TCTR20201020001
Completed
Phase 1
Phase I clinical trial to evaluate safety, pharmacokinetics and immunomodulatory activity of the capsule formulation of the standardized extract of Atractylodes lancea
ational Research Council of Thailand0 sites48 target enrollmentOctober 20, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- one.
- Sponsor
- ational Research Council of Thailand
- Enrollment
- 48
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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