Phase I clinical trial to evaluate safety, pharmacokinetics and immunomodulatory activity of the capsule formulation of the standardized extract of Atractylodes lancea

Phase 1

Completed

• Conditions: Atractylodes lancea; Phase I clinical trial; one.; Pharmacokinetics; Safety; Immunomodulatory activity

• Registration Number: TCTR20201020001
• Lead Sponsor: ational Research Council of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-06-10
• Study Start: 2020-10-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

non-smokers and non-alcohol drinkers and were residents of Bangkok or suburb areas were recruited into the study. Additional inclusion criteria were (i) absence of acute or chronic diseases that could affect vital organ functions, (ii) no history of surgery within the past six months, (ii) no history of hypersensitivity reactions or idiosyncratic reactions to drugs or herbal products, (iv) no concurrent or history of administration of drugs or herbal products within the past two weeks (except antipyretic or anti-emetic drugs), (v) no history or current drug abuse, (vi) ability to communicate (reading, writing, and speaking) effectively, and (vii) willing to give informed consent for study participation.

Exclusion Criteria

with (i) clinical significant abnormality of physical examination, (ii) clinical significant abnormality of electrocardiograms (ECG) or chest x-ray, (iii) pregnancy or lactation, (iv) blood tests positive for HBsAg, HCV, or HIV, (v) abnormality in blood coagulation or history or concurrent use of anticoagulants or antiplatelets, or (vi) participation in any other study in the past three months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events baseline, and daily until day 23 NIH/NCI Common Toxicity Criteria (CTC) Grading System for Adverse Events,Serum cytokine levels baseline, days 1, 2, 3, 7, and 14 ELISA assay,Safety 10 to NIH/NCI Common Toxicity Criteria (CTC) Grading System for Adverse Events

Secondary Outcome Measures

Name	Time	Method
Immunomodulatory activity baseline and on days 1, 2, 3, 7 and 14 of dosing cytokine levels, immune cells,pharamcokinetic parameters baseline, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 hours of dosin non-compartment and compartment analysis