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

NCT04500730 | Completed

• 1 other identifier: SRLC study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep-related Leg Cramps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Short Form 36 Health Survey Questionnaire

  8 weeks

• Visual Analogue Score (VAS) Assessment

  8 weeks

Study Arms (1)

Shaoyao Gancao Decoction Jiawei

EXPERIMENTAL

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

Interventions

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.

Also known as: Nong's Concentrated Chinese Medicine Granules

Shaoyao Gancao Decoction Jiawei

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 5, 2020
• Study Start: August 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

HK (1)