An Open label, Phase II, Clinical Study to evaluate the efficacy and safety of polyherbal formulation DPOR/JR2007 in patients with osteoarthritis of the knee.

Deltas Pharma0 个研究点目标入组 45 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Patient between >= 40-75 years of age, (inclusive of both), previously diagnosed (3 months prior to screening) with osteoarthritis of knee (as per ACR criteria for osteoarthritis of knee) based on clinical findings.
•2.Primary knee OA according to ACR criteria - patients having knee pain and any 3 of the following determined by physical examination: less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, and no palpable warmth of synovium.
•3.Patient with moderate-severe pain (Score 1.5 - 2.5 on Likert scale of 5 in pain sub-score question 1 of WOMAC INDEX (Modified CRD version)
•4.Patient able to understand and follow study procedures, also willingness to adhere to treatment.
•5.Patient who agrees to participate in the study by giving his/her written informed consent.

•1.Patient having Body Mass index >=32.
•2.Patient suffering with psoriatic arthritis or having history of any other autoimmune diseases.
•3.Patient with clinically significant trauma or surgery in the target knee.
•4.Administration of NSAIDs within the 7 days prior to the inclusion in the study.
•5.Administration of any intra-articular treatment, glucosamine sulphate, chondroitin sulphate within the 3 months prior to their inclusion in the study.
•6.Patients suffering from severe systemic disease.
•7.History of hypersensitivity to any ingredient of the Investigational product.
•8.Subject received long term systemic Ayurvedic, Homeopathic or Herbal drug, three months prior to screening visit.
•9.Pregnant or lactating women. Women of child-bearing age not using effective contraception.

发起方

Deltas Pharma