CTRI/2020/07/026603暂停不适用
A prospective, interventional, randomized, double-blind, multiple dose, parallel, placebocontrolledstudy to assess the efficacy of dietary supplement capsules of OmniActive HealthTechnologies, India, on joint health and muscle strength of subjects.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- WOMAC Index
研究概览
简要总结
To assess the effect of dietary supplement capsules compared to
Placebo capsules on joint health
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
- 35.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and/or female subjects aged between 35 and 75 years (both limits inclusive).
- •Clinical diagnosis of unilateral or bilateral knee osteoarthritis for at least greater than 3 months, as presented by pain in the knee at least for last 3 months.
- •Subject with index knee joint pain rated ≥ 60 on a 100-point Pain-VAS scale.
- •Subjects willing to be involved in regular physical activity such as walking, climbing stairs, recording forms, eating, exercise behaviors, etc.
- •Subjects who are able to walk for at least 6 minutes at a moderate-to-brisk pace on treadmill.
- •Subjects willing to avoid NSAIDs and other antiinflammatory medications during the study period.
- •Subjects who agree to stay weight stable during the study period.
- •Subject able to follow the instruction for Investigational product administration and is 100% compliant with Investigational product during placebo run-in period.
- •Female subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence: Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
- •OR Postmenopausal for at least 1 year.
- •OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the subject).
- •Subjects willing to provide written consent.
- •Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •Subjects with positive Urine Pregnancy Test at Screening /Randomization Visit.
- •Subjects with previous history of knee osteoarthritis for more than 3 years.
- •Subjects with previous history of any knee joint replacement surgery.
- •Subjects with severe knee osteoarthritis in Grade 4 as per Kellgren and Lawrence Scale.
- •Subjects unwilling to refrain from the use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health or local analgesics during the study duration.
- •Subjects with history hypothyroidism and have the thyroid deficiency except euthyroid.
- •History of allergy or sensitivity to Curcumin, Boswellia and Ashwagandha, related compounds or any component of the formulation.
- •Subjects with use of any immunosuppressive drugs in the last 12 months (including steroids).
- •Subjects with poorly controlled hypertension.
- •(Systolic Blood Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm Hg).
- •Subjects with history of uncontrolled diabetes.
- •Subjects with evidence of malignancy.
- •Use of Glucocorticoid injection or hyaluronic acid injection in the affected joint within 3 months prior to enrolment.
- •Subjects with a chronic pain syndrome and in the judgment of the Investigator is unlikely to respond to any therapy.
- •Subjects with history of significant trauma or surgery in the lower limb.
- •History or presence of active rheumatic disease that may be responsible for secondary knee osteoarthritis.
- •Subjects with history of deep vein thrombosis.
- •Subjects with history of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
- •Subjects with history of bilateral hip joint replacements.
- •Subjects with current use of the following medications: monoamine oxidase inhibitors, prescription or herbal weight loss medications/dietary supplement.
- •Any condition that, in the opinion of the investigator, renders the subject unable to participate in the study.
- •Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
- •Subjects who are taking calcium and vitamin D beyond RDA levels.
结局指标
主要结局
WOMAC Index
时间窗: Day 84 (week 12)
次要结局
- joint pain - VAS(Day 84 (week 12))
- WOMAC Index(Day 5)
- joint pain(Day 5)
- joint health-Lequesne Index(Day 5)
- endurance(Day 84 (week 12))
- muscle strength(Day 84 (week 12))
- joint health by Lequesne Index(Day 84 (week 12))
- inflammation(Day 84 (week 12))
- serum(COMP, Serum CTX-II and serum MMP-3)
- Quality of Life (QoL)(Day 84 (week 12))
- rescue medication(Day 84 (week 12))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Polyherbal Capsule Formulation for Joint HealthKnee DiscomfortPain Physical ActivityNCT02157701NewChapter, Inc.108
招募中
不适用
Joint Health StudyEffect of DrugNCT05438979Auburn University300
尚未招募
不适用
Efficacy and safety study of dietary supplements in chronic smokers individuals having mild to moderate hyperlipidemiachronic smokers mild to moderate hyperlipidemiaCTRI/2014/08/004838Olive Lifesciences Pvt Ltd60
已完成
2 期
Study of Jitongning Tablet to Treat SpondyloarthritisSpondyloarthritisNCT03932019Tasly Pharmaceutical Group Co., Ltd238
已完成
不适用
Verification of the improvement effect of simultaneous intake of proteoglycan derived from the salmon bone cartilage, non-denatured type II collagen derived from the salmon nasal cartilage, and olive-leaf extract on the knee joint and skin qualityHealthy volunteersJPRN-UMIN000039824oevir Co., Ltd.27