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The efficacy and safety of the Shugan Dingtong Decoction in the treatment of fibromyalgia based on functional MRI

The efficacy and safety of the Shugan Dingtong Decoction in the treatment of fibromyalgia based on functional MRI

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063270
Enrollment
Unknown
Registered
2022-09-02
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia syndrome

Interventions

treat group :Shugan Dingtong decoction
control group :Duloxetine Hydrochloride

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18–70 years; 2. Patients who meet the diagnostic criteria of American College of Rheumatology in 2016; 3. Patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi; 4. Pain scores 3-7 on visual analogue scale (VAS); 5. Patients sign the informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system; 3. Patients with mental and psychological disorders including cognitive impairment, severe depression, somatoform disorders; 4. Patients with secondary FM resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor; 5. Patients with severe pain resulted from diabetic and postherpetic neuralgia; 6. Patients who are allergic to the drugs used in this study; 7. Patients are participation in any other clinical trials or receive other drugs for the treatment of FM; 8. Patients with implanted metal in the body or a history of claustrophobia and panic attacks that prevent fMRI examinations.

Design outcomes

Primary

MeasureTime frame
Visual analog pain score;

Secondary

MeasureTime frame
Fibromyalgia Quality of Life Score;FS-14 Fatigue Score;Sleep quality PSQI score;TCM Syndrome Score;

Countries

China

Contacts

Public ContactXu Yuan

China-Japan Friendship Hospital

597810955@qq.com+86 10 84205067

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026