CTRI/2022/11/047397招募中3 期
A double blind, randomized, three-arm, parallel group, multi-center, placebo-controlled trial toevaluate the safety and efficacy of Boswellin® Super in the management of Osteoarthritis of knee.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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 of either sex, 40 to 75 years of age.
- •2. Participants newly diagnosed with degenerative hypertrophy OA
- •(imaging diagnosis)
- •3. Participants whose knee KL (Kellgren-Lawrence) grade is I-II.
- •4. Participant with the pain perception ranging from 30 to 100 when
- •measuring VAS (Visual Analog Scale) of 0 â?? 100mm.
- •5. Willing to come for regular follow -up visits.
- •6. Able to give written informed consent and comply with the
- •requirements of the trial.
排除标准
- •1. Known history of hypersensitivity to herbal extracts or dietary
- •supplements.
- •2. Pregnant women, lactating women and women of childbearing
- •potential not following adequate contraceptive measure, women who
- •were found positive for urine pregnancy test.
- •3. Non degenerative joint diseases or other joint degenerative diseases
- •(musculoskeletal disorders) which will interfere with the evaluation of
- •OA (Rheumatoid arthritis, active gout, recent joint trauma (target joint),
- •or joint infection).
- •4. Participant with moderate or severe synovitis: KL (Kellgren-Lawrence)
- •grade III or higher.
- •5. Participants incapacitated or bound to wheelchair or bed and unable to
- •carry out self-care activities.
- •6. Participant with a history of knee or hip replacement surgery.
- •7. Treatment with intra-articular injection of corticosteroids into the knee
- •within 3 months preceding study.
- •8. Pre-existing or recent onset of demyelinating disorders.
- •9. Participants with a ruptured meniscus.
- •10. Evidence of several renal, hepatic, or hemopoietic diseases or severe
- •cardiac insufficiency as revealed by laboratory investigations.
- •11. Participant with chronic diseases of kidney, liver, or gastrointestinal
- •tract, cardiovascular, endocrine, or nervous system.
- •12. Participants with uncontrolled hypertension and uncontrolled diabetes.
- •13. Clinically significant untreated hyperlipidaemia in context of a
- •cardiovascular risk.
- •14. Medication:
- •ï?· Drug addiction
- •ï?· Participants who have used the following substance within 1
- •week prior to screening â?? glucosamine sulfate, chondroitin
- •sulfate, NSAID, glucocorticoids, or steroids.
- •ï?· Participant who has used hyaluronate within a month prior to
- •ï?· Participants who have used the below dietary supplement
- •within the past 30 day â?? Boswellia, Omega3, Collagen,
- •Curcumin etc.
- •15. History of having received any investigational drug or participated in
- •any other clinical trial which ended in preceding month or currently
- •16. Lifestyle:
- •ï?· Alcoholics (inability to control drinking due to both physical
- •and emotional dependence on alcohol characterized by
- •uncontrolled drinking and preoccupation with alcohol)
- •ï?· History of chronic smoking (more than 2 cigarettes a day)
- •17. Ayurvedic formulation or any form of CAM (Complimentary
- •Alternative Medicine) therapy in the preceding 2 months.
研究者
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