ChiCTR2100046632进行中（未招募）早期 1 期
A Randomised Pilot Trial Evaluating a Chinese Medicine Formula in the Treatment of Chronic Subjective Tinnitus
Hong Kong Health and Medical Research Fund1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年9月1日最近更新:
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- feasibility of a full-scale RCT
研究概览
简要总结
To determine the feasibility of performing a full-scale RCT for evaluating the effectiveness and safety of BHT for patients with chronic subjective tinnitus;
To explore whether a TCM formula (BHT) has additional effect on improving the impact of tinnitus in daily life and psychological function and also the perception of tinnitus after 8-week treatment and 4-week follow-up when compared to informative counselling alone.
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 50（—）
- 性别
- All
入选标准
- •Diagnosis of unilateral or bilateral subjective continuous (24 hours) tinnitus with normal hearing or bilateral / unilateral mild to moderate hearing loss. i.e. an average pure-tone audiometry threshold for 500, 1000 and 2000 Hz between 0 dB HL and 55 dB HL;
- •Aged between 18 and 50 years old;
- •Tinnitus duration of at least 6 months;
- •Moderate level of distress caused by tinnitus with scores above 38 on the Chinese (Cantonese) version of the Tinnitus Handicap Inventory (THI-CH) [25-26];
- •Having symptoms of low back pain or general fatigue, and dark or pale tongue, which are symptoms or signs of TCM syndrome of kidney essence deficiency and stagnation of Qi and blood flowing in the meridian.
排除标准
- •Has predisposing disease with tinnitus symptoms amenable to medical or surgical intervention;
- •Has diagnosis of pulsatile tinnitus, somatosounds, or objective tinnitus;
- •Has emotional, psychological, or psychiatric condition precluding full participation of the study;
- •Has ever received any clinical treatment for tinnitus within previous one month;
- •being pregnant, preparing for pregnancy or breast-feeding;
- •has ever taken any Chinese herbal medicine treatment in the previous one month;
- •has history of being allergy to Chinese herbal medicines;
- •Has ever taken any anti-coagulant or anti-platelet agents other than low dose (≤81 mg per day) aspirin;
- •Has sever diabetes, hypertension or cardiac, liver, renal, cerebrovascular disease, or malignant diseases.
研究组 & 干预措施
Experimental group
Chinese medicine formula plus informative counselling
Control group
Informative counselling
结局指标
主要结局
feasibility of a full-scale RCT
次要结局
未报告次要终点
研究者
研究点 (1)
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