Sleep-related Leg CrampsNCT04500730
Evaluate the Efficacy of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps
A study testing Shaoyao Gancao Decoction Jiawei in people with Sleep-related Leg Cramps, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Sleep-related Leg Cramps
- What is being tested?
- Shaoyao Gancao Decoction Jiawei
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps - A Pilot Study
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.
Read the 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.
- Conditions
- Sleep-related Leg Cramps
- Being tested
- Shaoyao Gancao Decoction Jiawei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shaoyao Gancao Decoction JiaweiDrug
Also called Nong's Concentrated Chinese Medicine Granules
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Shaoyao Gancao Decoction Jiawei |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Weeks
Secondary outcomes (2)
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
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Aug 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-related Leg CrampsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500730
- Sponsor's protocol ID
- SRLC study
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps - A Pilot Study
- ClinicalTrials.gov ID
- NCT04500730
- Acronym / sponsor ID
- SRLC study
- Conditions
- Sleep-related Leg Cramps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shaoyao Gancao Decoction Jiawei | Experimental | Drug: Shaoyao Gancao Decoction JiaweiShaoyao 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shaoyao Gancao Decoction JiaweiAlso: Nong's Concentrated Chinese Medicine GranulesStudy 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. | Drug | Shaoyao Gancao Decoction Jiawei |
Primary outcome
Visual Analogue Score (VAS) Assessment
Time frame: 4 Weeks
The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.
2 secondary outcomes
Short Form 36 Health Survey Questionnaire
Time frame: 8 weeks
Visual Analogue Score (VAS) Assessment
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
Related trials for Sleep-related Leg Cramps
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shaoyao Gancao Decoction Jiawei in people with Sleep-related Leg Cramps, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (VAS) Assessment (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.