a study to evaluate the efficacy of e-pr-01 on musculoskeletal health in physically active individuals

Conditions: Joint Pain

Summary: 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.


Eligibility criteria:
inclusion 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 at least 3 months and maximum up to 3 years. * bmi ≥24.9 to ≤29.9 kg/m2. * participants with either of the following two criteria: 1. 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 2. 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. exclusion criteria: * 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.