The herb-drug interaction in ischemic stroke patients

The herb-drug interaction between O-Geok-San, Bojungikqitang and aspirin in ischemic stroke patients: randomized placebo controlled clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002049

Enrollment

Registered

2016-09-09

Start date

2011-09-19

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Eligible ischemic stroke patients were randomly allocated to either OJS treatment or placebo, in addition to aspirin. After allocation, each subject randomly received oral administration of OJS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Subjects between 40 and 80 years of age (2) Subjects taking aspirin for over 3 months with a previous diagnosis of ischemic stroke

Exclusion criteria

Exclusion criteria: (1) Subjects with known allergy to aspirin (2) Subjects with aspartate transaminase (AST) or alanine transaminase (ALT) >2 × the upper limit of normal (ULN) at screening, and serum creatinine concentration >2 times the ULN at screening. (3) Heavy smoking, alcoholic subjects (4) Subjects who have a known history of GI tract surgery (5) Subjects who took Barbiturates or metabolic enzyme-related drugs within 30 days before study (6) Subjects who took any medication that can influence O-Geok-San, Bojungikqitang and aspirin whithin 10 days before study (7) Subjects who have a plan to take acupuncture treatment

Design outcomes

Primary

Measure	Time frame
Platelet aggregation	—

Secondary

Measure	Time frame
plasma concentraion of acetyl salicylic acid, salicylic acid and ;plasma concentraion of thromboxane B2 level	—

Countries

Korea, Republic of

Contacts

Public ContactByung-Cheol Lee

Kyung Hee University Oriental Medical Center

hydrolee99@hanmail.net

Outcome results