CTRI/2024/02/062580招募中3 期
A randomized double-blind placebo controlled clinical study for the comparative evaluation of efficacy and tolerability of proteoglycan in improving knee joint health in adult subjects with mild osteoarthritis - NI
Daehan Chemtech Co Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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.Ambulatory, male and female subjects 40-75 years of age.
- •2.KL (Kellgren-Lawrence) grade of 1 to 2.
- •3.At least 30 on 100 mm visual analogue scale.
- •4.Subjects having mild-to-moderate pain in knee joint upon completion of 30-second Chair Stand Test or 80-meter Fast-Paced Walk Test, and otherwise no knee pain at rest.
- •5.Subjects willing to refrain from taking ibuprofen, aspirin or other NSAIDs or any other pain reliever (OTC or prescription) during the entire trial.
- •6.Subjects willing to sign the informed consent and comply with study procedure.
- •7.Subjects able to complete 20-meter walk test.
排除标准
- •1. Subjects with any possible signs / indication / history of arthritis,
- •joint disorders including dislocations and quadriceps tendons tear.
- •2. Subjects with history of underlying inflammatory arthropathy or
- •severe RA or OA.
- •3.Subjects having used any immunosuppressive drugs in the last 6
- •months (including steroids or biologics) and those with history of
- •immune system and autoimmune disorders.
- •4.Subjects with a history of knee or hip joint replacement surgery, or
- •any hip or back pain which interferes with ambulation.
- •5.Subjects with BMI less than 18.5 or more than 30.
- •6.Subjects who consumed the medicines or supplements related
- •with joint health within 30 days before screening visit.
- •7.Subjects who are not acceptable for the test by the judgment of PI.
- •8.Subjects with the history of tobacco smoking.
- •9.Subjects expecting the surgery during the study duration period.
- •10.Female subjects, who are pregnant, breast feeding or planning to
- •become pregnant.
- •11.Subjects having known allergy to non-steroidal anti-inflammatory
- •drugs (NSAIDs) (including aspirin) or has a suspected
- •hypersensitivity, allergy or sensitivity to herbal products.
- •12.Subjects who have any physical disability which could interfere
- •with their ability to perform the functional performance measures
- •included in this protocol.
- •13.Subjects with history of gout.
- •14.Subjects who have received any corticosteroids, NSAIDs,
- •glucosamine, and or chondroitin, within the past 90 days prior to the
- •screening visit or any form of intra-articular treatment / injections with
- •corticosteroids or hyaluronic acid within 90 days preceding the
- •screening visit.
- •15.Subjects with the history of congestive heart failure or any
- •vascular conditions.
- •16.Subjects with the evidence or history of clinically significant (in the
- •judgment of the Investigator) hematological, renal, endocrine,
- •pulmonary, gastrointestinal, cardiovascular, hepatic or neurologic
- •diseases, or malignancies, hypothyroidism.
- •17.Subjects with history of systemic lupus erythematous (SLE).
- •18.Subjects with history of high alcohol intake (greeter than 2
- •standard drinks per day).
- •19.Subjects with history of any psychiatric disorders that may impair
- •the ability of subjects to provide written informed consent.
- •20.Subjects who have participated in any other trials involving
- •investigational or marketed products within 90 days prior to the
- •screening visit.
- •21.Subjects who are currently or within 30 days prior to the screening visit on prescription or OTC medications / pain relievers
- •such as acetaminophen / paracetamol, ibuprofen, aspirin or other
- •NSAIDs or any natural health product, (excluding vitamins).
研究者
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