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

Fatigue Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621395
• Other study ID #: EB/220604/OXY/FATIGUE
• Status: Completed
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: September 4, 2023

Study information

• Verified date: September 2023
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 4, 2023
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Healthy males aged =30 to =60 years.

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:

1. Individuals with a history of any pulmonary disorder.

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.

Related Conditions & MeSH terms

• Fatigue

Intervention

Other:
• 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

Locations

Country	Name	City	State
India	Jaipur National University Institute for Medical Science and Research Centre	Jaipur	Rajasthan
India	D.Y. Patil deemed to be University,	Nerul	Maharashtra
India	Dr. Preeti Bawaskar's Clinic	Thane	Maharashtra
India	Shree Ashirwad Hospital	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 baseline to Day 60
Secondary	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.	Day 0 and Day 60
Secondary	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	Day 0 and Day 60
Secondary	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.	Day 0, Day 15, Day 30 and Day 60
Secondary	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.	Day 0, Day 15, Day 30 and Day 60
Secondary	Heart rate at maximal fatigue	Higher the percentile superior is the health	Day 0 and Day 60
Secondary	Mitochondrial biogenesis	Energy balance as assessed by serum PGC-1a levels, a marker of mitochondrial biogenesis.	Day 0 and Day 60