None listed
Conditions
Interventions
Intervention1: HP426 (Hovenia dulcis Thunb. extract): Dose: 430 mg per capsule
Dosage form: Capsule
Frequency: Take 6 Capsules, 1 to 3-time daily with water, Take anytime
Route of administration: Oral
Sponsors
Syncorp Health Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged 30 to 59 who feel fatigued 2. FSS score of 28 points or higher 3. A person who has agreed to participate in this clinical trial before its start and has signed the written Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: 1. Those who are unable to perform cycle ergo meter 2. Smokers, alcoholics, drug addicts, vegetarians 3. Individuals with a high level of cardiopulmonary endurance (top 50 percentage of 1st and 2nd maximal oxygen consumption by age and sex) 4. Those with a BMI of 18.5 kg per meter square or less and 29.9 kg per meter square or more. 5. Those who have undergone surgical operation within the first 6 months of the first visit. 6. Those who have continuously consumed health functional foods or herbal medicines within the first month of the first visit. 7. Those who have hyperlipidemia, asthma, diabetes, bronchitis, anemia, thyroid disease, cardiovascular disease (hypertension, stroke, heart failure, etc.),kidney disease, liver disease, musculoskeletal disorder, nervous system disease, or those who have had a history of it, and those who are taking related medications. 8. Subject who constantly exercised (moderate or high intensity) for 3 months prior to the first visit. 9. Those who are hypersensitive to ingredients contained in the test product or test food. 10. Those who have difficulty recording their diet. 11. Subjects who consumed functional foods or related food to affect physical performance and fatigue (health supplements, fatigue recover supplements and so on.) 12. Subject who are pregnant or lactating women. 13. Those who are legally prohibited from participating in clinical trials. 14. Those who are currently participating in another clinical trial under research and development other than this clinical trial, or those who have participated in another clinical trial within 1 month prior to the trial. 15. Those who are likely to be uncooperative with this clinical trial or those who the researcher determines are unable to proceed with the trial. 16. Those with Insomnia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale (FSS) Score ImprovementTimepoint: Screening, Baseline, Week 4 and Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Level reduction in Creatine Kinase (CK), Lactate, Lactate dehydrogenase (LDH), Cortisol, Serotonin, MalondialdehydeTimepoint: Baseline & Week 8;Improvement in the following exercise indicator by cycle ergometer: VO2 max, Time to exhaustion, Distance to exhaustion, Maximal heart rate, anaerobic threshold, Multidimensional Fatigue Inventory.Timepoint: Baseline & Week 8;Safety assessment of the investigational product (IP) compared to placeboTimepoint: Baseline and Week 8 | — |
Countries
India
Contacts
Public ContactArabinda Patnaik
Syncorp Health Pvt Ltd
Outcome results
None listed