A Randomized, Double-Blind, Placebo-controlled, Parallel Design Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy Subjects

Vedic Lifesciences Pvt. Ltd.10 个研究点分布在 1 个国家目标入组 375 人开始时间: 2022年10月10日最近更新: 2022年11月30日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Vedic Lifesciences Pvt. Ltd.
入组人数: 375
试验地点: 10
主要终点: range of motion (active flexion and extension)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Randomized, Double-Blind, Placebo-controlled, Parallel Design Clinical Study to Evaluate the Effect of Different Doses of UC-II® Supplementation on the Range of Motion & Joint Discomfort in Healthy Subjects

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Triple (Participant, Care Provider, Investigator)

盲法说明

Envelope blinding chits

入排标准

年龄范围: 20 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Physically active male and female both, aged ≥ 20 to ≤ 65 years with the daily routine of physical exercise (exercise such as walking, jogging, running, cycling, climbing stairs, squatting or any other exercise on investigator's discretion that involves knee joint movement) for at least 3 days a week.
•Subject with a history of 4-9 months related to knee joint pain aggravation on physical stress.
•Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m
•Fasting blood glucose (FBG) ≤ 125 mg/ dl.
•Subject with self-reported joint pain of ≥ 70 mm on a 100-point VAS scale after 10±2 minutes of walking on a treadmill using modified Naughton protocol.
•Subject with pain ≤30 mm at rest on Pain VAS
•Subject not diagnosed as a case of OA / RA confirmed by the American college of rheumatology (ACR) criteria.
•The subject is willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements.
•The subject is willing to abstain from the restricted supplements and medications prior to inclusion and throughout the study period.
•Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.

排除标准

•Obese Subject with BMI > 29.9 kg/m
•Subject's inability to complete the exercise protocol of 10±2 minutes at screening.
•Subject with the clinical diagnosis of any form of joint disease such as Osteoarthritis (OA).
•Subject with the clinical diagnosis of any form of autoimmune disorder related to the joint such as Rheumatoid arthritis (RA).
•A subject suffering from Insomnia and restless leg syndrome.
•Uncontrolled hypertensive defined as subject currently on an anti-hypertensive drug with systolic Blood Pressure ≥ 140 mm Hg and/ or & diastolic blood pressure ≥ 90 mm Hg
•Uncontrolled diabetics currently on anti-diabetic medication with Fasting blood glucose (FBG) ≥ 126 mg/ dl.
•Systolic Blood Pressure ≥ 140 mm Hg and/ or & diastolic blood pressure ≥ 90 mm Hg
•The subject who have been injured near the knee joint region in the past six months.
•Subject with a history of knee surgery, replacement, or any non-knee surgical procedures that may impact the study outcomes.
•The subject who have used Intra-articular injections and or steroids for joint health issues in the last six months. The subjects who have undergone a significant cardiovascular event in the past six months.
•The subject who has undergone a significant cardiovascular event in the past six months.
•History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders, that in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk.
•The subject who have any other chronic disease or condition or inflammatory disease conditions and/ or are using any medication or dietary supplements or ayurvedic medications or topical ointment/oil/gel for joint health that in the judgment of the Investigator would put the subject at unacceptable risk the for the subject in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
•Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
•The subject who have participated in a study of an investigational product 90 days prior to the screening.
•Subject with a history of heavy alcohol consumption.
•Subject currently on joint health supplements for pain or inflammation.