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

NCT ID: NCT04500730

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep-related Leg Cramps

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Shaoyao Gancao Decoction Jiawei

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Nong's Concentrated Chinese Medicine Granules

Eligibility Criteria

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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

\-
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Prof. Lin Zhixiu

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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SRLC study

Identifier Type: -

Identifier Source: org_study_id

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