs
•3. Uncontrolled diabetic patients with Hba1C greater than 10.
•4. Pregnant or lactating
•5. Received any other investigational medicine within 7 days prior to screening which
•can interfere with investigational product activity
•6. Suffering from any illness which will interfere with present study as decided by
•clinical investigator
•7. History of hypersensitivity to any of the test products.
•8. Any condition (like instability of knee joint, ligament tear or loose bodies in knee
•joint) decided as unfit for study by Clinical investigator

发起方

Amrutanjan Health Care Limited, Tamil Nadu, India