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

Vedic Lifesciences

Status: Completed

Conditions: Joint Pain

Treatments: Dietary Supplement: Placebo; Dietary Supplement: E-PR-01 (Low dose); Dietary Supplement: E-PR-01 (High Dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05825222

EB/221202/MUV/JP

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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157 participants in 3 patient groups, including a placebo group

E-PR-01 (Low Dose)

Active Comparator group

Description:

One capsule twice a day

Treatment:

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

E-PR-01 (High Dose)

Active Comparator group

Description:

One capsule twice a day

Treatment:

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

Placebo

Placebo Comparator group

Description:

One capsule twice a day

Treatment:

Dietary Supplement: Placebo