NCT05508516

Shugan Dingtong Decoction in the Treatment of Fibromyalgia

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Shugan Dingtong decoction	Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
DRUG	Duloxetine Hydrochloride	Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-10-18
• Completion: 2024-10-18
• First posted: 2022-08-19
• Last updated: 2024-11-19

Locations

1 site across 1 country: China