Shugan Dingtong Decoction in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05508516
• Other study ID #: LZhang
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2022
• Source: China-Japan Friendship Hospital
• Contact: Liu-bo Zhang
• Phone: 86-10-8420-5067
• Email: zlb597810955[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Shugan Dingtong decoction
Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
• Duloxetine Hydrochloride
Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Traditional Chinses medicine symptom score	Traditional Chinses medicine symptom score is calculated based on the percentage of symptom score reduction	12 Weeks