Study the effects of Andrographis paniculata on platelet aggregation in Thai healthy volunteers: the pilot study

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20141128001
• Date of registration: 28/11/2014
• Prospective Registration: No
• Primary sponsor: Faculty of Medicine Siriraj Hospital
• Public title: Study the effects of Andrographis paniculata on platelet aggregation in Thai healthy volunteers: the pilot study
• Scientific title: Study the effects of Andrographis paniculata on platelet aggregation in Thai healthy volunteers: the pilot study
• Date of first enrolment: 25/04/2014
• Recruitment status: Completed
• URL: https://www.thaiclinicaltrials.org/show/TCTR20141128001
• Study type: Interventional
• Study design: Non-randomized
• Phase: Phase 1

Countries of recruitment

Thailand

Contacts

• Name: Assoc. Prof. Pravit Akarasereenont
• Affiliation: Faculty of Medicine Siriraj Hospital

• Name: Assoc. Prof. Pravit Akarasereenont
• Affiliation: Faculty of Medicine Siriraj Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female age between 25-60 years
2. Body mass index (BMI) between 18 to 24 kg/m^2
3. Who has been determined healthy physical examination, medical history, and vital signs
4. Female, non pregnant or use the contraceptive or not currently breast feeding and have negative pregnancy test
5. Who be willing to participate and signed the informed consent form

Exclusion criteria: 1. Who has history usage of other drugs, especially which can effect platelet aggregation
2. Who has history of allergic reactions or allergy to NSAIDs, Andrographis paniculata or its derivative compounds
3. Who is no smoke and alcohol
4. Who has donated blood within last 90 days before participate

Age minimum: 25 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

healthy human volunteers

Intervention(s)

All healthy volunteers was fasting for 12 hour before received 2 g of Andrographis paniculata capsules for 3 times in 4 hour intervals. Compared the effects of Andrographis paniculata before and after 2 and 24 hour administration.

Active Comparator Drug

Andrographis paniculata

Primary Outcome(s)

A. paniculata has the effect on platelet aggregation in human platelet 0, 2, and 24 hour after A. paniculata administration aggregation assay

Secondary Outcome(s)

A. paniculata has the effect on COX activity and P-selectin in human platelet aggregation 0, 2, and 24 hour after A. paniculata administration RT-PCR, Western blot and ELISA

Source(s) of Monetary Support

Faculty of Medicine Siriraj Hospital

Secondary Sponsor(s)

Faculty of Medicine Siriraj Hospital

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Siriraj Institutional Review Board

Results

• Date Completed: 28/05/2014