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NCT Number: NCT05508516

Shugan Dingtong Decoction in the Treatment of Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shugan Dingtong decoction

Drug

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

duloxetine hydrochloride

Drug

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

Primary outcomes

  1. Visual analogue scale pain scores

    Time frame: 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 outcomes

  1. Fibromyalgia impact questionnaire

    Time frame: 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.

  2. Fatigue scale-14

    Time frame: 12 Weeks

    The fatigue scale-14 will be used to evaluate physical and mental fatigue. The higher the score, the greater the fatigue.

  3. Pittsburgh sleep quality index

    Time frame: 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%

  4. Traditional Chinses medicine symptom score

    Time frame: 12 Weeks

    Traditional Chinses medicine symptom score is calculated based on the percentage of symptom score reduction

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2022
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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