Joint PainNCT05825222
A Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
A study testing E-PR-01 (Low dose) and E-PR-01 (High Dose) in people with Joint Pain, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
Trial 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)… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Joint Pain
- What is being tested?
- E-PR-01 (Low dose) and E-PR-01 (High Dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 6 sitesIndia
- Study dates
- 28 Apr 2023to 17 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- 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.
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- 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.
Who cannot join
- 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.
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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).
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Proactive Orthopedic Clinic
Mumbai, Maharashtra, 400053
Ayush Nursing Home
Mumbai, Maharashtra, 400067
Diamond Orthopedic Multispeciality Hospital
Mumbai, Maharashtra, 400067
Sankalp Ortho Clinic
Nashik, Maharashtra, 422002
O2 Clinic Orthopaedics and Opthalmology
Nashik, Maharashtra, 422005
Sparsh Hospital
Panvel, Maharashtra, 410206
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
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
- Being tested
- E-PR-01 (Low dose), E-PR-01 (High Dose), Placebo
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-PR-01 (Low dose)Dietary supplement
One Capsule to be consumed twice a day
E-PR-01 (High Dose)Dietary supplement
One Capsule to be consumed twice a day
PlaceboDietary supplement
One Capsule to be consumed twice a day
| Study group | Role | What they receive |
|---|---|---|
| E-PR-01 (Low Dose) | Active comparator | One capsule twice a day Receives: Dietary Supplement: E-PR-01 (Low dose) |
| E-PR-01 (High Dose) | Active comparator | One capsule twice a day Receives: Dietary Supplement: E-PR-01 (High Dose) |
| Placebo | Placebo comparator | One capsule twice a day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 30
Secondary outcomes (4)
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").
Measured: 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.
Measured: 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'.
Measured: 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.
Measured: Day 30 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start28 Apr 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel Group, Placebo Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Shalini Srivastava, MBBS, MD, Principal investigator, Vedic Lifesciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825222
- Sponsor's protocol ID
- EB/221202/MUV/JP
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of E-PR-01 on Musculoskeletal Health in Physically Active Individuals
- ClinicalTrials.gov ID
- NCT05825222
- Acronym / sponsor ID
- EB/221202/MUV/JP
- Conditions
- Joint Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, Parallel Group, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| E-PR-01 (Low Dose) | Active comparator | Dietary Supplement: E-PR-01 (Low dose)One capsule twice a day |
| E-PR-01 (High Dose) | Active comparator | Dietary Supplement: E-PR-01 (High Dose)One capsule twice a day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne capsule twice a day |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-PR-01 (Low dose)One Capsule to be consumed twice a day | Dietary supplement | E-PR-01 (Low Dose) |
| E-PR-01 (High Dose)One Capsule to be consumed twice a day | Dietary supplement | E-PR-01 (High Dose) |
| PlaceboOne Capsule to be consumed twice a day | Dietary supplement | Placebo |
Primary outcome
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.
Time frame: Day 90
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.
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.
Time frame: Day 60
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.
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.
Time frame: Day 30
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.
4 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 30 and 90
To evaluate the effect of 90 days' administration of E-PR-01 (LD and HD) on Rescue Medication consumption.
Time frame: Day 30 and 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Shalini Srivastava, MBBS, MD principal investigator
Vedic Lifesciences Pvt. Ltd.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-PR-01 (Low dose) and E-PR-01 (High Dose) in people with Joint Pain, run by Vedic Lifesciences Pvt. Ltd. at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 90). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.