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To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
E-OJ-01
Microcrystalline cellulose
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatigue

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy males aged ≥30 to ≤60 years. Body mass index (BMI) ≥18 and ≤29.9 kg/m2 VO2 max ≥20 ml/kg/ min but ≤35 ml /min/kg. FAS total score ≥22. Systolic blood pressure (SBP) ≤130 mm Hg and diastolic blood pressure (DBP) ≤89 mm Hg. Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit. Individuals who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule). Individuals who are literate enough to understand the purpose of the study and their rights. Individuals who can give written informed consent and are willing to participate in the study. Exclusion Criteria: Individuals with a history of any pulmonary disorder. Known cases of hypertension and diabetes mellitus. SpO2 < 96% Random blood glucose (RBG) levels ≥140 mg/dl. Hemoglobin (Hb) <13.0 g/dl. Abnormal thyroid stimulating hormone (TSH) value (<0.4μIU/ml or >4.2μIU/ml). Individuals with a history of COVID-19 in the last 3 months. Individuals currently on/or having a history of taking blood lipid-lowering medications. Individuals who are unable to run due to any joint disorder. History of smoking or active smokers using any form of tobacco. Individuals with substance abuse problems (within two years) defined as: Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence. High-risk drinking as defined as consuming 5 or more alcohol-containing drinks on any day or 15 or more alcohol-containing drinks per week. Individuals who are currently on dietary supplements. Individuals who are currently on diuretics. History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction. Individuals having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder. History of any significant neurological and psychiatric condition, which may affect the participation and inference of the studys endpoints. Participation in other clinical trials in the last 90 days before screening. Any condition that could, in the opinion of the Investigator, preclude the participants ability to successfully and safely complete the study or may confound study outcomes.

Sites / Locations

  • D.Y. Patil deemed to be University,
  • Shree Ashirwad Hospital
  • Dr. Preeti Bawaskar's Clinic
  • Jaipur National University Institute for Medical Science and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

E-OJ-01

Microcrystalline cellulose

Arm Description

1 capsule (400 mg) orally to be taken after breakfast daily for 60 days

1 capsule (400 mg) orally to be taken after breakfast daily for 60 days

Outcomes

Primary Outcome Measures

Exercise capacity
To determine the effect of 60 days of product on exercise capacity as assessed by change in time-to-exhaustion (TTE) as evaluated by the Borg RPE scale while running on a treadmill using the Modified Bruce treadmill test protocol compared to the placebo. It is a 15-point single-item scale ranging from 6 to 20, with anchors ranging from 6 "No exertion" to 20 "Maximum exertion"The Borg Score of ≥ 19 will indicate the point of volitional exhaustion, and the exercise protocol will be terminated at this point.

Secondary Outcome Measures

Cardiorepiratory fitness
The most accurate assessment of VO2 max is made by measuring expired air composition and respiratory volume during maximal exertion. VO2 max can be estimated from the peak exercise intensity during a maximal exercise test. The primary criterion for attaining VO2 max is a plateau in VO2. Several secondary criteria exist in the case of a plateau in VO2 not being reached, which include a rise in respiratory exchange ratio above 1.0 depending on the age, blood lactate concentration above 8 mmol/l, and an increase in heart rate to the age-predicted maximum.
Exercise-induced fatigue and energy levels
The Visual Analog Scale for energy is anchored with the verbal cues "low" and "high", while VAFS is anchored with the verbal cues "no fatigue" and "very severe fatigue". A higher score indicates higher energy and fatigue on the respective scales
General fatigue
The scale score is calculated by summing all items. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. A total FAS score < 22 indicates no fatigue, and a score ≥ 22 indicates fatigue.The Minimal Clinically Important Difference (MCID) of at least 4 points or 10% change of the baseline value has been reported in cases of sarcoidosis.
Physical fatigue
The scale score is calculated by summing all items. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. A total FAS score < 22 indicates no fatigue, and a score ≥ 22 indicates fatigue.The Minimal Clinically Important Difference (MCID) of at least 4 points or 10% change of the baseline value has been reported in cases of sarcoidosis.
Heart rate at maximal fatigue
Higher the percentile superior is the health
Mitochondrial biogenesis
Energy balance as assessed by serum PGC-1α levels, a marker of mitochondrial biogenesis.

Full Information

First Posted
November 1, 2022
Last Updated
September 7, 2023
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05621395
Brief Title
To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
Official Title
A Randomized, Double-blind, Placebo-Controlled Study to Explore the Effect of E-OJ-01 on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
September 4, 2023 (Actual)
Study Completion Date
September 4, 2023 (Actual)

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
E-OJ-01 (Oxyjun®), a proprietary, standardized aqueous extract of TA, has been proven to improve cardiac output and thereby lead to better oxygenation capacity and exercise endurance. This, in turn, averts fatigue and improves physical functioning. Based on the previous studies of E-OJ-01 and the scientific literature available in support of the antioxidant and anti- inflammatory activity of TA bark, in the present study, it is hypothesized that E-OJ-01 will be able to reduce fatigue and improve the cardiorespiratory fitness of the male participants aged between 30 to 60 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Parallel Group, Placebo Controlled Trial
Masking
ParticipantCare Provider
Masking Description
Sequentially numbered, sealed, opaque envelopes
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-OJ-01
Arm Type
Experimental
Arm Description
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Arm Title
Microcrystalline cellulose
Arm Type
Placebo Comparator
Arm Description
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Intervention Type
Other
Intervention Name(s)
E-OJ-01
Intervention Description
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Intervention Type
Other
Intervention Name(s)
Microcrystalline cellulose
Intervention Description
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Primary Outcome Measure Information:
Title
Exercise capacity
Description
To determine the effect of 60 days of product on exercise capacity as assessed by change in time-to-exhaustion (TTE) as evaluated by the Borg RPE scale while running on a treadmill using the Modified Bruce treadmill test protocol compared to the placebo. It is a 15-point single-item scale ranging from 6 to 20, with anchors ranging from 6 "No exertion" to 20 "Maximum exertion"The Borg Score of ≥ 19 will indicate the point of volitional exhaustion, and the exercise protocol will be terminated at this point.
Time Frame
Day 0 baseline to Day 60
Secondary Outcome Measure Information:
Title
Cardiorepiratory fitness
Description
The most accurate assessment of VO2 max is made by measuring expired air composition and respiratory volume during maximal exertion. VO2 max can be estimated from the peak exercise intensity during a maximal exercise test. The primary criterion for attaining VO2 max is a plateau in VO2. Several secondary criteria exist in the case of a plateau in VO2 not being reached, which include a rise in respiratory exchange ratio above 1.0 depending on the age, blood lactate concentration above 8 mmol/l, and an increase in heart rate to the age-predicted maximum.
Time Frame
Day 0 and Day 60
Title
Exercise-induced fatigue and energy levels
Description
The Visual Analog Scale for energy is anchored with the verbal cues "low" and "high", while VAFS is anchored with the verbal cues "no fatigue" and "very severe fatigue". A higher score indicates higher energy and fatigue on the respective scales
Time Frame
Day 0 and Day 60
Title
General fatigue
Description
The scale score is calculated by summing all items. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. A total FAS score < 22 indicates no fatigue, and a score ≥ 22 indicates fatigue.The Minimal Clinically Important Difference (MCID) of at least 4 points or 10% change of the baseline value has been reported in cases of sarcoidosis.
Time Frame
Day 0, Day 15, Day 30 and Day 60
Title
Physical fatigue
Description
The scale score is calculated by summing all items. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. A total FAS score < 22 indicates no fatigue, and a score ≥ 22 indicates fatigue.The Minimal Clinically Important Difference (MCID) of at least 4 points or 10% change of the baseline value has been reported in cases of sarcoidosis.
Time Frame
Day 0, Day 15, Day 30 and Day 60
Title
Heart rate at maximal fatigue
Description
Higher the percentile superior is the health
Time Frame
Day 0 and Day 60
Title
Mitochondrial biogenesis
Description
Energy balance as assessed by serum PGC-1α levels, a marker of mitochondrial biogenesis.
Time Frame
Day 0 and Day 60

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy males aged ≥30 to ≤60 years. Body mass index (BMI) ≥18 and ≤29.9 kg/m2 VO2 max ≥20 ml/kg/ min but ≤35 ml /min/kg. FAS total score ≥22. Systolic blood pressure (SBP) ≤130 mm Hg and diastolic blood pressure (DBP) ≤89 mm Hg. Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit. Individuals who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule). Individuals who are literate enough to understand the purpose of the study and their rights. Individuals who can give written informed consent and are willing to participate in the study. Exclusion Criteria: Individuals with a history of any pulmonary disorder. Known cases of hypertension and diabetes mellitus. SpO2 < 96% Random blood glucose (RBG) levels ≥140 mg/dl. Hemoglobin (Hb) <13.0 g/dl. Abnormal thyroid stimulating hormone (TSH) value (<0.4μIU/ml or >4.2μIU/ml). Individuals with a history of COVID-19 in the last 3 months. Individuals currently on/or having a history of taking blood lipid-lowering medications. Individuals who are unable to run due to any joint disorder. History of smoking or active smokers using any form of tobacco. Individuals with substance abuse problems (within two years) defined as: Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence. High-risk drinking as defined as consuming 5 or more alcohol-containing drinks on any day or 15 or more alcohol-containing drinks per week. Individuals who are currently on dietary supplements. Individuals who are currently on diuretics. History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction. Individuals having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder. History of any significant neurological and psychiatric condition, which may affect the participation and inference of the studys endpoints. Participation in other clinical trials in the last 90 days before screening. Any condition that could, in the opinion of the Investigator, preclude the participants ability to successfully and safely complete the study or may confound study outcomes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Shalini Srivastava, MD medicine
Organizational Affiliation
Vedic Lifesciences Pvt. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
D.Y. Patil deemed to be University,
City
Nerul
State/Province
Maharashtra
ZIP/Postal Code
400706
Country
India
Facility Name
Shree Ashirwad Hospital
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
421207
Country
India
Facility Name
Dr. Preeti Bawaskar's Clinic
City
Thāne
State/Province
Maharashtra
ZIP/Postal Code
400607
Country
India
Facility Name
Jaipur National University Institute for Medical Science and Research Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.

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