Effectiveness of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual Analogue Score (VAS) Assessment
研究概览
简要总结
Sleep-related leg cramps (SRLCs) are a sleep-related movement disorder whereby painful contractions of the calf or foot muscles arise at sleep onset and during sleep and awaken the patient, interrupting sleep. Application of oral administration with Chinese herbal medicine can enhance the effectiveness and efficacy in treatment of SRLCs.This study will using Shaoyao Gancao Prescription Jiawei by adding Pueraria montana, Salvia Miltiorrhiza, into Shaoyao Gancao. The study aims to evaluate the effectiveness of a Shaoyao Gancao Prescription Jiawei in relieving leg cramps.
详细描述
The study will be conducted in Yan Oi Tong Mrs Shirley W K Siu Medical Centre. All participants diagnosed with sleep-related leg cramp will be screened for eligibility criteria from the general public or referred patients via daily outpatient services. This will be a prospective trial in patients with sleep-related leg cramps (SRLCs). 30 subjects will be recruited from Yan Oi Tong Mrs Shirley W K Siu Medical Centre. The medication will be taken twice daily for 28 consecutive days. Each prescription will consist of 4 herbal granules. Study follow up will be offered every 7 days till 56th day after enrolment. Daily leg cramps log will be filled in by each individual everyday from day 0 to day 56.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complain of muscular spasm and contracture of a limb with difficulty in relaxation and movement during night time, caused by wind-cold dampness chiefly involving the sinews
- •SRLCs occur at least once in the past 7 days or twice in the past 14 days
- •Visual Analogue Scale (VAS) for leg cramp ≥ 5 (0-10) at the last attack
- •Both gender but menopause or sterilization for female subjects
- •Able to fill up the VAS for leg cramp
- •Written informed consent obtained
排除标准
- •Known mental disorder
- •Known serious organic disease including severe coronary function impairment, post-stroke depression and dementia, and auto-immune diseases
- •Known history of renal or liver function impairment;
- •Patients whose blood tests show exclusion criteria
- •Currently taking anticoagulant or antiplatelet
- •Any contraindications for taking herb confirmed by investigator
研究组 & 干预措施
Shaoyao Gancao Decoction Jiawei
Shaoyao Gancao Decoction Jiawei by adding Pueraria montana, Salvia Miltiorrhiza, into Shaoyao Gancao.
The medication will be taken twice daily for 28 consecutive days. Each prescription will consist of 4 herbal granules.
干预措施: Shaoyao Gancao Decoction Jiawei (Drug)
结局指标
主要结局
Visual Analogue Score (VAS) Assessment
时间窗: 4 Weeks
The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.
次要结局
- Short Form 36 Health Survey Questionnaire(8 weeks)
- Visual Analogue Score (VAS) Assessment(8 weeks)
研究者
Prof. Lin Zhixiu
Associate professor
Chinese University of Hong Kong