Completed

NCT Number: NCT04500730

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

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.

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Key information

Conditions

Sleep-related Leg Cramps

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Shaoyao Gancao Decoction Jiawei

Drug

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

Primary outcomes

Visual Analogue Score (VAS) Assessment

Time frame: 4 Weeks

The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.

Secondary outcomes

Short Form 36 Health Survey Questionnaire

Time frame: 8 weeks

to assess the health-related quality of life of subjects, it ranges from 0-100 scores, the higher the score, the more disability
Visual Analogue Score (VAS) Assessment

Time frame: 8 weeks

The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Aug 5, 2020
Registry last updated: Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.