The study of plasma and serum metabolite profile after administration of Thai Herbal Suksaiyad Formula (SSF) in relation to platelet aggregation in individual healthy volunteer

R2R unit Siriraj hospital0 sites30 target enrollmentApril 5, 2021

Conditionspreliminary safety study metabolite profile Thai Herbal Suksaiyad Formula platelet aggregation

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: preliminary safety study
Sponsor: R2R unit Siriraj hospital
Enrollment: 30
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 5, 2021

End Date

July 30, 2021

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

R2R unit Siriraj hospital

Eligibility Criteria

Inclusion Criteria

•1\. Male or Female, aged 18\-45 years.
•2\. BMI or Body Mass Index (BMI) between 18\.00\-29\.00 kg / square meter.
•3\. Good health through vital signs measurement and physical examination or no clinically significant abnormal symptoms according to the opinion of the researcher.
•4\. Volunteers must refrain from herbs, drugs made from various herbs and dietary supplements within 14 days prior to participation in the program on the date of blood sample collection and agree to continue to refrain until the end of blood sample collection.
•5\. Volunteers are required to abstain from other drugs at least 14 days prior to participation on the date of blood sample collection and agree to continue to abstain until the end of blood sample collection, including the safety follow\-up period.
•6\. Volunteers are required to refrain from caffeine\-containing beverages. And alcohol\-containing beverages at least 72 hours prior to participation on the date of blood sample collection and agree to continue to refrain until the end of blood sample collection.
•7\.Clinical chemistry laboratory diagnostic results are Complete Blood Count (CBC), Blood Urea Nitrogen, Creatinine, Fasting Blood Sugar (FBS), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglyceride. , Aspartate transaminase, Alanine transaminase in the normal range or not clinically significant according to the clinician's opinion.
•8\. Volunteers can understand the requirements. In the research project and agree to sign and date on the document of intent of consent to participate in the research project, which has been approved by the ethics committee before joining the selection to the project or before proceeding with the procedures in a research project.

Exclusion Criteria

•1\.People who are being treated with drugs that affect platelet function such as aspirin, clopidogrel, ticlopidine etc.
•2\. People with a history of psychiatric disorders such as psychosis, concurrent active mood disorder or anxiety disorder.
•3\. Have a history of major bleeding disorders within the past 6 months, such as an accident or surgery Including illnesses that require blood transfusions
•4\. Have a history of allergic to herbal medicine or ingredients of herbs in SSF at least 1 type, namely camphor, neem leaves, Sahashkhunthet, Somul Waeng, Thien Dam, koson, sandalwood, bunnag flower, pepper, ginger, Dipli and Marijuana leaf
•5\. Have a history of illness related to impaired renal and liver function or have the results of clinical chemistry laboratory tests of liver function excessively.
•6\.A person who donated blood or lost blood in the following amounts
•greater than or equal to 50 milliliters to 499 milliliters within the 30 day period prior to participation, or greater than or equal to 500 ml within 56 days prior to participation
•7\. Participate in other studies in the 14 days prior to the start of the study.
•8\. Pregnant female volunteers are in the process of breastfeeding, taking birth control pills, during menstruation or have a pregnancy hormone test positive pregnancy