Shugan Dingtong Decoction in the Treatment of Fibromyalgia

Study Overview
=================
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.

Official Title
-----------------
The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Shugan Dingtong decoction
* Drug: Duloxetine Hydrochloride


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shugan Dingtong decoction<br>Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks. | Drug: Shugan Dingtong decoction<br>* Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.<br>|
| Active Comparator: duloxetine hydrochloride<br>Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks. | Drug: Duloxetine Hydrochloride<br>* Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 Weeks | 
| Fatigue scale-14 | The fatigue scale-14 will be used to evaluate physical and mental fatigue. The higher the score, the greater the fatigue. | 12 Weeks | 
| 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% | 12 Weeks | 
| Traditional Chinses medicine symptom score | Traditional Chinses medicine symptom score is calculated based on the percentage of symptom score reduction | 12 Weeks |