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

Primary Purpose

Sleep-related Leg Cramps

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Shaoyao Gancao Decoction Jiawei
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep-related Leg Cramps

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shaoyao Gancao Decoction Jiawei

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
August 3, 2020
Last Updated
August 26, 2020
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04500730
Brief Title
Evaluate the Efficacy of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps
Official Title
Effectiveness of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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, 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-related Leg Cramps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shaoyao Gancao Decoction Jiawei
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Shaoyao Gancao Decoction Jiawei
Other Intervention Name(s)
Nong's Concentrated Chinese Medicine Granules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Score (VAS) Assessment
Description
The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Short Form 36 Health Survey Questionnaire
Description
to assess the health-related quality of life of subjects, it ranges from 0-100 scores, the higher the score, the more disability
Time Frame
8 weeks
Title
Visual Analogue Score (VAS) Assessment
Description
The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 -
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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