Joint PainNCT05052112
Cross-Over Study to Evaluate the Efficacy of E-PR-01 on Activity Induced Joint Pain
A study testing E-PR-01 and E- PR-02 in people with Joint Pain, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
This Clinical trial study for the effect of a product E-PR-01 will be studied for its ability to attain rapid pain relief in the individuals suffering from exercise-induced knee joint pain, as well as determine its sustained effect on pain reduction over a treatment period of five days. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Joint Pain
- What is being tested?
- E-PR-01 and E- PR-02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 9 Sep 2021to 15 Dec 2021
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physically active adults aged ≥20 and ≤60 years with history of knee joint pain aggravation on physical stress (walking, running, cycling etc.).
- Body Mass Index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
- Participants with self-reported joint pain of ≥ 60 on 100 mm VAS scale after walking on treadmill using modified Naughton's protocol.
- Participants with no or minimal pain at rest (≤ 30 mm on VAS scale).
- Participants willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements.
- Participants willing to abstain from the restricted supplements and medications prior to inclusion and throughout the study period.
- Participants with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
Who cannot join
- Known cases of osteo-, rheumatic- or any other form of arthritis.
- Participants fulfilling ≥ 3 of the following ACR criteria:
- Over the age of 50 years ii. Less than 30 minutes of morning stiffness iii. Crepitus on active motion iv. Bony tenderness v. Bony enlargement vi. No palpable warmth at the knee
- Participants suffering from Insomnia and restless leg syndrome.
- Participants with uncontrolled Hypertension, as characterized by Systolic Blood Pressure (SBP) >139 mmHg and Diastolic Blood Pressure >89 mmHg.
- Participants currently on anti-hypertensives
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- Participants suffering from Type II Diabetes Mellitus.
- Participants with history of lower limb injure in the past six months.
- Participants currently on joint health supplements and medications.
- Participants with a history of knee surgery, replacement, or any non-knee surgical procedures that may impact the study outcomes
- Participants who have used Intraarticular injections in the last six months.
- Participants who have undergone a significant cardiovascular event in the past six months.
- Individuals with history of hyperacidity with at least one episode/ week.
- Individuals with diagnosed cases of migraine.
- History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders, that in the judgment of the investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the participant at undue risk.
- Participants who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the participant at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- Participants who have participated in a study of an investigational product 90 days prior to the screening.
- Participants with heavy alcohol consumption, defined as For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
- For women: More than 7 SAD/week or more than 3 SAD in a day.
- Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a 2-hour time frame.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Cross-Over Study to Evaluate the Efficacy of E-PR-01 on Activity Induced Joint Pain
This Clinical trial study for the effect of a product E-PR-01 will be studied for its ability to attain rapid pain relief in the individuals suffering from exercise-induced knee joint pain, as well as determine its sustained effect on pain reduction over a treatment period of five days.
Read the detailed description
The study is a randomized, double-blind, placebo controlled, cross-over study to explore the effect of a product E-PR-01 on joint pain. Approximately 50 participants aged between ≥ 20 and ≤ 60 years will be screened. At least 40 participants will be randomized, and the participants will be crossed over both the IP and placebo arms. A minimum of 32 participants must complete the study, after accounting for the screening failure and dropout /withdrawal rate of 20% each. The duration of each treatment for all the study participants will be 5 days, the washout period between each treatment period being 5 ± 2 days.
The total study period from the first start of treatment visit, inclusive of the washout and treatment periods, is estimated to be 15 days.
- Conditions
- Joint Pain
- Being tested
- E-PR-01, E- PR-02
- 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-01Other
Active arm
E- PR-02Other
Placebo arm
| Study group | Role | What they receive |
|---|---|---|
| E-PR-01 200mg | Active comparator | Oral administration : One capsule to be taken after breakfast and one capsule before dinner for around 5 to 7 days Receives: Other: E-PR-01; Other: E- PR-02 |
| E-PR-02 200mg | Placebo comparator | Oral administration : One capsule to be taken after breakfast and one capsule before dinner for around 5 to7 days Receives: Other: E-PR-01; Other: E- PR-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Meaningful pain relief assed by Visual Analogue scale
To determine the effect of IP after single dose on time taken to achieve meaningful pain relief as assessed by the time taken to have a reduction of at least 40 % from baseline (0-hour post exertion) on a 100-point pain visual analogue scale as compared to placebo..
Measured: From baseline Day 1 for both treatment period
Secondary outcomes (2)
Pain Intensity Difference (PID)
In this study, the Pain VAS will be used as the method of pain intensity assessment. The values of Pain VAS measured right after IP consumption and each specified time intervals will be the value used to assess PID.at 2-, 3- and 4-hours Day 1 as compared to placebo. Minimum score is 0 represent No pain and 100 means worst possible pain.
Measured: At Post IP 2 hour, 3 hour and 4 hours Day 1 of treatment 1 and Post IP 2 hour, 3 hour and 4 hours Day 1 of treatment 2
Sum of Pain Intensity Difference SPID
VAS score will be taken at 0-hour post exertion and at 4 hours post IP consumption after the performance of the modified Naughton Protocol. The summation of the PID values obtained will be used to calculate the sum of Pain Intensity Difference (SPID). Minimum score is 0 represent No pain and 100 means worst possible pain.
SPID (ti-ti+n) = ∑ (PIDi)*(ti+1-ti)
Measured: at 0-hour post exertion and at 4 hours post IP Day 1 of treatment 1 and 0-hour post exertion and at 4 hours post IP Day 1 of treatment 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start9 Sep 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
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
- Crossover
- Model description
- Randomized, Placebo-controlled, Double-blind, Cross-Over Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052112
- Sponsor's protocol ID
- EB/210504/VTZO/JP
- Status last verified
- Apr 2023
- First submitted
- 9 Sep 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Cross-Over Study to Evaluate the Efficacy of E-PR-01 on Activity Induced Joint Pain
- ClinicalTrials.gov ID
- NCT05052112
- Acronym / sponsor ID
- EB/210504/VTZO/JP
- Conditions
- Joint Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 22 Sep 2021 (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.
This Clinical trial study for the effect of a product E-PR-01 will be studied for its ability to attain rapid pain relief in the individuals suffering from exercise-induced knee joint pain, as well as determine its sustained effect on pain reduction over a treatment period of five days.
Detailed description
The study is a randomized, double-blind, placebo controlled, cross-over study to explore the effect of a product E-PR-01 on joint pain. Approximately 50 participants aged between ≥ 20 and ≤ 60 years will be screened. At least 40 participants will be randomized, and the participants will be crossed over both the IP and placebo arms. A minimum of 32 participants must complete the study, after accounting for the screening failure and dropout /withdrawal rate of 20% each. The duration of each treatment for all the study participants will be 5 days, the washout period between each treatment period being 5 ± 2 days.
The total study period from the first start of treatment visit, inclusive of the washout and treatment periods, is estimated to be 15 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Placebo-controlled, Double-blind, Cross-Over Study
| Arm | Type | Receives |
|---|---|---|
| E-PR-01 200mg | Active comparator | Other: E-PR-01, Other: E- PR-02Oral administration : One capsule to be taken after breakfast and one capsule before dinner for around 5 to 7 days |
| E-PR-02 200mg | Placebo comparator | Other: E-PR-01, Other: E- PR-02Oral administration : One capsule to be taken after breakfast and one capsule before dinner for around 5 to7 days |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Physically active adults aged ≥20 and ≤60 years with history of knee joint pain aggravation on physical stress (walking, running, cycling etc.).
- Body Mass Index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
- Participants with self-reported joint pain of ≥ 60 on 100 mm VAS scale after walking on treadmill using modified Naughton's protocol.
- Participants with no or minimal pain at rest (≤ 30 mm on VAS scale).
- Participants willing to complete all the study procedures including study-related questionnaires and tasks, and comply with the study requirements.
Key exclusion criteria (21 listed)
- Known cases of osteo-, rheumatic- or any other form of arthritis.
- Participants fulfilling ≥ 3 of the following ACR criteria:
- Participants suffering from Insomnia and restless leg syndrome.
- Participants with uncontrolled Hypertension, as characterized by Systolic Blood Pressure (SBP) >139 mmHg and Diastolic Blood Pressure >89 mmHg.
- Participants currently on anti-hypertensives
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-01Active arm | Other | E-PR-01 200mg, E-PR-02 200mg |
| E- PR-02Placebo arm | Other | E-PR-01 200mg, E-PR-02 200mg |
Primary outcome
Time to Meaningful pain relief assed by Visual Analogue scale
Time frame: From baseline Day 1 for both treatment period
To determine the effect of IP after single dose on time taken to achieve meaningful pain relief as assessed by the time taken to have a reduction of at least 40 % from baseline (0-hour post exertion) on a 100-point pain visual analogue scale as compared to placebo..
2 secondary outcomes
Pain Intensity Difference (PID)
Time frame: At Post IP 2 hour, 3 hour and 4 hours Day 1 of treatment 1 and Post IP 2 hour, 3 hour and 4 hours Day 1 of treatment 2
Sum of Pain Intensity Difference SPID
Time frame: at 0-hour post exertion and at 4 hours post IP Day 1 of treatment 1 and 0-hour post exertion and at 4 hours post IP Day 1 of treatment 2
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 6 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and E- PR-02 in people with Joint Pain, run by Vedic Lifesciences Pvt. Ltd. at 1 site 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 7 inclusion and 21 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time to Meaningful pain relief assed by Visual Analogue scale (time frame: From baseline Day 1 for both treatment period). 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 6 Apr 2023.