CTRI/2016/07/007123已完成不适用
A Randomized Double-Blind Placebo Controlled Clinical Study for Comparative Evaluation of Efficacy and Tolerability of a Novel Composition and a Commercial Extract of Boswellia serrata in Improving Knee Joint Health of Non-Osteoarthritic Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement in 80 meter Fast-Paced walk test
研究概览
简要总结
Eligiblehealthy subjects in the age group of 30-65 years of both genders will berandomized into 1:1:1 and will be assigned to either study medication orplacebo or comparator. The study medication is a novel herbal formulation withknown health benefits and has been used as the Ayurvedic and Herbal remedies inIndia since long time. The comparator product is a commercial extract of*Boswellia serrata.*Subjectshaving mild-to-moderate pain in knee joint will be enrolled into this studyafter assessing inclusion-exclusion criteria mentioned in the approved studyprotocol. The purpose of this study is to assess the clinical effectiveness andsafety of the novel herbal formulation vs. Placebo vs. comparator in reducingknee joint pain and other associated symptoms in healthy individuals. The totalstudy duration is 60 days comprising five clinical visits including threetimes blood testing at different intervals. Physical examination and adverseevent information will be assessed at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Ambulatory, male and female subjects 30 – 65 years of age with a Body Mass Index (BMI) of approximately 18 to 29.9 kg/m
- •â€¢Only non–osteoarthritic subjects with radio graphic evidence by Kellgren.
- •Lawrence grade
- •â€¢Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. •Results of screening should be within normal range or considered not clinically significant by the Principal Investigator. •Subjects having mild-to-moderate pain in knee joint upon completion of 30 sec Chair Stand Test or 80 meter Fast-Paced Walk Test, and otherwise no knee pain at rest. •Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial. •Willing to sign the informed consent and comply with study procedure.
排除标准
- •â€¢Subjects with any possible signs/ indications/ history of arthritis, joint disorders including dislocations and quadriceps tendons tear.
- •â€¢History of underlying inflammatory arthropathy or severe RA or OA.
- •â€¢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.
- •â€¢Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation.
- •â€¢Expectation of surgery during the study duration period.
- •â€¢Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •â€¢Subject having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
- •â€¢Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
- •â€¢History of Gout.
- •â€¢Have taken any corticosteroid, indomethacin, glucosamine+ chondroitin, within 3 months prior to the Treatment Period, Visit 1 or intra-articular treatment / injections with corticosteroid or hyaluronic acid within 6 months preceding the treatment period.
- •â€¢History of congestive heart failure or any vascular conditions.
- •â€¢Subjects with HIV Positive status.
- •â€¢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.
- •â€¢History of Systemic Lupus Erythematous (SLE).
- •â€¢High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
- •â€¢History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •â€¢Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit.
- •â€¢Have taken acetaminophen / paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the Screening Visit.
结局指标
主要结局
Improvement in 80 meter Fast-Paced walk test
时间窗: Day 1, Day 7, Day 30, Day 60
次要结局
- Improvement from baseline to end of the trial period in :(•30 sec Chair Stand Test)
研究者
研究点 (1)
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