<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/NCT04500730</url>
  </required_header>
  <id_info>
    <org_study_id>SRLC study</org_study_id>
    <nct_id>NCT04500730</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps</brief_title>
  <official_title>Effectiveness of Herbal Medicine (Shaoyao Gancao Decoction Jiawei) in Sleep-related Leg Cramps - A Pilot Study</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep-related leg cramps (SRLCs) are a sleep-related movement disorder whereby painful&#xD;
      contractions of the calf or foot muscles arise at sleep onset and during sleep and awaken the&#xD;
      patient, interrupting sleep. Application of oral administration with Chinese herbal medicine&#xD;
      can enhance the effectiveness and efficacy in treatment of SRLCs.This study will using&#xD;
      Shaoyao Gancao Prescription Jiawei by adding Pueraria montana, Salvia Miltiorrhiza, into&#xD;
      Shaoyao Gancao. The study aims to evaluate the effectiveness of a Shaoyao Gancao Prescription&#xD;
      Jiawei in relieving leg cramps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in Yan Oi Tong Mrs Shirley W K Siu Medical Centre. All&#xD;
      participants diagnosed with sleep-related leg cramp will be screened for eligibility criteria&#xD;
      from the general public or referred patients via daily outpatient services. This will be a&#xD;
      prospective trial in patients with sleep-related leg cramps (SRLCs). 30 subjects will be&#xD;
      recruited from Yan Oi Tong Mrs Shirley W K Siu Medical Centre. The medication will be taken&#xD;
      twice daily for 28 consecutive days. Each prescription will consist of 4 herbal granules.&#xD;
      Study follow up will be offered every 7 days till 56th day after enrolment. Daily leg cramps&#xD;
      log will be filled in by each individual everyday from day 0 to day 56.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Score (VAS) Assessment</measure>
    <time_frame>4 Weeks</time_frame>
    <description>The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Form 36 Health Survey Questionnaire</measure>
    <time_frame>8 weeks</time_frame>
    <description>to assess the health-related quality of life of subjects, it ranges from 0-100 scores, the higher the score, the more disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Score (VAS) Assessment</measure>
    <time_frame>8 weeks</time_frame>
    <description>The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Sleep-related Leg Cramps</condition>
  <arm_group>
    <arm_group_label>Shaoyao Gancao Decoction Jiawei</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shaoyao Gancao Decoction Jiawei by adding Pueraria montana, Salvia Miltiorrhiza, into Shaoyao Gancao.&#xD;
The medication will be taken twice daily for 28 consecutive days. Each prescription will consist of 4 herbal granules.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Shaoyao Gancao Decoction Jiawei</intervention_name>
    <description>Study herb will be prescribed for 28 consecutive days. Study follow up will be offered every 7 days till 56th day after enrolment.&#xD;
Daily leg cramps log will be filled in by each individual everyday from day 0 to day 56.</description>
    <arm_group_label>Shaoyao Gancao Decoction Jiawei</arm_group_label>
    <other_name>Nong's Concentrated Chinese Medicine Granules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 60-80&#xD;
&#xD;
          2. Complain of muscular spasm and contracture of a limb with difficulty in relaxation and&#xD;
             movement during night time, caused by wind-cold dampness chiefly involving the sinews&#xD;
&#xD;
          3. SRLCs occur at least once in the past 7 days or twice in the past 14 days&#xD;
&#xD;
          4. Visual Analogue Scale (VAS) for leg cramp ≥ 5 (0-10) at the last attack&#xD;
&#xD;
          5. Both gender but menopause or sterilization for female subjects&#xD;
&#xD;
          6. Able to fill up the VAS for leg cramp&#xD;
&#xD;
          7. Written informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Known mental disorder 2. Known serious organic disease including severe coronary&#xD;
        function impairment, post-stroke depression and dementia, and auto-immune diseases 3. Known&#xD;
        history of renal or liver function impairment; 4. Patients whose blood tests show exclusion&#xD;
        criteria 5. Currently taking anticoagulant or antiplatelet 6. Any contraindications for&#xD;
        taking herb confirmed by investigator&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 26, 2020</last_update_submitted>
  <last_update_submitted_qc>August 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2020</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>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04500730
org study id: SRLC study
nct id: NCT04500730
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analogue Score (VAS) Assessment
time frame: 4 Weeks
description: The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.
measure: Short Form 36 Health Survey Questionnaire
time frame: 8 weeks
description: to assess the health-related quality of life of subjects, it ranges from 0-100 scores, the higher the score, the more disability
measure: Visual Analogue Score (VAS) Assessment
time frame: 8 weeks
description: The pain VAS is a unidimensional measure of pain intensity, it ranges from 0 to 10cm,high score means more painful.
arm group label: Shaoyao Gancao Decoction Jiawei
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: Shaoyao Gancao Decoction Jiawei
description: 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.
arm group label: Shaoyao Gancao Decoction Jiawei
other name: Nong's Concentrated Chinese Medicine Granules
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Prof. Lin Zhixiu
investigator title: Associate professor
mesh term: Muscle Cramp