A Phase 2/3 interventional study of Shaoyao Gancao Decoction with Addition and Placebo in Sleep-related Leg Cramps, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by Chinese University of Hong Kong · Phase 2/3, Interventional, and Treatment
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.
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.
65 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 59 interventional studies indexed under Muscle Cramp.
Browse Muscle Cramp studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
11g of Shaoyao Gancao Decoction with Addition granules twice daily for 4 weeks
Drug: Shaoyao Gancao Decoction with Addition
11g of placebo granules twice daily for 4 weeks
Other: Placebo
11g twice daily for 4 weeks
Also known as: SGDA
11g twice daily for 4 weeks
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).
Time frame: week 4
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).
Time frame: 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).
Time frame: 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).
Time frame: week 8
The change in frequency of SRLC
Frequency of SRLC will be recorded by subjects daily.
Time frame: week 2
The change in frequency of SRLC
Frequency of SRLC will be recorded by subjects daily.
Time frame: week 4
The change in frequency of SRLC
Frequency of SRLC will be recorded by subjects daily.
Time frame: week 6
The change in frequency of SRLC
Frequency of SRLC will be recorded by subjects daily.
Time frame: week 8
The change in total duration of SRLC per week
Duration of SRLC will be recorded by subjects daily.
Time frame: week 2
The change in total duration of SRLC per week
Duration of SRLC will be recorded by subjects daily.
Time frame: week 4
The change in total duration of SRLC per week
Duration of SRLC will be recorded by subjects daily.
Time frame: week 6
The change in total duration of SRLC per week
Duration of SRLC will be recorded by subjects daily.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: week 8
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2023; primary completion for Feb 2025, 17 months later.
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This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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