drugset / Trial / NCT05508516

Shugan Dingtong Decoction in the Treatment of Fibromyalgia

NCT05508516

Phase 0 Completed 72 enrolled China-Japan Friendship Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-09-01
Primary completion
2024-10-18
Completion
2024-10-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Duloxetine Small molecule 20 mg
Subject Shugan Dingtong decoction Traditional medicine (herbal / TCM) 150 ml

Indications