CTRI/2023/03/051157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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 6
- 主要终点
- To evaluate the effect of E-PR-01 (LD and HD) 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
A study has already been done with this product on participants with low back pain. This study is being done to see the efficacy of the product on low back pain/ knee joint pain in physically active individuals.
The study design is a randomized, placebo-controlled, parallel-group, double-blind (double-dummy) study. Approximately 168 participants will be randomized in a ratio of 1:1:1 to receive E-PR-01 (Low Dose), E-PR-01 (High Dose), or Placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will be included in the study if they fulfil each of the below-mentioned criteria:
- •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 atleast 3 months and maximum up to 3 years.
- •BMI more than or equal to 24.9 to less than or equal to 29.9 kg/m
- •Participants with either of the following two criteria: a. On screening, low back pain score more than equal to 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:.
- •Loss of lordosis.
- •Joint space Narrowing.
- •Presence of osteophytes.
- •Bony spurs b. On screening, knee joint pain score more than or equal to 60 on a 100 point P-NRS after completion of 4 sets of five-repetition-sit-to-stand test along with radiological evidence of knee degeneration indicated by doubtful narrowing of the joint space, possible osteophytes, or definite small osteophytes, definite narrowing of joint space.
- •Participants with a score of less than or equal to 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
- •Participants will be excluded from the study if they fulfil any of the following criteria: 1.P-NRS score more than 40 points on rest. 2.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, and large osteophytes will be excluded. 5.Known cases of osteoporosis. 6.Current intake of disease-modifying osteoarthritis/antirheumatic drugs for joint pain. 7.Participants with neurological characteristic of pain (shooting, burning, stabbing, or electric shock-like pain, tingling, numbness, or a “pins and needles†feeling). 8.Participants suffering from insomnia and restless leg syndrome. 9.Participants with uncontrolled hypertension (defined as SBP more than or equal to 140 mm Hg and/or DBP more than or equal to 90 mm Hg despite anti-hypertensive treatment). 10.Participants suffering from uncontrolled type II diabetes mellitus (RBG ≥200 mg/dl [11.1 mmol/l] despite anti-diabetic treatment). 11.History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders. 12.History of hyperacidity with at least one episode/week. 13.History of use of any dietary supplement within 2 weeks of screening visit. 14.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. 15.Participants who have any other diagnosed disease or condition, or are using any medication, that in the judgment of the investigator would put him/ her at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with intervention or visits. 16.Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 17.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 (LD and HD) on the musculoskeletal health as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ) compared to baseline and placebo
时间窗: Day 90
次要结局
- Pain numeric rating scale (P-NRS) score after 2 sets of five-repetition sit-to-stand test compared to baseline and placebo(Day 90)
- Range of motion (ROM) of the index joint compared to baseline and placebo(Day 90)
- Quality of life (QoL) as assessed by the change in Euro QoL 5 dimension 5 level (EQ-5D-5L) questionnaire score compared to baseline and placebo(Day 90)
- Proportion of participants who used rescue medication (RM) during the study compared to placebo(Day 90)
研究者
研究点 (6)
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