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

Effectiveness of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps - A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep-related Leg Cramps
• Intervention / Treatment: Drug: Shaoyao Gancao Decoction Jiawei

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Shaoyao Gancao Decoction Jiawei; Study herb will be prescribed for 28 consecutive days. 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.; Other Names: Nong's Concentrated Chinese Medicine Granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Score (VAS) Assessment	The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.	4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form 36 Health Survey Questionnaire	to assess the health-related quality of life of subjects, it ranges from 0-100 scores, the higher the score, the more disability	8 weeks
Visual Analogue Score (VAS) Assessment	The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.	8 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (ACTUAL): August 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Cramp
• Other Study ID Numbers: SRLC study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No