Endothelial FunctionNCT05002881
A Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics
A study testing Moringa oleifera (E-HS-01) in people with Endothelial Function, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
The present study is designed to evaluate the modulatory effect of IP on the vascular endothelial function. To assess its vasodilatation potential, change in flow mediated dilation (FMD) and blood flow velocity (BFV) will be assessed in healthy adult male population. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- What is being tested?
- Moringa oleifera (E-HS-01)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 16 Aug 2021to 31 Mar 2022
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, physically active male volunteers aged between 20 to 35 years.
- Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
- Participants with low to moderate physical activity as defined by a six-point scale score of ≥1 to ≤ 4.
- Participants with systolic blood pressure (SBP) ≤ 139 and diastolic blood pressure (DBP) ≤ 89 mm Hg.
- Ability to read and provide written, personally signed, and dated informed consent to participate in the study.
- Ready to abstain from alcohol, caffeine, and vigorous physical activity (as assessed by six point scale) for 24 hours prior to every study visit.
- Ready to abstain from beet root, moringa, and spinach for 48 hours prior to every study visit.
Who cannot join
- Participants with history of pulmonary disorders (asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pneumonia, etc)
- Participants having fasting blood glucose (FBG) levels ≥ 125 mg/dL.
- Participants currently on/or having history of taking antihypertensives / diuretics.
- Smokers and tobacco users.
- Participants with heavy alcohol consumption, defined as more than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
- (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
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- Participants currently on performance enhancing supplements.
- History/symptoms of coronary artery disease, myocardial infarction etc.
- Participants with any other condition which in the view of the investigator is likely to interfere with the study or put the participants at risk.
Trial locations and contacts
1 site in 1 country.
Dr. Shalini Dr. Srivastava, MD - Medicine contact
India1 site, 1 recruiting
- Recruiting
Vedic Lifesciences
Mumbai, Maharashtra, 400053
Dr. Anjali Jain, BHMS
zubair Ansari, Mpharm, 7738945639, zubair@vediclifesciences.com
About this study
Official title: A Randomized, Double-blind, Cross-over, Placebo Controlled Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics
The present study is designed to evaluate the modulatory effect of IP on the vascular endothelial function. To assess its vasodilatation potential, change in flow mediated dilation (FMD) and blood flow velocity (BFV) will be assessed in healthy adult male population.
- Conditions
- Endothelial Function
- Being tested
- Moringa oleifera (E-HS-01), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleifera (E-HS-01)Other
One capsule to be taken stat
PlaceboOther
One capsule to be taken stat
| Study group | Role | What they receive |
|---|---|---|
| Moringa oleifera (E-HS-01) | Active comparator | One capsule to be taken stat Receives: Other: Moringa oleifera (E-HS-01); Other: Placebo |
| Placebo | Placebo comparator | One capsule to be taken stat Receives: Other: Moringa oleifera (E-HS-01); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent flow mediated dilatation
To determine change in the endothelial function after single dose administration of Moringa oleifera as assessed by the change in the Percent flow mediated dilatation of brachial artery, from baseline (pre-IP administration) to 3 hours post IP administration, in comparison to the placebo.
Measured: From baseline (pre-IP administration) to 3 hours post-IP administration
Secondary outcomes (2)
Blood flow velocity
The endothelial function can be assessed by measuring changes in blood flow by intravascular ultrasound. It has been demonstrated that biophysical forces such as flow-derived forces, modulates the vascular structure and function. Endothelium is mechanotransducer, which senses mechanical forces on its surface and the transduces these signals into biochemical signals. There exists a large body of literature regarding the wide spectra of biological signals induced by blood flow in the endothelium.18 Thus to evaluate the effect of Moringa oleifera on hemodynamics, change in blood flow velocity (cm/seconds) will be assessed at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration will be measured.
Measured: at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration
Percent flow mediated dilatation
To identify the onset of effect of the investigational product, the flow mediated dilation at 1, and 2 hours post-IP administration from baseline (pre-IP administration) will be assessed as a secondary outcome.
Measured: at 1, and 2 hours post-IP administration from baseline (pre-IP administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start16 Aug 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies 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, Double-blind, Cross-over, Placebo controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr, Anjali Jain, BHMS, Principal investigator, Vedic lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002881
- Sponsor's protocol ID
- EB/210502/MO/FMD
- Status last verified
- Oct 2021
- First submitted
- 4 Aug 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Cross-over, Placebo Controlled Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics
- ClinicalTrials.gov ID
- NCT05002881
- Acronym / sponsor ID
- EB/210502/MO/FMD
- Conditions
- Endothelial Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 12 Aug 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.
The present study is designed to evaluate the modulatory effect of IP on the vascular endothelial function. To assess its vasodilatation potential, change in flow mediated dilation (FMD) and blood flow velocity (BFV) will be assessed in healthy adult male population.
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, Double-blind, Cross-over, Placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Moringa oleifera (E-HS-01) | Active comparator | Other: Moringa oleifera (E-HS-01), Other: PlaceboOne capsule to be taken stat |
| Placebo | Placebo comparator | Other: Moringa oleifera (E-HS-01), Other: PlaceboOne capsule to be taken stat |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, physically active male volunteers aged between 20 to 35 years.
- Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
- Participants with low to moderate physical activity as defined by a six-point scale score of ≥1 to ≤ 4.
- Participants with systolic blood pressure (SBP) ≤ 139 and diastolic blood pressure (DBP) ≤ 89 mm Hg.
- Ability to read and provide written, personally signed, and dated informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Participants with history of pulmonary disorders (asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pneumonia, etc)
- Participants having fasting blood glucose (FBG) levels ≥ 125 mg/dL.
- Participants currently on/or having history of taking antihypertensives / diuretics.
- Smokers and tobacco users.
- Participants with heavy alcohol consumption, defined as more than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
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 |
|---|---|---|
| Moringa oleifera (E-HS-01)One capsule to be taken stat | Other | Moringa oleifera (E-HS-01), Placebo |
| PlaceboOne capsule to be taken stat | Other | Moringa oleifera (E-HS-01), Placebo |
Primary outcome
Percent flow mediated dilatation
Time frame: From baseline (pre-IP administration) to 3 hours post-IP administration
To determine change in the endothelial function after single dose administration of Moringa oleifera as assessed by the change in the Percent flow mediated dilatation of brachial artery, from baseline (pre-IP administration) to 3 hours post IP administration, in comparison to the placebo.
2 secondary outcomes
Blood flow velocity
Time frame: at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration
Percent flow mediated dilatation
Time frame: at 1, and 2 hours post-IP administration from baseline (pre-IP administration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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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 Dr. Srivastava, MD - Medicine contact
Dr, Anjali Jain, BHMS principal investigator
Vedic lifesciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa oleifera (E-HS-01) in people with Endothelial Function, 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 9 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shalini Dr. Srivastava, MD - Medicine (022 42172326 ext. 326, shalini.s@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent flow mediated dilatation (time frame: From baseline (pre-IP administration) to 3 hours post-IP administration). 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 22 Feb 2022.