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

NCT05825222 | Completed

• 1 other identifier: EB/221202/MUV/JP
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 6

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.

Conditions

Joint Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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 Range of motion (ROM) of the index joint compared to baseline and placebo.

  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.

  Day 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

Study Arms (3)

E-PR-01 (Low Dose)

ACTIVE COMPARATOR

One capsule twice a day

Dietary Supplement: E-PR-01 (Low dose)

E-PR-01 (High Dose)

ACTIVE COMPARATOR

One capsule twice a day

Dietary Supplement: E-PR-01 (High Dose)

Placebo

PLACEBO COMPARATOR

One capsule twice a day

Dietary Supplement: Placebo

Interventions

E-PR-01 (Low dose) DIETARY_SUPPLEMENT

One Capsule to be consumed twice a day

E-PR-01 (Low Dose)

E-PR-01 (High Dose) DIETARY_SUPPLEMENT

One Capsule to be consumed twice a day

E-PR-01 (High Dose)

Placebo DIETARY_SUPPLEMENT

One Capsule to be consumed twice a day

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (6)

Proactive Orthopedic Clinic

Mumbai, Maharashtra, 400053, India

Location

Ayush Nursing Home

Mumbai, Maharashtra, 400067, India

Location

Diamond Orthopedic Multispeciality Hospital

Mumbai, Maharashtra, 400067, India

Location

Sankalp Ortho Clinic

Nashik, Maharashtra, 422002, India

Location

O2 Clinic Orthopaedics and Opthalmology

Nashik, Maharashtra, 422005, India

Location

Sparsh Hospital

Panvel, Maharashtra, 410206, India

Location

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Shalini Srivastava, MBBS, MD

  Vedic Lifesciences Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Stratified block randomization, Sequentially numbered, sealed, opaque envelopes
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Group, Placebo Controlled Trial

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 24, 2023
• Study Start: April 28, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: February 8, 2024

Record last verified: 2023-10

Locations

IN (6)