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临床试验/CTRI/2023/05/052962
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

发起方
Star Hi Herbs PvtLtd

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