Healthy middle-aged and elderly volunteers middle age, elderly
Conditions
Interventions
On days 0-2, the participants will take Triphala (500 mg/capsule containing 404 mg of herbal powder) 2 capsules four times a day before meal and bedtime (total dose 3,232 mg/day). If the participants
Experimental Drug,Placebo Comparator No treatment
Triphala,Placebo
Sponsors
Faculty of Medicine, Chiang Mai University
Eligibility
Sex/Gender
All
Age
51 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged between 51 to 70 years; 2. No serious/uncontrolled underlying disease; 3. BMI 18.5-29.9 kg/m2; 4. Able to read and write in Thai; and 5) All participants will be informed both verbally and in writing of the possible risks and adverse events which may occur during the study and must sign the written consent forms to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Physical examination revealed clinically significant abnormalities Temperature more than 37.5 c Pulse more than 100 beats/min Breathing more than 24 breaths/min Blood pressure less than 90/60 or more than 140/90 mm Hg 2. Receiving any vaccination within the past 3 months 3. Receiving any immunosuppressants such as corticosteroids, cyclosporin, tacrolimus, methotrexate, or monoclonal antibodies within the last 3 months 4. Receiving any herbal medication within the last 1 week 5. Having any infection within the last 2 weeks 6. Having a history of diarrhea-predominant irritable bowel syndrome (IBS) or alternating constipation and diarrhea IBS 7. Having a history of autoimmune diseases 8. Have a history of diabetes mellitus 9. Having a history of hepatic or renal disease 10. Having a history of uncontrolled hypertension and/or uncontrolled hyperlipidemia 11. Having a history of cardiovascular disease or thrombosis 12. Receiving antiplatelet drugs (such as clopidogrel or aspirin) or anticoagulants such as warfarin 13. Having a history of cancer 14. Having a history of severe allergic to herbal medicine/product 15. Smoking 16. Alcohol consumption more than 2 glasses per day 17. Pregnant, lactating or 18. Clinically significant abnormalities in blood chemistry and hematology Hemoglobin less than10 g/dL White blood cells less than 4,000 per cu. mm. Platelets less than 100,000 per cu. mm. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 1.5 times the upper limit of normal Estimate glomerular filtration rate (eGFR) less than 60 mL per min per 1.73 m2 calculated by an equation developed by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Abnormal urine analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune cells Day 0, 3, 7, 14, and 28 Flow cytometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokines Day 0, 3, 7, 14, and 28 ELISA,Number of white blood cells Day 0, 3, 7, 14, and 28 CBC,Blood glucose level Day 0 and 28 Fasting blood sugar,Lipid profile Day 0 and 28 Total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride ,Quality of life Day 0, 7, 14, and 28 EQ 5D 5L questionnaire ,Safety Day 0, 14, and 28 BUN, Cr, ALT, and AST | — |
Countries
Thailand
Contacts
Public ContactNutthiya Hanprasertpong
Department of Pharmacology, Faculty of Medicine, Chiang Mai University
Outcome results
None listed