KCT0009431招募中Unknown
Clinical Efficacy and Safety of the Herbal Prescription, HH333 in Preventing Recurrent Stroke in Patients With Ischemic Stroke induced by Small Vessel Disease: A Double-blind, Randomized, Multicenter, Prospective, Pilot Investigator Clinical Trial
Kyung Hee University Oriental Medical Center0 个研究点目标入组 236 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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