FatigueNCT05621395
To Study the Effect of Investigational Product on Fatigue and Cardiorespiratory Fitness in Healthy Adults.
A study testing E-OJ-01 and Microcrystalline cellulose in people with Fatigue, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- E-OJ-01 and Microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 4 sitesIndia
- Study dates
- 29 Nov 2022to 4 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Jaipur National University Institute for Medical Science and Research Centre
Jaipur, Rajasthan, 302017
D.Y. Patil deemed to be University,
Nerul, Maharashtra, 400706
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, 400607
Shree Ashirwad Hospital
Thane, Maharashtra, 421207
About this study
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.
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.
- Conditions
- Fatigue
- Being tested
- E-OJ-01, Microcrystalline cellulose
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-OJ-01Other
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
Microcrystalline celluloseOther
1 capsule (400 mg) orally to be taken after breakfast daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| E-OJ-01 | Experimental | 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days Receives: Other: E-OJ-01 |
| Microcrystalline cellulose | Placebo comparator | 1 capsule (400 mg) orally to be taken after breakfast daily for 60 days Receives: Other: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 baseline to Day 60
Secondary outcomes (6)
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.
Measured: Day 0 and Day 60
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
Measured: Day 0 and Day 60
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.
Measured: Day 0, Day 15, Day 30 and Day 60
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.
Measured: Day 0, Day 15, Day 30 and Day 60
Heart rate at maximal fatigue
Higher the percentile superior is the health
Measured: Day 0 and Day 60
Mitochondrial biogenesis
Energy balance as assessed by serum PGC-1α levels, a marker of mitochondrial biogenesis.
Measured: Day 0 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start29 Nov 2022
- Primary completion4 Sep 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Parallel Group, Placebo Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Shalini Srivastava, MD medicine, Study director, Vedic Lifesciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621395
- Sponsor's protocol ID
- EB/220604/OXY/FATIGUE
- Status last verified
- Sep 2023
- First submitted
- 1 Nov 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05621395
- Acronym / sponsor ID
- EB/220604/OXY/FATIGUE
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized, Parallel Group, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| E-OJ-01 | Experimental | Other: E-OJ-011 capsule (400 mg) orally to be taken after breakfast daily for 60 days |
| Microcrystalline cellulose | Placebo comparator | Other: Microcrystalline cellulose1 capsule (400 mg) orally to be taken after breakfast daily for 60 days |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-OJ-011 capsule (400 mg) orally to be taken after breakfast daily for 60 days | Other | E-OJ-01 |
| Microcrystalline cellulose1 capsule (400 mg) orally to be taken after breakfast daily for 60 days | Other | Microcrystalline cellulose |
Primary outcome
Exercise capacity
Time frame: Day 0 baseline to Day 60
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.
6 secondary outcomes
Cardiorepiratory fitness
Time frame: Day 0 and Day 60
Exercise-induced fatigue and energy levels
Time frame: Day 0 and Day 60
General fatigue
Time frame: Day 0, Day 15, Day 30 and Day 60
Physical fatigue
Time frame: Day 0, Day 15, Day 30 and Day 60
Heart rate at maximal fatigue
Time frame: Day 0 and Day 60
Mitochondrial biogenesis
Time frame: Day 0 and Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
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Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
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Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Shalini Srivastava, MD medicine study director
Vedic Lifesciences Pvt. Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-OJ-01 and Microcrystalline cellulose in people with Fatigue, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: Day 0 baseline to Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.