Study on Safety and Efficacy of Triphala recipes extract in normal volunteers and dyslipidemia patients

Phase 1

Recruiting

• Conditions: Phase I : Healthy volunteersPhase II : Dyslipidemia patients; Dyslipidemia

• Registration Number: TCTR20180423002
• Lead Sponsor: Thai Traditional Medicinal Knowledge Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-23
• Study Completion: 2018-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 76

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

Phase I and II
1. Taking other oral medicine.
2. Medicinal and herbal sensitivities.
3. Having severe illness history

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety outcome 1 month Sign, symptom and laboratory result

Secondary Outcome Measures

Name	Time	Method
Efficacy outcome 3 months Sign, symptom and laboratory result