Pharmacokinetics of Gallic Acid Following Single-Dose Administration of Triphala Formulation in Healthy Thai Subjects

Study on the pharmacokinetics of Triphala formulation in healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20180924001

Enrollment

Registered

2018-09-24

Start date

2018-11-09

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers Triphala, gallic acid, ellagic acid, pharmacokinetics

Interventions

&#45

Triphala Formulation&#44

single dose ( 48 hr.) &#45

The standardized Triphala formulation capsules were provided by Pharmaceutical Chemistry and Natural Products&#44

Faculty of Pharmacy&#44

Mahasarakham University,&#45

Triphala formulation&#44

multiple dose ( 7 days) &#45

Mahasarakham University

Experimental Drug,Experimental Drug

Triphala formulation,Triphala formulation

Eligibility

Sex/Gender

All

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: (i) Healthy male or female, aged between 20 and 45 years; (ii) Body mass index 20-25 kg/m2; (iii) No underlying or history of significant clinical conditions/diseases; (iv) No current use of medicines including herbal medicines; (v) Ability to communicate effectively with study personnel; and (vi) Written informed consent obtained

Exclusion criteria

Exclusion criteria: (i) Presence of any acute or chronic diseases or condition which might compromise the hematopoietic, cardiovascular, pulmonary, gastrointestinal, renal, central nervous, endocrine, immunological, dermatological or any other body system; (ii) History of hypersensitivity, allergic conditions (such as asthma, urticaria, eczema) or idiosyncratic reaction to any drugs or herbal products; (iii) History of drug abuse or drug addict or alcoholism (alcohol abuse); (iv) Cigarette smoking and unlikely to refrain from smoking during the study period; (v) Clinically significant abnormal findings from physical examination, laboratory values including chest x-ray during screening; (vi) Suspected or known pregnancy (or positive urine pregnancy test) or breastfeeding; (vii) Participation in another investigational trial

Design outcomes

Primary

Measure	Time frame
Information on the pharmacokinetics of Triphala formulation in healthy subjects 48 hour/person Determination of plasma concentrations of markers in Triphala formulation, Single dose	—

Secondary

Measure	Time frame
Information on the pharmacokinetics of Triphala formulation in healthy subjects 7 days Determination of plasma concentrations of markers in Triphala formulation, multiple dose	—

Countries

Thailand

Contacts

Public ContactPiracha Jumpangern

Chulabhorn International College of Medicine

piracha@tu.ac.th0915529988

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026