Clinical trial NCT05825222: A Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
Official title: A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 157
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Parallel Group, Placebo Controlled Trial
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: 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.
timeFrame: Day 90
measure: 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.
timeFrame: Day 60
measure: 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.
timeFrame: Day 30
Secondary outcomes:
measure: 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.
timeFrame: Day 7, 30, and 90
measure: 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.
timeFrame: Day 90
measure: 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.
timeFrame: Day 30 and 90
measure: To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on Rescue Medication consumption.
timeFrame: Day 30 and 90
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Proactive Orthopedic Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Ayush Nursing Home
state: Maharashtra
city: Mumbai
country: India
facility: Diamond Orthopedic Multispeciality Hospital
state: Maharashtra
city: Nashik
country: India
facility: Sankalp Ortho Clinic
state: Maharashtra
city: Nashik
country: India
facility: O2 Clinic Orthopaedics and Opthalmology
state: Maharashtra
city: Panvel
country: India
facility: Sparsh Hospital
state: Maharashtra
Study officials:
affiliation: Vedic Lifesciences Pvt. Ltd.
name: Dr. Shalini Srivastava, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: