Shugan Dingtong Decoction in the Treatment of Fibromyalgia

NCT05508516 | Completed Early Phase 1

• 1 other identifier: LZhang
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fibromyalgia impact questionnaire

  12 Weeks

• Fatigue scale-14

  12 Weeks

• Pittsburgh sleep quality index

  12 Weeks

• Traditional Chinses medicine symptom score

  12 Weeks

Study Arms (2)

Shugan Dingtong decoction

EXPERIMENTAL

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

Drug: Shugan Dingtong decoction

duloxetine hydrochloride

ACTIVE COMPARATOR

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

Drug: Duloxetine Hydrochloride

Interventions

Shugan Dingtong decoction DRUG

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

Shugan Dingtong decoction

Duloxetine Hydrochloride DRUG

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

duloxetine hydrochloride

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

• 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.

  PMID: 39906173 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: September 1, 2022
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)