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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-PR-01 (Low Dose) | Active Comparator | One capsule twice a day |
|
| E-PR-01 (High Dose) | Active Comparator | One capsule twice a day |
|
| Placebo | Placebo Comparator | One capsule twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-PR-01 (Low dose) | Dietary Supplement | One Capsule to be consumed twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pain numeric rating scale (P-NRS) score is taken after 4 sets of five-repetition sit-to-stand test. It is a unidimensional measure of pain intensity in adults. It is a single 11-point numeric scale with 0 indicating one pain extreme (eg: "no pain") and 100 indicating the other pain extreme (eg: "worst pain imaginable"). |
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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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Shalini Srivastava, MBBS, MD | Vedic Lifesciences Pvt. Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Proactive Orthopedic Clinic | Mumbai | Maharashtra | 400053 | India | ||
| Ayush Nursing Home |
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| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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Randomized, Parallel Group, Placebo Controlled Trial
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Stratified block randomization, Sequentially numbered, sealed, opaque envelopes
| E-PR-01 (High Dose) |
| Dietary Supplement |
One Capsule to be consumed twice a day |
|
| Placebo | Dietary Supplement | One Capsule to be consumed twice a day |
|
| 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. | This assessment will be done with the use of a manual Goniometer and the angle will be measured in degrees. | 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. | This is assessed by the change in Euro QoL 5 dimension 5 level (EQ-5D-5L) questionnaire score. The EQ VAS records the respondent's self-rated health on a vertical VAS numbered from 0-100 where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | Day 30 and 90 |
| To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on Rescue Medication consumption. | Proportion of participants who used rescue medication (RM) during the study compared to placebo. | Day 30 and 90 |
| Mumbai |
| Maharashtra |
| 400067 |
| India |
| Diamond Orthopedic Multispeciality Hospital | Mumbai | Maharashtra | 400067 | India |
| Sankalp Ortho Clinic | Nashik | Maharashtra | 422002 | India |
| O2 Clinic Orthopaedics and Opthalmology | Nashik | Maharashtra | 422005 | India |
| Sparsh Hospital | Panvel | Maharashtra | 410206 | India |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |