Shugan Dingtong Decoction in the Treatment of Fibromyalgia

NCT ID: NCT05508516

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-10-18

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shugan Dingtong decoction

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

Group Type: EXPERIMENTAL

Shugan Dingtong decoction

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Duloxetine Hydrochloride

Intervention Type: DRUG

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

Interventions

Shugan Dingtong decoction

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

Intervention Type: DRUG

Duloxetine Hydrochloride

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuan Xu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Wang Z, Lan T, Zhang Y, Guo Z, Yu H, Sun G, Wang Z, Yan Z, Tao Q, Xu Y. Osteoarthritis and Degree of Fatigue are Associated with Pain Levels in Patients with Fibromyalgia Syndrome: A Cross-Sectional Study of 394 Patients. Int J Gen Med. 2025 Jan 31;18:497-507. doi: 10.2147/IJGM.S503902. eCollection 2025.

Reference Type: DERIVED

PMID: 39906173 (View on PubMed)

Other Identifiers

LZhang

Identifier Type: -

Identifier Source: org_study_id