Safety evaluation and effect of consumption of Mulberry Capsule on the alterations of clinical symptoms and ischemic stroke biomarkers in transient ischemic attack and ischemic stroke patients
Phase 1
Recruiting
- Conditions
- transient ischemic attackIschemic strokeBrain SupplementMulberrytransient ischemic attackIschemic stroke
- Registration Number
- TCTR20201222006
- Lead Sponsor
- Health Systems Research Institute, Thailand (HSRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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 70 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)
4. Previous depression or MADRS score of more than 19; taking antidepressant drugs, monoamine oxidase inhibitors, neuroleptic drugs, or benzodiazepines during the month before inclusion
5. Undergoing carotid endarterectomy
6. Pregnancy
7. 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