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Shugan Dingtong Decoction in the Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Shugan Dingtong decoction
Duloxetine Hydrochloride
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged 18-70 years old.
  • patients who meet the diagnostic criteria of American College of Rheumatology in 2016.
  • patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi.
  • pain scores between3 and 7 on visual analogue scale.
  • patients sign the informed consent forms.

Exclusion Criteria:

  • pregnant and lactating women.
  • patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system.
  • patients with mental and psychological disorders including cognitive im-pairment, severe depression, somatoform disorders.
  • patients with secondary fibromyalgia resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor.
  • patients with severe pain resulted from diabetic and postherpetic neuralgia.
  • patients who are allergic to the drugs used in this study.
  • patients are participation in any other clinical trials or receive other drugs for the treatment of fibromyalgia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Shugan Dingtong decoction

    duloxetine hydrochloride

    Arm Description

    Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.

    Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Visual analogue scale pain scores
    The primary outcome of this study is visual analogue scale(VAS) pain score used to evalu-ate pain intensity. VAS pain score ranges from 0 to 10, where 0 refers to no pain and 10 refers to unbearable pain.

    Secondary Outcome Measures

    Fibromyalgia impact questionnaire
    The fibromyalgia impact questionnaire will be used to measure physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. This score ranges from 0 to 100 and high scores are related to greater impact on life quality.
    Fatigue scale-14
    The fatigue scale-14 will be used to evaluate physical and mental fatigue. The higher the score, the greater the fatigue.
    Pittsburgh sleep quality index
    Pittsburgh sleep quality index will be used to assess the sleep quality within the past month. The higher the score, the worse sleep quality. A total of PSQI score greater than five yielded a diagnostic sensitivity of 89.6% and specificity of 86.5%
    Traditional Chinses medicine symptom score
    Traditional Chinses medicine symptom score is calculated based on the percentage of symptom score reduction

    Full Information

    First Posted
    August 18, 2022
    Last Updated
    August 18, 2022
    Sponsor
    China-Japan Friendship Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05508516
    Brief Title
    Shugan Dingtong Decoction in the Treatment of Fibromyalgia
    Official Title
    The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China-Japan Friendship Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Fibromyalgia (FM) is a syndrome characterized by chronic and widespread musculoskeletal pain, fatigue sleep disturbances and cognitive and somatic symptoms. It is commonly conjectured that central sensitization is physiological hallmark of FM. Therefore, centrally acting medications including antidepressants and anticonvulsants are used to treat FM via downregulating dorsal horn sensitization and systemic hyperexcitability.However, those drugs are limited in clinical practice resulting from dose-limiting adverse effects and incomplete drug efficacy.Shugan Dingtong decoction(SGDTD) is a Chinese herbal formula and has been used for treatment of FM in clinical practice many years. However, few research can provide high-quality evidence on the efficacy and safety of SGDTD for the treatment of FM. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of SGDTD on FM.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Shugan Dingtong decoction
    Arm Type
    Experimental
    Arm Description
    Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
    Arm Title
    duloxetine hydrochloride
    Arm Type
    Active Comparator
    Arm Description
    Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Shugan Dingtong decoction
    Intervention Description
    Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine Hydrochloride
    Intervention Description
    Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Visual analogue scale pain scores
    Description
    The primary outcome of this study is visual analogue scale(VAS) pain score used to evalu-ate pain intensity. VAS pain score ranges from 0 to 10, where 0 refers to no pain and 10 refers to unbearable pain.
    Time Frame
    12 Weeks
    Secondary Outcome Measure Information:
    Title
    Fibromyalgia impact questionnaire
    Description
    The fibromyalgia impact questionnaire will be used to measure physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. This score ranges from 0 to 100 and high scores are related to greater impact on life quality.
    Time Frame
    12 Weeks
    Title
    Fatigue scale-14
    Description
    The fatigue scale-14 will be used to evaluate physical and mental fatigue. The higher the score, the greater the fatigue.
    Time Frame
    12 Weeks
    Title
    Pittsburgh sleep quality index
    Description
    Pittsburgh sleep quality index will be used to assess the sleep quality within the past month. The higher the score, the worse sleep quality. A total of PSQI score greater than five yielded a diagnostic sensitivity of 89.6% and specificity of 86.5%
    Time Frame
    12 Weeks
    Title
    Traditional Chinses medicine symptom score
    Description
    Traditional Chinses medicine symptom score is calculated based on the percentage of symptom score reduction
    Time Frame
    12 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients aged 18-70 years old. patients who meet the diagnostic criteria of American College of Rheumatology in 2016. patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi. pain scores between3 and 7 on visual analogue scale. patients sign the informed consent forms. Exclusion Criteria: pregnant and lactating women. patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system. patients with mental and psychological disorders including cognitive im-pairment, severe depression, somatoform disorders. patients with secondary fibromyalgia resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor. patients with severe pain resulted from diabetic and postherpetic neuralgia. patients who are allergic to the drugs used in this study. patients are participation in any other clinical trials or receive other drugs for the treatment of fibromyalgia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liu-bo Zhang
    Phone
    86-10-8420-5067
    Email
    zlb597810955@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Shugan Dingtong Decoction in the Treatment of Fibromyalgia

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