Evaluate the Efficacy of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

1. Aged 60-80

2. 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

3. SRLCs occur at least once in the past 7 days or twice in the past 14 days

4. Visual Analogue Scale (VAS) for leg cramp ≥ 5 (0-10) at the last attack

5. Both gender but menopause or sterilization for female subjects

6. Able to fill up the VAS for leg cramp

7. Written informed consent obtained

Exclusion Criteria:

1. Known mental disorder 2. Known serious organic disease including severe coronary function impairment, post-stroke depression and dementia, and auto-immune diseases 3. Known history of renal or liver function impairment; 4. Patients whose blood tests show exclusion criteria 5. Currently taking anticoagulant or antiplatelet 6. Any contraindications for taking herb confirmed by investigator

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