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

NCT ID: NCT05825222

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2024-01-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

E-PR-01 (Low Dose)

One capsule twice a day

Group Type: ACTIVE_COMPARATOR

E-PR-01 (Low dose)

Intervention Type: DIETARY_SUPPLEMENT

One Capsule to be consumed twice a day

E-PR-01 (High Dose)

One capsule twice a day

Group Type: ACTIVE_COMPARATOR

E-PR-01 (High Dose)

Intervention Type: DIETARY_SUPPLEMENT

One Capsule to be consumed twice a day

Placebo

One capsule twice a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

One Capsule to be consumed twice a day

Interventions

E-PR-01 (Low dose)

One Capsule to be consumed twice a day

Intervention Type: DIETARY_SUPPLEMENT

E-PR-01 (High Dose)

One Capsule to be consumed twice a day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

One Capsule to be consumed twice a day

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Shalini Srivastava, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Vedic Lifesciences Pvt. Ltd.

Locations

Proactive Orthopedic Clinic

Mumbai, Maharashtra, India

Ayush Nursing Home

Mumbai, Maharashtra, India

Diamond Orthopedic Multispeciality Hospital

Mumbai, Maharashtra, India

Sankalp Ortho Clinic

Nashik, Maharashtra, India

O2 Clinic Orthopaedics and Opthalmology

Nashik, Maharashtra, India

Sparsh Hospital

Panvel, Maharashtra, India

Countries

India

Other Identifiers

EB/221202/MUV/JP

Identifier Type: -

Identifier Source: org_study_id