Phase I : Healthy volunteers Phase II : Dyslipidemia patients Dyslipidemia
Conditions
Interventions
The preparation of Triphala was produced and quality controlled was performed at Phamaceutica Chemistry and Natural Products,
Mahasarakham University,
Thailand.,The Simvastatin(10 mg) was purchased from The Government Pharmaceutical Organization,
prepared and quality controlled was performed at Phamaceutica Chemistry and Natural Products,
Experimental Drug,Active Comparator Drug
Triphala recipes Extract ,Simvastatin
Sponsors
Thai Traditional Medicinal Knowledge Fund
Thammasat university
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: Phase I 1. Male or female 2. Aged 20 – 65 years old 3. Must be healthy 4. No pregnancies and breast-feeding 5. Not participate in other research project 6. No smoking, drug, alcohol and other supplement Phase II 1. Male or female. 2. Aged 20 – 65 years old. 3. Total Cholesterol and LDL-C are above optimal level to borderline high : 200-239 mg/dl or LDL-C 100-159 mg/dl 5. Has been diagnosed with dyslipidemia but has not been prescribed medication by medical doctor. 6. Laboratories results such as AST, ALT,BUN, Creatinine,CBC are normal.
Exclusion criteria
Exclusion criteria: Phase I and II 1. Taking other oral medicine. 2. Medicinal and herbal sensitivities. 3. Having severe illness history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome 1 month Sign, symptom and laboratory result | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcome 3 months Sign, symptom and laboratory result | — |
Countries
Thailand
Contacts
Public ContactPraty Phetkate
Chulabhorn International College of Medicine, Thammasat University
Outcome results
None listed