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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT04500730

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep-related Leg Cramps	Drug: Shaoyao Gancao Decoction Jiawei	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual Analogue Score (VAS) Assessment [4 Weeks]
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 [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 [8 weeks]
The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Chinese University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Lin Zhixiu, Associate professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT04500730

Other Study ID Numbers:

SRLC study

First Posted:

Aug 5, 2020

Last Update Posted:

Aug 28, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscle Cramp

Study Results

No Results Posted as of Aug 28, 2020