A Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
Study Details
Study Description
Brief Summary
The present study is a randomized, placebo-controlled, parallel-group,double-blind (double-dummy) clinical study. Approximately 168 participants will be randomized in a ratio of 1:1:1 to receive E-PR-01 (Low Dose), E-PR-01 (High Dose), or Placebo .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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. [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. [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. [Day 30]
Secondary Outcome Measures
- To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on: [Day 7, 30, and 90]
Pain numeric rating scale (P-NRS) score after 4 sets of five-repetition sit-to-stand test compared to baseline and placebo.
- To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on: [Day 90]
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.
- To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on: [Day 30 and 90]
Quality of life (QoL) as assessed by the change in Euro QoL 5 dimension 5 level (EQ-5D-5L) questionnaire score compared to baseline and placebo.
- To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on: [Day 30 and 90]
Proportion of participants who used rescue medication (RM) during the study compared to placebo.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males & females aged 40-60 years with history of knee and/or hip joint pain aggravation on physical stress (squatting, walking, running, and cycling) for at least 3 months and maximum up to 3 years.
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BMI ≥24.9 to ≤29.9 kg/m2.
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On screening, joint pain score ≥60 on a 100-point P-NRS after completion of 2 sets of five-repetition sit-to-stand test.
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Moderate physical activity level as assessed by International Physical Activity Questionnaire (IPAQ)-Short form.
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Willingness to participate in the study and comply with the study procedures and required visits.
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Has the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed.
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Must be literate and have the ability to complete the study-based questionnaires and tasks.
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Ready to refrain from intake of analgesics one week prior to screening visit and during the study.
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Female participants of childbearing age must be willing to use the accepted methods of contraception during the study.
Exclusion Criteria:
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P-NRS score >40 points on rest.
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Any other type of pain except joint pain including muscular, nervine or pain due to acute injury.
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Participants with the radiographic evidence of multiple moderately sized osteophytes with definite JSN, sclerosis, or definite bony deformity.
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Known cases of osteoporosis.
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Current intake of disease modifying antirheumatic drugs for joint pain.
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Participants with neurological characteristic of pain (shooting, burning, stabbing, or electric shock-like pain, tingling, numbness, or a "pins and needles" feeling).
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Participants suffering from insomnia and restless leg syndrome.
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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).1
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Participants suffering from uncontrolled type II diabetes mellitus (Random blood glucose (RBG)≥200 mg/dl (11.1 mmol/l) despite anti-diabetic treatment)
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History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
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History of hyperacidity with at least one episode/week.
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History of use of any dietary supplement within 2 weeks of screening visit.
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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.
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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.
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Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
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Participants who have had participated in a study of an investigational product 90 days prior to the screening.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Proactive Orthopedic Clinic | Mumbai | Maharashtra | India | 400053 |
| 2 | Ayush Nursing Home | Mumbai | Maharashtra | India | 400067 |
| 3 | Life Care Hospital | Nashik | Maharashtra | India | 422009 |
| 4 | Sparsh Hospital | Panvel | Maharashtra | India | 410206 |
Sponsors and Collaborators
- Vedic Lifesciences Pvt. Ltd.
Investigators
- Principal Investigator: Dr. Shalini Srivastava, MBBS, MD, Vedic Lifesciences Pvt. Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EB/221202/MUV/JP