Efficacy and Safety of the HH333 on the Prevention of Ischemic Stroke Recurrence by Small Vessel Disease
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009431
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 236
1) Diagnosed with ischemic stroke due to small vessel disease in the TOAST classification within 90 days of screening based on new neurologic findings + new imaging findings to support them (brain imaging (MR [magnetic resonance] or CT [computed tomography])). Excludes patients within 24 hours of onset or NIHSS Score 21-42, if applicable.
2) Have no communication problems and have voluntarily agreed to participate in the study.
1) Have been diagnosed with a degenerative brain disease (e.g., Parkinson's disease, Alzheimer's disease, etc.)
2) Have a brain condition other than ischemic stroke (e.g., brain tumor, traumatic brain injury, arteriovenous malformation, moyamoya disease, and stroke due to these conditions)
3) Have unstable vital signs at screening (e.g., systolic blood pressure greater than 160 mm Hg despite taking blood pressure medication)
4) Have a serious medical condition (e.g., cirrhosis of the liver, chronic kidney disease stage 5, or severe heart failure (NYHA Class III or greater))
5) Have a history of malignancy, including leukemia and lymphoma, within the past 5 years
6) Patients with hepatic and renal dysfunction
- ALT, AST = 2 times the upper limit of normal at screening
- eGFR < 60 mL/min/1.73 m2 at screening
7) Pregnant, nursing mothers, or women of childbearing potential who have a negative pregnancy test and do not agree to use clinically appropriate contraception* for the duration of the study.
(1) Females of childbearing potential are defined as those who have not experienced menopause (spontaneous amenorrhea for 12 months) since menarche and have not undergone sterilization (bilateral tubal ligation/ectomy, hysterectomy) or menopausal surgery (bilateral oophorectomy).
(2) Male subjects will have a female spouse (or partner) who is also practicing adequate contraception*.
*Adequate contraception is defined as the use of at least one of the following methods
- Hormonal contraception (oral contraceptive pill, injection, patch)
- Implantation of an intrauterine device or intrauterine system
- Sterilization procedures (vasectomy, bilateral salpingectomy/ligation, hysterectomy)
- Complete abstinence: Complete abstinence from sexual intercourse is acceptable if, in the Investigator's judgment, the subject's age, occupation, lifestyle, or sexual orientation warrants contraception. However, periodic abstinence (menstrual cycle method, mucus method, symptomatic temperature method, etc.), abstinence, and extra-vaginal ejaculation are not recognized as adequate contraceptive methods.
8) Previously experienced hypersensitivity after taking HH333's constituent medicines Scutellariae Radix, Coptidis Rhizoma, Phellodendri Cortex, Gardeniae Fructus, and Rhei Rhizoma.
9) Received any other experimental drug within 30 days prior to screening for this study.
(Patients who have not received an experimental drug or who have participated in a simple observational clinical trial are eligible for this study)
10) Difficulty taking the doses required by this study
11) Judged by the investigator as unsuitable for participation in the study for other reasons
12) Plans to use anticoagulants during the study, or has difficulty discontinuing them
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence of ischemic stroke
- Secondary Outcome Measures
Name Time Method Change in Fatigue Severity Scale (FSS) Total Score ;Change in Fatigue Assessment Scale (FAS) Total Score ;Changes in Patient Health Questionnaire (PHQ-9) Total Score;Changes in Probability of each type of Pattern Identification (Fire heat/Dampness-phlegm/Qi deficiency/Yin deficiency);Changes in Korean-National Institutes of Health Stroke Scale (K-NIHSS) Total Score;Changes in Korean modified Rankin Scale (K-mRS) Total Score;Changes in Korean modified Barthel Index (K-MBI) Total Score;Changes in Montreal Cognitive Assessment (MoCA) Total Score;General blood test (Red blood cell, hemoglobin, hematocrit, platelet, white blood cell);General chemistry test (Fasting blood glucose, BUN, creatinine, Na, K, Cl, AST, ALT CRP, calcium, uric acid) ;Urine hCG (Women of childbearing potential only. Excludes sterilization procedures and menopause (if more than 12 months since last menstrual period)), FSH (Early menopause before age 40);Adverse events