To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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
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Individuals with a history of any pulmonary disorder.
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Known cases of hypertension and diabetes mellitus.
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SpO2 < 96%
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Random blood glucose (RBG) levels ≥140 mg/dl.
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Hemoglobin (Hb) <13.0 g/dl.
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Abnormal thyroid stimulating hormone (TSH) value (<0.4μIU/ml or >4.2μIU/ml).
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Individuals with a history of COVID-19 in the last 3 months.
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Individuals currently on/or having a history of taking blood lipid-lowering medications.
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Individuals who are unable to run due to any joint disorder.
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History of smoking or active smokers using any form of tobacco.
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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.
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Individuals who are currently on dietary supplements.
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Individuals who are currently on diuretics.
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History/symptoms of any cardiovascular disorder such as coronary artery disease or myocardial infarction.
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Individuals having clinically significant illnesses of the endocrine, immune, gastrointestinal, hepatobiliary, kidney, urinary, hematological, musculoskeletal system, and/or any inflammatory disorder.
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History of any significant neurological and psychiatric condition, which may affect the participation and inference of the studys endpoints.
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Participation in other clinical trials in the last 90 days before screening.
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
74 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Central trial contact
Dr Sonali Ghosh, BAMS; Dr Shalini Srivastava, MD medicine
Data sourced from clinicaltrials.gov
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