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

Vedic Lifesciences Pvt. Ltd.6 sites in 1 country157 target enrollmentApril 28, 2023

ConditionsJoint Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Joint Pain
Sponsor: Vedic Lifesciences Pvt. Ltd.
Enrollment: 157
Locations: 6
Primary Endpoint: 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.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 28, 2023

End Date

January 17, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vedic Lifesciences Pvt. Ltd.

Responsible Party

Sponsor

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/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.

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).

Outcomes

Primary Outcomes

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.

Time Frame: 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.

Secondary Outcomes

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)