CTRI/2023/05/052962已完成2 期
To assess the efficacy and evaluate the anti-inflammatory effects of Boswellia serrata extract in Osteoarthritis
Star Hi Herbs PvtLtd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Participants between 40 to 75 years
- •2.Suffering from unilateral or bilateral OA of the knee within grade-2 according to the Kellgren-Lawrence Classification of Osteoarthritis
- •3.Patients with a minimum pain visual analogue scale (VAS) score 3.5 to 7.4
- •4.Lequesnes functional index between 5-7 points
- •5.The Western Ontario McMaster Index (WOMAC) score should be less than or equal to 48
- •6.Participants have to be able to walk and give both verbal and written information regarding the study
- •7.Subjects willing to comply with the prescribed treatment regime for the duration of study participation.
排除标准
- •1.Expectations for surgery in the near future
- •2.Patients who are on medication for OA.
- •3.Known hypersensitivity to herbal extracts or dietary supplements
- •4.Pregnant or lactating women and women of child bearing potential not following adequate contraceptive measure or women who were found positive for urine pregnancy test
- •5.Non degenerative joint diseases or other joint degenerative diseases
- •6.Incapacitated or bound to a wheelchair or bed and unable to carry out self ?care activities
- •7.Current or recent (in the last 3 months) oral or intra ?articular corticosteroid therapy
- •8.Pre-existing or recent onset of demyelinating disorders or type I diabetes
- •9.Ongoing with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine
- •10.Renal, hepatic, hematopoietic disease, hypertension, severe cardiac insufficiency, congestive heart failure and untreated hyperlipidemia (cardiovascular risk)
- •11.Ayurvedic formulation or any form of complementary alternative medicine therapy in the preceding 2 months
- •12.Receiving any investigational drug or participating in any other clinical trial that ended in preceding month or currently ongoing
- •13.Patients who needed high dose of NSAIDs or analgesics; and
- •14.Inability to comply with study procedures.
研究者
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