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
About this trial
This is an interventional treatment trial for Fibromyalgia
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.
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
NCT ID
NCT05508516
First Posted
August 18, 2022
Last Updated
August 18, 2022
Sponsor
China-Japan Friendship Hospital
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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