A Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals

Conditions
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Joint Pain

Intervention / Treatment
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* Dietary Supplement: E-PR-01 (Low dose)
* Dietary Supplement: E-PR-01 (High Dose)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Parallel Group, Placebo Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-PR-01 (Low Dose)<br>One capsule twice a day | Dietary Supplement: E-PR-01 (Low dose)<br>* One Capsule to be consumed twice a day<br>|
| Active Comparator: E-PR-01 (High Dose)<br>One capsule twice a day | Dietary Supplement: E-PR-01 (High Dose)<br>* One Capsule to be consumed twice a day<br>|
| Placebo Comparator: Placebo<br>One capsule twice a day | Dietary Supplement: Placebo<br>* One Capsule to be consumed twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 90 | 
| 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. | 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. | Day 60 | 
| 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. | 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. | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pain numeric rating scale (P-NRS) score is taken after 4 sets of five-repetition sit-to-stand test. It is a unidimensional measure of pain intensity in adults. It is a single 11-point numeric scale with 0 indicating one pain extreme (eg: no pain) and 100 indicating the other pain extreme (eg: worst pain imaginable). | Day 7, 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. | This assessment will be done with the use of a manual Goniometer and the angle will be measured in degrees. | Day 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. | This is assessed by the change in Euro QoL 5 dimension 5 level (EQ-5D-5L) questionnaire score. The EQ VAS records the respondent's self-rated health on a vertical VAS numbered from 0-100 where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | Day 30 and 90 | 
| To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on Rescue Medication consumption. | Proportion of participants who used rescue medication (RM) during the study compared to placebo. | Day 30 and 90 |