xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05980637</url>
    </required_header>
    <id_info>
      <org_study_id>Sleep-related Leg Cramps study</org_study_id>
      <nct_id>NCT05980637</nct_id>
    </id_info>
    <brief_title>Effectiveness and Safety of Shaoyao Gancao Decoction With Addition on the Sleep-related Leg Cramps</brief_title>
    <official_title>Effectiveness and Safety of Shaoyao Gancao Decoction With Addition on the Sleep-related Leg Cramps: A Randomized, Double-Blinded, Placebo-Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese University of Hong Kong</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine&#xD;
        formula in treating Sleep-related Leg Cramps. Subjects will be randomized into a treatment&#xD;
        group or placebo group for 4 weeks, and then post-treatment visit at week 6 and week 8.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The sleep-related leg cramps (SRLC), also called nocturnal leg cramps (NLC), is a&#xD;
        sleep-related limb movement disorder in which painful contractions of the calf or foot&#xD;
        muscles occur during sleep, thereby interrupting the patient's rest. It can happen at any&#xD;
        ages, but is particularly prevalent among the elderly.&#xD;
  &#xD;
        In Chinese medicine, leg cramps, first mentioned in the book of &quot;Huangdi Neijing&quot; (The Yellow&#xD;
        Emperor's Cannon of Internal Classic), is characterized by muscular spasm and contracture of&#xD;
        a limb resulting in difficulty in relaxation and movement. SRLC is an impediment disease&#xD;
        caused by the invasion of wind-cold damp pathogens in the muscles and sinews, together with&#xD;
        the dual deficiency of qi and blood that fails to nourish the muscles and sinews, leading to&#xD;
        painful contraction of muscles.&#xD;
  &#xD;
        Currently, no treatments have been proven both safe and effective for SRLC. Passive&#xD;
        stretching and deep tissue massage, which are patient-controlled maneuvers on relieving&#xD;
        muscle tension, are usually recommended despite limited proof of effectiveness.&#xD;
  &#xD;
        Shaoyao Gancao Decoction was first introduced in the book of &quot;Shang Han Lun&quot; (Treatise on&#xD;
        Cold Attack) written by the venerated Physician Zhang Zhongjing in the Eastern Han dynasty.&#xD;
        It consists of two herbs, i.e., Paeoniae Radix Alba and Glycyrrhizae Radix et Rhizoma&#xD;
        Praeparata Cum Melle, and has the therapeutic functions of moderating painful spasms and&#xD;
        alleviating pain. It is commonly used in Chinese medicine practice for treating abdominal&#xD;
        pain, lack of strength in walking, spasms of the calf muscles, and restless leg syndrome.&#xD;
        Modern pharmacological studies showed that Shaoyao Gancao Decoction possesses&#xD;
        anti-inflammatory, analgesic and antispasmodic effects. It has been shown that the use of&#xD;
        Shaoyao Gancao Decoction could inhibit mechanical and thermal hyperalgesia in rats with&#xD;
        chronic compressive injury.&#xD;
  &#xD;
        In 2009, a prospective observational pilot study was conducted to evaluate the effectiveness&#xD;
        and safety of modified Shaoyao Gancao Decoction on 30 eligible subjects with SRLC in a cohort&#xD;
        study and the result is positive.&#xD;
  &#xD;
        Based on the positive results of the pilot study, it shows that SGDA is a promising herbal&#xD;
        treatment method for SRLC, and propose a randomized, double-blinded and placebo-controlled&#xD;
        trial to scientifically determine the effectiveness and safety of this formula for the&#xD;
        treatment of Shaoyao Gancao Decoction with Addition (SGDA) of SRLC. Subjects will be&#xD;
        randomized into a treatment group or placebo group for 4 weeks, and then post-treatment&#xD;
        visits at week 6 and week 8.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2025</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The change in the Visual Analogue Scale (VAS) of painfulness</measure>
      <time_frame>week 4</time_frame>
      <description>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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The change in the Visual Analogue Scale (VAS) of painfulness</measure>
      <time_frame>week 2</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Visual Analogue Scale (VAS) of painfulness</measure>
      <time_frame>week 6</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Visual Analogue Scale (VAS) of painfulness</measure>
      <time_frame>week 8</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in frequency of SRLC</measure>
      <time_frame>week 2</time_frame>
      <description>Frequency of SRLC will be recorded by subjects daily.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in frequency of SRLC</measure>
      <time_frame>week 4</time_frame>
      <description>Frequency of SRLC will be recorded by subjects daily.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in frequency of SRLC</measure>
      <time_frame>week 6</time_frame>
      <description>Frequency of SRLC will be recorded by subjects daily.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in frequency of SRLC</measure>
      <time_frame>week 8</time_frame>
      <description>Frequency of SRLC will be recorded by subjects daily.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in total duration of SRLC per week</measure>
      <time_frame>week 2</time_frame>
      <description>Duration of SRLC will be recorded by subjects daily.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in total duration of SRLC per week</measure>
      <time_frame>week 4</time_frame>
      <description>Duration of SRLC will be recorded by subjects daily.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in total duration of SRLC per week</measure>
      <time_frame>week 6</time_frame>
      <description>Duration of SRLC will be recorded by subjects daily.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in total duration of SRLC per week</measure>
      <time_frame>week 8</time_frame>
      <description>Duration of SRLC will be recorded by subjects daily.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Short Form 36 Health Survey Questionnaire (SF-36) score</measure>
      <time_frame>week 2</time_frame>
      <description>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.&#xD;
  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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Short Form 36 Health Survey Questionnaire (SF-36) score</measure>
      <time_frame>week 4</time_frame>
      <description>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.&#xD;
  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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Short Form 36 Health Survey Questionnaire (SF-36) score</measure>
      <time_frame>week 6</time_frame>
      <description>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.&#xD;
  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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Short Form 36 Health Survey Questionnaire (SF-36) score</measure>
      <time_frame>week 8</time_frame>
      <description>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.&#xD;
  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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Pittsburg Sleep Quality Index (PSQI)</measure>
      <time_frame>week 2</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Pittsburg Sleep Quality Index (PSQI)</measure>
      <time_frame>week 4</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Pittsburg Sleep Quality Index (PSQI)</measure>
      <time_frame>week 6</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change in the Pittsburg Sleep Quality Index (PSQI)</measure>
      <time_frame>week 8</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The score of Patient Global Impression of Change (PGIC)</measure>
      <time_frame>week 2</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The score of Patient Global Impression of Change (PGIC)</measure>
      <time_frame>week 4</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The score of Patient Global Impression of Change (PGIC)</measure>
      <time_frame>week 6</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The score of Patient Global Impression of Change (PGIC)</measure>
      <time_frame>week 8</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Sleep-related Leg Cramps</condition>
    <arm_group>
      <arm_group_label>Shaoyao Gancao Decoction with Addition</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>11g of Shaoyao Gancao Decoction with Addition granules twice daily for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>11g of placebo granules twice daily for 4 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Shaoyao Gancao Decoction with Addition</intervention_name>
      <description>11g twice daily for 4 weeks</description>
      <arm_group_label>Shaoyao Gancao Decoction with Addition</arm_group_label>
      <other_name>SGDA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>11g twice daily for 4 weeks</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 60 or above of both genders;&#xD;
  &#xD;
            -  Complain of muscular spasm and contracture of the lower limb with difficulty in&#xD;
               relaxation and movement at night;&#xD;
  &#xD;
            -  Meet the diagnostic criteria of The International Classification of Sleep Disorders&#xD;
               (3rd Edition) for SRLC [2];&#xD;
  &#xD;
            -  Meet the syndrome differentiation of the blood stasis or blood deficiency in&#xD;
               Traditional Chinese Medicine.&#xD;
  &#xD;
            -  Regular SRLC occurs at least once per week on average within past month;&#xD;
  &#xD;
            -  Numeric Pain Rating Scale (NPRS) ≥ 5; and&#xD;
  &#xD;
            -  Willing to provide written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known mental disorder or neurologic disorder;&#xD;
  &#xD;
            -  Known serious organic disease including severe cardiovascular disease, post-stroke&#xD;
               depression, cancer and dementia,;&#xD;
  &#xD;
            -  Currently on anticoagulants, antiplatelet medications, hypnotics, anxiolytics,&#xD;
               positive inotropic drugs, corticosteroids and estrogenic and testosterone which may&#xD;
               interfere with the study medications.&#xD;
  &#xD;
            -  Impaired hematological profile and liver / renal function exceeds the upper limit of&#xD;
               the reference value by 2 times;&#xD;
  &#xD;
            -  Known allergic to Chinese medicines; and&#xD;
  &#xD;
            -  Any contraindications for taking Chinese medicines in the opinion of the&#xD;
               investigators;&#xD;
  &#xD;
            -  Known history of lower limb surgery;&#xD;
  &#xD;
            -  Known pregnant or breast-feeding.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhixiu Lin, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hong Kong Institute of Integrative Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhixiu Lin, PhD</last_name>
      <phone>35053476</phone>
      <email>linzx@cuhk.edu.hk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tin Muk Ho, Master</last_name>
      <phone>39433505</phone>
      <email>raytmho@cuhk.edu.hk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hong Kong Institute of Integrative Medicine</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Prof. Lin Zhixiu</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Sleep-related Leg Cramps</keyword>
    <keyword>Shaoyao Gancao Decoction with Addition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscle Cramp</mesh_term>
      <mesh_term>Spasm</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05980637
  org study id: Sleep-related Leg Cramps study
  nct id: NCT05980637
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: The change in the Visual Analogue Scale (VAS) of painfulness
  time frame: week 4
  description: 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).
  measure: The change in the Visual Analogue Scale (VAS) of painfulness
  time frame: week 2
  description: 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).
  measure: The change in the Visual Analogue Scale (VAS) of painfulness
  time frame: week 6
  description: 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).
  measure: The change in the Visual Analogue Scale (VAS) of painfulness
  time frame: week 8
  description: 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).
  measure: The change in frequency of SRLC
  time frame: week 2
  description: Frequency of SRLC will be recorded by subjects daily.
  measure: The change in frequency of SRLC
  time frame: week 4
  description: Frequency of SRLC will be recorded by subjects daily.
  measure: The change in frequency of SRLC
  time frame: week 6
  description: Frequency of SRLC will be recorded by subjects daily.
  measure: The change in frequency of SRLC
  time frame: week 8
  description: Frequency of SRLC will be recorded by subjects daily.
  measure: The change in total duration of SRLC per week
  time frame: week 2
  description: Duration of SRLC will be recorded by subjects daily.
  measure: The change in total duration of SRLC per week
  time frame: week 4
  description: Duration of SRLC will be recorded by subjects daily.
  measure: The change in total duration of SRLC per week
  time frame: week 6
  description: Duration of SRLC will be recorded by subjects daily.
  measure: The change in total duration of SRLC per week
  time frame: week 8
  description: Duration of SRLC will be recorded by subjects daily.
  measure: The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
  time frame: week 2
  description: 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).
  measure: The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
  time frame: week 4
  description: 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).
  measure: The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
  time frame: week 6
  description: 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).
  measure: The change in the Short Form 36 Health Survey Questionnaire (SF-36) score
  time frame: week 8
  description: 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).
  measure: The change in the Pittsburg Sleep Quality Index (PSQI)
  time frame: week 2
  description: 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.
  measure: The change in the Pittsburg Sleep Quality Index (PSQI)
  time frame: week 4
  description: 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.
  measure: The change in the Pittsburg Sleep Quality Index (PSQI)
  time frame: week 6
  description: 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.
  measure: The change in the Pittsburg Sleep Quality Index (PSQI)
  time frame: week 8
  description: 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.
  measure: The score of Patient Global Impression of Change (PGIC)
  time frame: week 2
  description: 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).
  measure: The score of Patient Global Impression of Change (PGIC)
  time frame: week 4
  description: 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).
  measure: The score of Patient Global Impression of Change (PGIC)
  time frame: week 6
  description: 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).
  measure: The score of Patient Global Impression of Change (PGIC)
  time frame: week 8
  description: 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).
  arm group label: Shaoyao Gancao Decoction with Addition
  arm group type: Active Comparator
  description: 11g of Shaoyao Gancao Decoction with Addition granules twice daily for 4 weeks
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: 11g of placebo granules twice daily for 4 weeks
  intervention type: Drug
  intervention name: Shaoyao Gancao Decoction with Addition
  description: 11g twice daily for 4 weeks
  arm group label: Shaoyao Gancao Decoction with Addition
  other name: SGDA
  intervention type: Other
  intervention name: Placebo
  description: 11g twice daily for 4 weeks
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zhixiu Lin, PhD
  role: Principal Investigator
  affiliation: Hong Kong Institute of Integrative Medicine
  last name: Zhixiu Lin, PhD
  phone: 35053476
  email: linzx@cuhk.edu.hk
  last name: Tin Muk Ho, Master
  phone: 39433505
  email: raytmho@cuhk.edu.hk
  facility: 
  country: Hong Kong
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Prof. Lin Zhixiu
  investigator title: Professor
  mesh term: Muscle Cramp
  mesh term: Spasm
  sharing ipd: No