NCT05980637

Brief Summary

A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine formula in treating Sleep-related Leg Cramps. Subjects will be randomized into a treatment group or placebo group for 4 weeks, and then post-treatment visit at week 6 and week 8.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

August 8, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

July 21, 2023

Last Update Submit

July 31, 2023

Conditions

Sleep-related Leg Cramps

Keywords

Sleep-related Leg CrampsShaoyao Gancao Decoction with Addition

Outcome Measures

Primary Outcomes (1)

  • The change in the Visual Analogue Scale (VAS) of painfulness

    The VAS is a unidimensional measure of pain intensity which will be self assessed by subjects daily, with the scale of 0 (no pain) to 10 (worst imaginable pain).

    week 4

Secondary Outcomes (23)

  • The change in the Visual Analogue Scale (VAS) of painfulness

    week 2

  • The change in the Visual Analogue Scale (VAS) of painfulness

    week 6

  • The change in the Visual Analogue Scale (VAS) of painfulness

    week 8

  • The change in frequency of SRLC

    week 2

  • The change in frequency of SRLC

    week 4

  • +18 more secondary outcomes

Study Arms (2)

Shaoyao Gancao Decoction with Addition

ACTIVE COMPARATOR

11g of Shaoyao Gancao Decoction with Addition granules twice daily for 4 weeks

Drug: Shaoyao Gancao Decoction with Addition

Placebo

PLACEBO COMPARATOR

11g of placebo granules twice daily for 4 weeks

Other: Placebo

Interventions

Shaoyao Gancao Decoction with AdditionDRUG

11g twice daily for 4 weeks

Also known as: SGDA
Shaoyao Gancao Decoction with Addition
PlaceboOTHER

11g twice daily for 4 weeks

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 or above of both genders;
  • Complain of muscular spasm and contracture of the lower limb with difficulty in relaxation and movement at night;
  • Meet the diagnostic criteria of The International Classification of Sleep Disorders (3rd Edition) for SRLC \[2\];
  • Meet the syndrome differentiation of the blood stasis or blood deficiency in Traditional Chinese Medicine.
  • Regular SRLC occurs at least once per week on average within past month;
  • Numeric Pain Rating Scale (NPRS) ≥ 5; and
  • Willing to provide written informed consent.

You may not qualify if:

  • Known mental disorder or neurologic disorder;
  • Known serious organic disease including severe cardiovascular disease, post-stroke depression, cancer and dementia,;
  • Currently on anticoagulants, antiplatelet medications, hypnotics, anxiolytics, positive inotropic drugs, corticosteroids and estrogenic and testosterone which may interfere with the study medications.
  • Impaired hematological profile and liver / renal function exceeds the upper limit of the reference value by 2 times;
  • Known allergic to Chinese medicines; and
  • Any contraindications for taking Chinese medicines in the opinion of the investigators;
  • Known history of lower limb surgery;
  • Known pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Institute of Integrative Medicine

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

shaoyao gancao decoction

Study Officials

  • Zhixiu Lin, PhD

    Hong Kong Institute of Integrative Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiu Lin, PhD

CONTACT

35053476linzx@cuhk.edu.hk

Tin Muk Ho, Master

CONTACT

39433505raytmho@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2023

First Posted

August 8, 2023

Study Start

September 1, 2023

Primary Completion

February 28, 2025

Study Completion

August 31, 2025

Last Updated

August 8, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)