NCT05825222已完成不适用
A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 12
- 主要终点
- To evaluate the effect of E-PR-01 (Low Dose and High Dose) on the musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ) compared to baseline and placebo.
研究概览
简要总结
The present study is a randomized, placebo-controlled, parallel-group, double-blind (double-dummy) clinical study. Not more than 210 individuals will be screened, and considering a screening failure rate of 18%, approximately 168 participants will be randomized in a ratio of 1:1:1 to receive E-PR-01 (LD: 200 mg/day), E-PR-01 (HD: 400 mg/day), or placebo (400 mg/day). After accounting for a dropout/withdrawal rate of 15%, each group will have at least 48 completed participants with equal numbers of participants having knee and lumbo-sacral as index joint. The intervention duration for all the study participants will be approximately 90 days.
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
Stratified block randomization, Sequentially numbered, sealed, opaque envelopes
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males & females aged 40-60 years with history of knee and/or low back pain aggravation on physical stress (squatting, walking, running, and cycling) for at least 3 months and maximum up to 3 years.
- •BMI ≥24.9 to ≤29.9 kg/m
- •Participants with either of the following two criteria:
- •On screening, low back pain score ≥60 on a 100-point P-NRS after completion of 4 sets of five-repetition sit-to-stand test along with radiological evidences of lumbo-sacral degeneration indicated by 2 or more of the following:
- •i. Loss of lordosis ii. Joint space narrowing iii. Presence of osteophytes iv. Bony spurs
- •On screening, knee joint pain score ≥60 on a 100-point P-NRS after completion of 4 sets of five-repetition sit-to-stand test along with radiological evidences of knee degeneration indicated by doubtful narrowing of the joint space, possible osteophytes, or definite small osteophytes, definite narrowing of the joint space.
- •Participants with a score of ≤30 on the MSK-HQ scale.
- •Moderate physical activity level as assessed by International Physical Activity Questionnaire (IPAQ)-Short form.
- •Willingness to participate in the study and comply with the study procedures and required visits.
- •Has the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed.
- •Must be literate and have the ability to complete the study-based questionnaires and tasks.
- •Ready to refrain from intake of analgesics one week prior to screening visit and during the study.
- •Female participants of childbearing age must be willing to use the accepted methods of contraception during the study.
排除标准
- •P-NRS score >40 points on rest.
- •Any other type of pain except joint pain including muscular, nervine or pain due to acute injury.
- •For knee joint, participants with the radiographic evidence of no presence of OA, or multiple moderately sized osteophytes with definite JSN, sclerosis, or definite bony deformity will be excluded.
- •For lumbo-sacral joint, participants with the radiographic evidence of normal, or disc space narrowing with osteophytes, or bone sclerosis, disc space narrowing, large osteophytes will be excluded.
- •Known cases of osteoporosis.
- •Current intake of disease modifying antirheumatic drugs for joint pain.
- •Participants with neurological characteristic of pain (shooting, burning, stabbing, or electric shock-like pain, tingling, numbness, or a "pins and needles" feeling).
- •Participants suffering from insomnia and restless leg syndrome.
- •Participants with uncontrolled hypertension (defined as systolic blood pressure (SBP)≥140 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg despite anti-hypertensive treatment).
- •Participants suffering from uncontrolled type II diabetes mellitus (Random blood glucose (RBG)≥200 mg/dl (11.1 mmol/l) despite anti-diabetic treatment).
- •History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
- •History of hyperacidity with at least one episode/week.
- •History of use of any dietary supplement within 2 weeks of screening visit.
- •Heavy drinkers defined as - for men, consuming more than 4 drinks on any day or more than 14 drinks per week and for women, consuming more than 3 drinks on any day or more than 7 drinks per weekly.
- •Participants who have any other diagnosed disease or condition, or are using any medication, that in the judgment of the investigator would puthim/ her at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with intervention or visits.
- •Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- •Participants who have had participated in a study of an investigational product 90 days prior to the screening.
结局指标
主要结局
To evaluate the effect of E-PR-01 (Low Dose and High Dose) on the musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ) compared to baseline and placebo.
时间窗: Day 30
The MSK-HQ is a short 14 item questionnaire that allows people with musculoskeletal conditions to report their symptoms and quality of life. The total score ranges from 0-56, with 56 being the best possible musculoskeletal health state.
次要结局
- To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on Pain Numeric Rating Scale (P-NRS) compared to baseline and placebo.(Day 7, 30, and 90)
- To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on Rescue Medication consumption.(Day 30 and 90)
- To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on Quality of life (QoL) compared to baseline and placebo.(Day 30 and 90)
- To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on Range of motion (ROM) of the index joint compared to baseline and placebo.(Day 90)
研究者
研究点 (12)
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