NCT05508516|CompletedEarly Phase 1
Shugan Dingtong Decoction in the Treatment of Fibromyalgia
The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia
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The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia
Sponsor study identifier
interventional
72
1 country
1
Study Start
September 1, 2022
Actual (reported)Primary Completion
October 18, 2024
Actual (reported)Study Completion
October 18, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 18, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 18, 2022
Actual (reported)August 19, 2022
Actual (reported)September 1, 2022
Actual (reported)October 18, 2024
Actual (reported)October 18, 2024
Actual (reported)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
Fibromyalgia impact questionnaire
12 Weeks
Fatigue scale-14
12 Weeks
Pittsburgh sleep quality index
12 Weeks
Traditional Chinses medicine symptom score
12 Weeks
Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.
Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
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.
72 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2022
First Posted
August 19, 2022
Study Start
September 1, 2022
Actual (reported)A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 18, 2024
Actual (reported)Study Completion
October 18, 2024
Actual (reported)Last Updated
November 19, 2024
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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