Status:
COMPLETED
Evaluate the Efficacy of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Sleep-related Leg Cramps
Eligibility:
All Genders
60-80 years
Phase:
NA
Brief 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, interrupti...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Aged 60-80
- 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
Exclusion
- 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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Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04500730
Start Date
August 1 2019
End Date
December 31 2019
Last Update
August 28 2020
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong