Shugan Dingtong Decoction in the Treatment of Fibromyalgia

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05508516

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Drug: Shugan Dingtong decoction Drug: Duloxetine Hydrochloride	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Shugan Dingtong decoction Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.	Drug: Shugan Dingtong decoction Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
Active Comparator: duloxetine hydrochloride Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.	Drug: Duloxetine Hydrochloride Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.

Arm

Intervention/Treatment

Experimental: Shugan Dingtong decoction

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

Drug: Shugan Dingtong decoction

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

Active Comparator: duloxetine hydrochloride

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

Drug: Duloxetine Hydrochloride

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

Outcome Measures

Primary Outcome Measures

Visual analogue scale pain scores [12 Weeks]
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.

Secondary Outcome Measures

Fibromyalgia impact questionnaire [12 Weeks]
The fibromyalgia impact questionnaire will be used to measure physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. This score ranges from 0 to 100 and high scores are related to greater impact on life quality.
Fatigue scale-14 [12 Weeks]
The fatigue scale-14 will be used to evaluate physical and mental fatigue. The higher the score, the greater the fatigue.
Pittsburgh sleep quality index [12 Weeks]
Pittsburgh sleep quality index will be used to assess the sleep quality within the past month. The higher the score, the worse sleep quality. A total of PSQI score greater than five yielded a diagnostic sensitivity of 89.6% and specificity of 86.5%
Traditional Chinses medicine symptom score [12 Weeks]
Traditional Chinses medicine symptom score is calculated based on the percentage of symptom score reduction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

China-Japan Friendship Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liu-bo Zhang, MD, China-Japan Friendship Hospital

ClinicalTrials.gov Identifier:

NCT05508516

Other Study ID Numbers:

LZhang

First Posted:

Aug 19, 2022

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibromyalgia

Myofascial Pain Syndromes

Duloxetine Hydrochloride

Study Results

No Results Posted as of Aug 19, 2022