Sleep-related Leg CrampsPhase 2/3NCT05980637
Effectiveness and Safety of Shaoyao Gancao Decoction With Addition on the Sleep-related Leg Cramps
A Phase 2/3 study testing Shaoyao Gancao Decoction with Addition in people with Sleep-related Leg Cramps, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sleep-related Leg Cramps
- What is being tested?
- Shaoyao Gancao Decoction with Addition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2023to 31 Aug 2025
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Shaoyao Gancao Decoction With Addition on the Sleep-related Leg Cramps: A Randomized, Double-Blinded, Placebo-Controlled Trial
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.
Read the detailed description
The sleep-related leg cramps (SRLC), also called nocturnal leg cramps (NLC), is a sleep-related limb movement disorder in which painful contractions of the calf or foot muscles occur during sleep, thereby interrupting the patient's rest. It can happen at any ages, but is particularly prevalent among the elderly.
In Chinese medicine, leg cramps, first mentioned in the book of "Huangdi Neijing" (The Yellow Emperor's Cannon of Internal Classic), is characterized by muscular spasm and contracture of a limb resulting in difficulty in relaxation and movement. SRLC is an impediment disease caused by the invasion of wind-cold damp pathogens in the muscles and sinews, together with the dual deficiency of qi and blood that fails to nourish the muscles and sinews, leading to painful contraction of muscles.
Currently, no treatments have been proven both safe and effective for SRLC. Passive stretching and deep tissue massage, which are patient-controlled maneuvers on relieving muscle tension, are usually recommended despite limited proof of effectiveness.
Shaoyao Gancao Decoction was first introduced in the book of "Shang Han Lun" (Treatise on Cold Attack) written by the venerated Physician Zhang Zhongjing in the Eastern Han dynasty. It consists of two herbs, i.e., Paeoniae Radix Alba and Glycyrrhizae Radix et Rhizoma Praeparata Cum Melle, and has the therapeutic functions of moderating painful spasms and alleviating pain. It is commonly used in Chinese medicine practice for treating abdominal pain, lack of strength in walking, spasms of the calf muscles, and restless leg syndrome. Modern pharmacological studies showed that Shaoyao Gancao Decoction possesses anti-inflammatory, analgesic and antispasmodic effects. It has been shown that the use of Shaoyao Gancao Decoction could inhibit mechanical and thermal hyperalgesia in rats with chronic compressive injury.
In 2009, a prospective observational pilot study was conducted to evaluate the effectiveness and safety of modified Shaoyao Gancao Decoction on 30 eligible subjects with SRLC in a cohort study and the result is positive.
Based on the positive results of the pilot study, it shows that SGDA is a promising herbal treatment method for SRLC, and propose a randomized, double-blinded and placebo-controlled trial to scientifically determine the effectiveness and safety of this formula for the treatment of Shaoyao Gancao Decoction with Addition (SGDA) of SRLC. Subjects will be randomized into a treatment group or placebo group for 4 weeks, and then post-treatment visits at week 6 and week 8.
- Conditions
- Sleep-related Leg Cramps
- Being tested
- Shaoyao Gancao Decoction with Addition, Placebo
- Keywords
- Sleep-related Leg Cramps, Shaoyao Gancao Decoction with Addition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shaoyao Gancao Decoction with AdditionDrug
Also called SGDA
11g twice daily for 4 weeks
PlaceboOther
11g twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Shaoyao Gancao Decoction with Addition | Active comparator | 11g of Shaoyao Gancao Decoction with Addition granules twice daily for 4 weeks Receives: Drug: Shaoyao Gancao Decoction with Addition |
| Placebo | Placebo comparator | 11g of placebo granules twice daily for 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: week 4
Secondary outcomes (23)
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).
Measured: week 2
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).
Measured: week 6
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).
Measured: week 8
The change in frequency of SRLC
Frequency of SRLC will be recorded by subjects daily.
Measured: week 2
The change in frequency of SRLC
Frequency of SRLC will be recorded by subjects daily.
Measured: week 4
The change in frequency of SRLC
Frequency of SRLC will be recorded by subjects daily.
Measured: week 6
The change in frequency of SRLC
Frequency of SRLC will be recorded by subjects daily.
Measured: week 8
The change in total duration of SRLC per week
Duration of SRLC will be recorded by subjects daily.
Measured: week 2
The change in total duration of SRLC per week
Duration of SRLC will be recorded by subjects daily.
Measured: week 4
The change in total duration of SRLC per week
Duration of SRLC will be recorded by subjects daily.
Measured: week 6
The change in total duration of SRLC per week
Duration of SRLC will be recorded by subjects daily.
Measured: week 8
The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
The SF-36 is a 36-item scale, which measures eight domains of health status: physical functioning; physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health. It will be self assessed by subjects.
The scores are transformed to range from 0 (where the respondent has the worst possible health) to 100 (where the respondent is in the best possible health).
Measured: week 2
The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
The SF-36 is a 36-item scale, which measures eight domains of health status: physical functioning; physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health. It will be self assessed by subjects.
The scores are transformed to range from 0 (where the respondent has the worst possible health) to 100 (where the respondent is in the best possible health).
Measured: week 4
The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
The SF-36 is a 36-item scale, which measures eight domains of health status: physical functioning; physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health. It will be self assessed by subjects.
The scores are transformed to range from 0 (where the respondent has the worst possible health) to 100 (where the respondent is in the best possible health).
Measured: week 6
The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
The SF-36 is a 36-item scale, which measures eight domains of health status: physical functioning; physical role limitations; bodily pain; general health perceptions; energy/vitality; social functioning; emotional role limitations and mental health. It will be self assessed by subjects.
The scores are transformed to range from 0 (where the respondent has the worst possible health) to 100 (where the respondent is in the best possible health).
Measured: week 8
The change in the Pittsburg Sleep Quality Index (PSQI)
PSQI measures the quality and pattern of sleep in older adult by measuring seven domains in 19 questions, which will be self-assessed by subjects.The scoring is 0-3 on a Likert scale.
Measured: week 2
The change in the Pittsburg Sleep Quality Index (PSQI)
PSQI measures the quality and pattern of sleep in older adult by measuring seven domains in 19 questions, which will be self-assessed by subjects.The scoring is 0-3 on a Likert scale.
Measured: week 4
The change in the Pittsburg Sleep Quality Index (PSQI)
PSQI measures the quality and pattern of sleep in older adult by measuring seven domains in 19 questions, which will be self-assessed by subjects.The scoring is 0-3 on a Likert scale.
Measured: week 6
The change in the Pittsburg Sleep Quality Index (PSQI)
PSQI measures the quality and pattern of sleep in older adult by measuring seven domains in 19 questions, which will be self-assessed by subjects.The scoring is 0-3 on a Likert scale.
Measured: week 8
The score of Patient Global Impression of Change (PGIC)
PGIC is a self-reported measure which reflects a patient's impression on the efficacy of treatment. It is a 7-point scale detecting patient's rating on the overall improvement of treatment. The patient can rate from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Measured: week 2
The score of Patient Global Impression of Change (PGIC)
PGIC is a self-reported measure which reflects a patient's impression on the efficacy of treatment. It is a 7-point scale detecting patient's rating on the overall improvement of treatment. The patient can rate from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Measured: week 4
The score of Patient Global Impression of Change (PGIC)
PGIC is a self-reported measure which reflects a patient's impression on the efficacy of treatment. It is a 7-point scale detecting patient's rating on the overall improvement of treatment. The patient can rate from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Measured: week 6
The score of Patient Global Impression of Change (PGIC)
PGIC is a self-reported measure which reflects a patient's impression on the efficacy of treatment. It is a 7-point scale detecting patient's rating on the overall improvement of treatment. The patient can rate from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- Investigators
- Zhixiu Lin, PhD, Principal investigator, Hong Kong Institute of Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980637
- Sponsor's protocol ID
- Sleep-related Leg Cramps study
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Shaoyao Gancao Decoction With Addition on the Sleep-related Leg Cramps: A Randomized, Double-Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05980637
- Acronym / sponsor ID
- Sleep-related Leg Cramps study
- Conditions
- Sleep-related Leg Cramps
- Keywords
- Sleep-related Leg Cramps, Shaoyao Gancao Decoction with Addition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 8 Aug 2023 (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.
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.
Detailed description
The sleep-related leg cramps (SRLC), also called nocturnal leg cramps (NLC), is a sleep-related limb movement disorder in which painful contractions of the calf or foot muscles occur during sleep, thereby interrupting the patient's rest. It can happen at any ages, but is particularly prevalent among the elderly.
In Chinese medicine, leg cramps, first mentioned in the book of "Huangdi Neijing" (The Yellow Emperor's Cannon of Internal Classic), is characterized by muscular spasm and contracture of a limb resulting in difficulty in relaxation and movement. SRLC is an impediment disease caused by the invasion of wind-cold damp pathogens in the muscles and sinews, together with the dual deficiency of qi and blood that fails to nourish the muscles and sinews, leading to painful contraction of muscles.
Currently, no treatments have been proven both safe and effective for SRLC. Passive stretching and deep tissue massage, which are patient-controlled maneuvers on relieving muscle tension, are usually recommended despite limited proof of effectiveness.
Shaoyao Gancao Decoction was first introduced in the book of "Shang Han Lun" (Treatise on Cold Attack) written by the venerated Physician Zhang Zhongjing in the Eastern Han dynasty. It consists of two herbs, i.e., Paeoniae Radix Alba and Glycyrrhizae Radix et Rhizoma Praeparata Cum Melle, and has the therapeutic functions of moderating painful spasms and alleviating pain. It is commonly used in Chinese medicine practice for treating abdominal pain, lack of strength in walking, spasms of the calf muscles, and restless leg syndrome. Modern pharmacological studies showed that Shaoyao Gancao Decoction possesses anti-inflammatory, analgesic and antispasmodic effects. It has been shown that the use of Shaoyao Gancao Decoction could inhibit mechanical and thermal hyperalgesia in rats with chronic compressive injury.
In 2009, a prospective observational pilot study was conducted to evaluate the effectiveness and safety of modified Shaoyao Gancao Decoction on 30 eligible subjects with SRLC in a cohort study and the result is positive.
Based on the positive results of the pilot study, it shows that SGDA is a promising herbal treatment method for SRLC, and propose a randomized, double-blinded and placebo-controlled trial to scientifically determine the effectiveness and safety of this formula for the treatment of Shaoyao Gancao Decoction with Addition (SGDA) of SRLC. Subjects will be randomized into a treatment group or placebo group for 4 weeks, and then post-treatment visits at week 6 and week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shaoyao Gancao Decoction with Addition | Active comparator | Drug: Shaoyao Gancao Decoction with Addition11g of Shaoyao Gancao Decoction with Addition granules twice daily for 4 weeks |
| Placebo | Placebo comparator | Other: Placebo11g of placebo granules twice daily for 4 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
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 with AdditionAlso: SGDA11g twice daily for 4 weeks | Drug | Shaoyao Gancao Decoction with Addition |
| Placebo11g twice daily for 4 weeks | Other | Placebo |
Primary outcome
The change in the Visual Analogue Scale (VAS) of painfulness
Time frame: week 4
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).
23 secondary outcomes
The change in the Visual Analogue Scale (VAS) of painfulness
Time frame: week 2
The change in the Visual Analogue Scale (VAS) of painfulness
Time frame: week 6
The change in the Visual Analogue Scale (VAS) of painfulness
Time frame: week 8
The change in frequency of SRLC
Time frame: week 2
The change in frequency of SRLC
Time frame: week 4
The change in frequency of SRLC
Time frame: week 6
The change in frequency of SRLC
Time frame: week 8
The change in total duration of SRLC per week
Time frame: week 2
The change in total duration of SRLC per week
Time frame: week 4
The change in total duration of SRLC per week
Time frame: week 6
The change in total duration of SRLC per week
Time frame: week 8
The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
Time frame: week 2
The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
Time frame: week 4
The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
Time frame: week 6
The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
Time frame: week 8
The change in the Pittsburg Sleep Quality Index (PSQI)
Time frame: week 2
The change in the Pittsburg Sleep Quality Index (PSQI)
Time frame: week 4
The change in the Pittsburg Sleep Quality Index (PSQI)
Time frame: week 6
The change in the Pittsburg Sleep Quality Index (PSQI)
Time frame: week 8
The score of Patient Global Impression of Change (PGIC)
Time frame: week 2
The score of Patient Global Impression of Change (PGIC)
Time frame: week 4
The score of Patient Global Impression of Change (PGIC)
Time frame: week 6
The score of Patient Global Impression of Change (PGIC)
Time frame: week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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.
Zhixiu Lin, PhD principal investigator
Hong Kong Institute of Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Shaoyao Gancao Decoction with Addition 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 8 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhixiu Lin, PhD (35053476, linzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the Visual Analogue Scale (VAS) of painfulness (time frame: week 4). 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 8 Aug 2023.