None. Atractylodes lancea Pharmacokinetics Phase I clinical trial Safety Immunomodulatory activity
Conditions
Interventions
,multiple oral doses of either 1,
000 mg of capsule formulation of the standardized AL extract or placebo daily for 21 days at the ratio of 20:4 participants.
,a single oral dose of either 1,
000 mg of capsule formulation of the standardized AL extract (9 capsules,
112.5 mg each,
Kaolaor Laboratories Co. Ltd.) or placebo at the ratio of 20:4 participants.
,Placebo Comparator Drug,Placebo Comparator Drug
,Multiple doses AL,Single dose AL
Sponsors
National Research Council of Thailand
Thammasat University
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
tHAILAND
Contacts
Public ContactKesara Na-Bangchang
Thammasat University
Outcome results
None listed