None listed
Conditions
Interventions
Intervention1: DKB-138: The main ingredient is Schizonepeta Spike extract. The capsule is purple in colour. It is 450 mg capsule consisting of 250 mg of Schizonepeta spike extract. Four capsules to be
Sponsors
Dongkook Pharmaceutical
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female individuals aged from 50 to 70 (inclusive of 50, exclusive of 70) 2.BMI 18.5-30.0 kg/m2 (inclusive of 18.5, exclusive of 30.0) 3.Participants who meet the handgrip strength standards for the average value of their both hands. (Men: less than 33kg, Women less than 21kg) (exclusive of 33 and 21) 4.Participants who do not change their lifestyle (participation in a physical activity program or intake of other health supplements that may affect the study during the intervention.) 5.Participants who voluntarily agree to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participants with allergy to the test product 2. Patients with severe lower extremity musculoskeletal anomalies or injuries (Those with spinal cord diseases such as spinal stenosis who have limited gait that requires surgery) 3. Those who have undergone surgery within 6 months of the start of the study 4. Those who have taken drugs or functional food and that affect muscle strength improvement within 2 weeks from the time of screening (protein powder, amino acid supplement, creatine supplement, Schizandra Chinensis Fruit Extract etc.) 5. Those who have participated in an active exercise training program within 3 months of screening. 6. Patients with fragile hip joint fractures 7. People who cannot talk or walk due to dementia or Parkinsonâ??s disease (those with mild symptoms can participate) 8. Those who have been diagnosed with severe cerebrovascular disease (cerebral infraction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infraction, heart failure, arrhythmia), lung disease (chronic obstructive pulmonary disease, etc.) within 3 months screening (However, those who are clinically stable may participate in the trial at the investigatorâ?? discretion) 9. Participants with uncontrolled diabetes mellitus (FBS >126 mg/dI) 10. Depression: Those who are taking medications prescribed from Psychiatry and Neurology for a mental disorder (However, if the patient is taking intermittent medication due to sleep disorder, appropriately treated depression is suitable for the study) 11. Those with liver disease or those with AST or ALT of 3 times or more of the upper limit of the reference range. 12. Those with renal disease or serum creatinine exceeding 2.0 mg/dI. 13. Uncontrolled hypertension (blood pressure >= 160/100 mmHg) 14. Malignant tumor: Those who have had cancer within 5 years or are currently receiving treatment (except for skin tumors other than melanoma) 15. Participants with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse 16. Those who have taken oral steroids or corticosteroids within 4 weeks of screening. 17. Participants who are taking alcohol equal or more than 140g/week 18. Pregnant or lactating participants, or women of childbearing age who are do not agree to use contraception (oral contraceptives, hormones, intrauterine devices, condoms, spermicides) during the trial. 19. Those who have participated in other study within 3 months of screening. 20. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigatorâ??s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Handgrip strength (Jamar dynamometer)Timepoint: Screening, baseline, EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Isokinetic exercise force measurement (quadriceps muscle force) with isokinetic dynamometer 2) Dual energy x-ray absorptiometry (Muscle Mass) 3)Cytokine (TNF-α, IL-1, IL-6) 4) SPPB. Short Physical Performance Battery 5) 5 repetition chair rise testsTimepoint: 1) Baseline, EOT 2) Baseline, EOT 3) Baseline, EOT 4) Baseline, EOT 5) Baseline, EOT;1)Adverse events 2) Vital signs (pulse, body temperature, respiration, and blood pressure) 3) Urinalysis (colour, appearance, pH, and specific gravity, nitrite, and ketone) 4) Blood chemistry (Aspartate Aminotransferase, Alanine Aminotransferase, Gamma-glutamyl transferase, Alkaline phosphatase, Total Bilirubin, Total Protein, Albumin, potassium, calcium, Total Cholesterol, Triglyceride, High Density Lipoprotein Cholesterol, Low Density Lipoprotein Cholesterol, Blood Urea Nitrogen, Creatinine, Uric acid, and Fasting Blood glucose) 5) Complete Blood Count (Red Blood Count, Total Leukocyte Count, differential Leukocyte Count, Platelets, Haemoglobin and Haematocrit) 6) Physical examination 7) BMITimepoint: 1) Screening, Baseline, Week 4, Week 8, EOT 2) Screening, Baseline, Week 4, Week 8, EOT 3) Screening, Baseline EOT 4) Screening, Baseline EOT 5) Screening, Baseline, EOT 6) Screening, Baseline, EOT 7) Screening, Baseline, EOT | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed