To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
NCT ID: NCT05621395
Last Updated: 2023-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2022-11-29
2023-09-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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E-OJ-01
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
E-OJ-01
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Microcrystalline cellulose
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Microcrystalline cellulose
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Interventions
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E-OJ-01
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Microcrystalline cellulose
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) ≥18 and ≤29.9 kg/m2
3. VO2 max ≥20 ml/kg/ min but ≤35 ml /min/kg.
4. FAS total score ≥22.
5. Systolic blood pressure (SBP) ≤130 mm Hg and diastolic blood pressure (DBP) ≤89 mm Hg.
6. Ready to abstain from alcohol, caffeine, and vigorous physical activity for 24 h before every study visit.
7. Individuals who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule).
8. Individuals who are literate enough to understand the purpose of the study and their rights.
9. Individuals who can give written informed consent and are willing to participate in the study.
Exclusion Criteria
2. Known cases of hypertension and diabetes mellitus.
3. SpO2 \< 96%
4. Random blood glucose (RBG) levels ≥140 mg/dl.
5. Hemoglobin (Hb) \<13.0 g/dl.
6. Abnormal thyroid stimulating hormone (TSH) value (\<0.4μIU/ml or \>4.2μIU/ml).
7. Individuals with a history of COVID-19 in the last 3 months.
8. Individuals currently on/or having a history of taking blood lipid-lowering medications.
9. Individuals who are unable to run due to any joint disorder.
10. History of smoking or active smokers using any form of tobacco.
11. 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.
12. Individuals who are currently on dietary supplements.
13. Individuals who are currently on diuretics.
14. History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction.
15. Individuals having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder.
16. History of any significant neurological and psychiatric condition, which may affect the participation and inference of the studys endpoints.
17. Participation in other clinical trials in the last 90 days before screening.
18. 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.
30 Years
60 Years
MALE
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Shalini Srivastava, MD medicine
Role: STUDY_DIRECTOR
Vedic Lifesciences Pvt. Ltd.
Locations
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D.Y. Patil deemed to be University,
Nerul, Maharashtra, India
Dr. Preeti Bawaskar's Clinic
Thāne, Maharashtra, India
Shree Ashirwad Hospital
Thāne, Maharashtra, India
Jaipur National University Institute for Medical Science and Research Centre
Jaipur, Rajasthan, India
Countries
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Other Identifiers
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EB/220604/OXY/FATIGUE
Identifier Type: -
Identifier Source: org_study_id
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