Status:
UNKNOWN
Effectiveness and Safety of Shaoyao Gancao Decoction With Addition on the Sleep-related Leg Cramps
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Sleep-related Leg Cramps
Eligibility:
All Genders
60+ years
Phase:
PHASE2
PHASE3
Brief Summary
A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine formula in treating Sleep-related Leg Cramps. Subjects will be randomized into a treatment group or placebo gro...
Detailed Description
The sleep-related leg cramps (SRLC), also called nocturnal leg cramps (NLC), is a sleep-related limb movement disorder in which painful contractions of the calf or foot muscles occur during sleep, the...
Eligibility Criteria
Inclusion
- Aged 60 or above of both genders;
- Complain of muscular spasm and contracture of the lower limb with difficulty in relaxation and movement at night;
- Meet the diagnostic criteria of The International Classification of Sleep Disorders (3rd Edition) for SRLC \[2\];
- Meet the syndrome differentiation of the blood stasis or blood deficiency in Traditional Chinese Medicine.
- Regular SRLC occurs at least once per week on average within past month;
- Numeric Pain Rating Scale (NPRS) ≥ 5; and
- Willing to provide written informed consent.
Exclusion
- Known mental disorder or neurologic disorder;
- Known serious organic disease including severe cardiovascular disease, post-stroke depression, cancer and dementia,;
- Currently on anticoagulants, antiplatelet medications, hypnotics, anxiolytics, positive inotropic drugs, corticosteroids and estrogenic and testosterone which may interfere with the study medications.
- Impaired hematological profile and liver / renal function exceeds the upper limit of the reference value by 2 times;
- Known allergic to Chinese medicines; and
- Any contraindications for taking Chinese medicines in the opinion of the investigators;
- Known history of lower limb surgery;
- Known pregnant or breast-feeding.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05980637
Start Date
September 1 2023
End Date
August 31 2025
Last Update
August 8 2023
Active Locations (1)
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1
Hong Kong Institute of Integrative Medicine
Hong Kong, Hong Kong