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NCT Number: NCT06285045

Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression

To evaluate the efficacy and safety of Roujin Formula in the treatment of fibromyalgia syndrome(FMS)patients with blood deficiency and liver depression through a randomized,single-blind,placebo-parallel controlled exploratory clinical trial study,and to provide reliable clinical evidence for the treatment of fibromyalgia syndrome with Roujin Formula. 48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan Jiao

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for filbromyalgia;
  • 2. Be over 18 years of age;
  • 3. Sign informed consent.

Exclusion criteria

  • 1.patients with rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, ankylosing spondylitis and other rheumatic diseases ;
  • 2.severe liver and kidney dysfunction;
  • 3.severe cardiovascular and cerebrovascular diseases and other diseases ;
  • 4.pregnant or lactating women ;
  • 5.had taken drugs for the treatment of this disease in the last 4 weeks.

Treatment and study plan

Roujin Formula

Drug

48 eligible participants with FMS of blood deficiency and liver depression syndrome were selected and randomly divided into treatment group(n=24)and control group(n=24). The treatment group was given Roujin Foumula 150mL,twice a day; The control group was given Roujin Foumula placebo 150mL,twice a day,the study period was 8 weeks. The evaluation points were 0 weeks,4 weeks,and 8 weeks of treatment,and follow-up to 12 weeks. To evaluate the effect changes before and after treatment,FIQR score、VAS score、PSQI score、BDI score and SF-36 PCS、MCS score were used as secondary efficacy evaluation indexes. SPSS23.0 was used to analyze the data.

Primary outcomes

  1. The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline

    Time frame: baseline,4 weeks, 8 weeks, 12 weeks

    A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.

  2. The change of the Visual Analogue Scale (VAS) for pain from baseline

    Time frame: baseline,4 weeks, 8 weeks, 12 weeks

    Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.

Secondary outcomes

  1. The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline

    Time frame: baseline,4 weeks, 8 weeks, 12 weeks

    Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.

  2. The change of the Beck depression inventory(BDI) from baseline

    Time frame: baseline,4 weeks, 8 weeks, 12 weeks

    The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.

  3. The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline

    Time frame: baseline,4 weeks, 8 weeks, 12 weeks

    The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Randomized Controlled Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 29, 2024
Registry last updated
Mar 5, 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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