Safety evaluation and effect of consumption of health product containing the combined extract of Khao Kum and Dill on the alterations of clinical symptoms and ischemic stroke biomarkers in transient ischemic attack and ischemic stroke patients
Phase 1
- Conditions
- transient ischemic attackIschemic strokeBrain SupplementKhao KumDilltransient ischemic attackIschemic stroke
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1.Acute ischaemic stroke within the past 5-10 days that caused hemiparesis or hemiplegia
2.Aged between 18 years and 85 years
3.Fugl-Meyer motor scale (FMMS) scores of 55 or less at baseline
Exclusion Criteria
1.Post rt-PA
2.Severe post-stroke disability (NIHSS score >20)
3.Previous stroke with motor deficit, comprehension deficits (aphasia)
Previous depression or MADRS score of more than 19; taking antidepressant drugs, monoamine oxidase inhibitors, neuroleptic drugs, or benzodiazepines during the month before inclusion
4.Undergoing carotid endarterectomy
5.Pregnancy
6.Major diseases that would prevent follow-up. Enrolment, follow-up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes of hematological and clinical chemistry parameters 6 weeks laboratory
- Secondary Outcome Measures
Name Time Method Vascular cell adhesion molecule1(VCAM-1) 6 weeks ELISA Kit ,Matrix metalloproteinases 9 (MMP-9) 6 weeks ELISA Kit ,VonWillebrand Factor (VWF) 6 weeks ELISA Kit ,S100β 6 weeks ELISA Kit ,safety evaluation and side effect 6 weeks Questionair,electrocardiogram 6 weeks electrocardiography equipment,NIHSS score 6 weeks Questionair,Stool examination (PH, Lactobacillus spp., Bifidobacterium spp. and Short chain fatty acid) 6 weeks laboratory