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A Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics

Primary Purpose

Endothelial Function

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Moringa oleifera (E-HS-01)
Placebo
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Endothelial Function

Eligibility Criteria

20 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy, physically active male volunteers aged between 20 to 35 years.
  2. Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
  3. Participants with low to moderate physical activity as defined by a six-point scale score of ≥1 to ≤ 4.
  4. Participants with systolic blood pressure (SBP) ≤ 139 and diastolic blood pressure (DBP) ≤ 89 mm Hg.
  5. Ability to read and provide written, personally signed, and dated informed consent to participate in the study.
  6. Ready to abstain from alcohol, caffeine, and vigorous physical activity (as assessed by six point scale) for 24 hours prior to every study visit.
  7. Ready to abstain from beet root, moringa, and spinach for 48 hours prior to every study visit.

Exclusion Criteria:

  1. Participants with history of pulmonary disorders (asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pneumonia, etc)
  2. Participants having fasting blood glucose (FBG) levels ≥ 125 mg/dL.
  3. Participants currently on/or having history of taking antihypertensives / diuretics.
  4. Smokers and tobacco users.

  5. 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).

  6. Participants currently on performance enhancing supplements.
  7. History/symptoms of coronary artery disease, myocardial infarction etc.
  8. 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.

Sites / Locations

  • Vedic LifesciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Moringa oleifera (E-HS-01)

Placebo

Arm Description

One capsule to be taken stat

One capsule to be taken stat

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 4, 2021
Last Updated
February 21, 2022
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05002881
Brief Title
A Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, Double-blind, Cross-over, Placebo controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind, Cross-over
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moringa oleifera (E-HS-01)
Arm Type
Active Comparator
Arm Description
One capsule to be taken stat
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One capsule to be taken stat
Intervention Type
Other
Intervention Name(s)
Moringa oleifera (E-HS-01)
Intervention Description
One capsule to be taken stat
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
One capsule to be taken stat
Primary Outcome Measure Information:
Title
Percent flow mediated dilatation
Description
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.
Time Frame
From baseline (pre-IP administration) to 3 hours post-IP administration
Secondary Outcome Measure Information:
Title
Blood flow velocity
Description
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.
Time Frame
at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration
Title
Percent flow mediated dilatation
Description
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.
Time Frame
at 1, and 2 hours post-IP administration from baseline (pre-IP administration)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Shalini Dr. Srivastava, MD - Medicine
Phone
022 42172326
Ext
326
Email
shalini.s@vediclifesciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mr. Zubair Ansari, M pharm
Phone
7738945639
Email
zubair@vediclifesciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr, Anjali Jain, BHMS
Organizational Affiliation
Vedic lifesciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vedic Lifesciences
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400053
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Anjali Jain, BHMS
First Name & Middle Initial & Last Name & Degree
zubair Ansari, Mpharm
Phone
7738945639
Email
zubair@vediclifesciences.com

12. IPD Sharing Statement

Learn more about this trial

A Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics

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