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

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

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.

Study Overview

• Status: Completed
• Conditions: Joint Pain
• Intervention / Treatment: Dietary supplement: E-PR-01 (Low dose); Dietary supplement: E-PR-01 (High Dose); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400067
      • Ayush Nursing Home
    • Mumbai, Maharashtra, India, 400053
      • Proactive Orthopedic Clinic
    • Mumbai, Maharashtra, India, 400067
      • Diamond Orthopedic Multispeciality Hospital
    • Nashik, Maharashtra, India, 422002
      • Sankalp Ortho Clinic
    • Nashik, Maharashtra, India, 422005
      • O2 Clinic Orthopaedics and Opthalmology
    • Panvel, Maharashtra, India, 410206
      • Sparsh Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: E-PR-01 (Low Dose); One capsule twice a day	Dietary supplement: E-PR-01 (Low dose); One Capsule to be consumed twice a day
Active Comparator: E-PR-01 (High Dose); One capsule twice a day	Dietary supplement: E-PR-01 (High Dose); One Capsule to be consumed twice a day
Placebo Comparator: Placebo; One capsule twice a day	Dietary supplement: Placebo; One Capsule to be consumed twice a day

What is the study measuring?

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 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 Rescue Medication consumption.	Proportion of participants who used rescue medication (RM) during the study compared to placebo.	Day 30 and 90
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 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

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Investigators: Principal Investigator: Dr. Shalini Srivastava, MBBS, MD, Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: EB/221202/MUV/JP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No