Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression
- Conditions
- Fibromyalgia Syndrome
- Interventions
- Drug: Roujin Formula
- Registration Number
- NCT06285045
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
-
- Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for filbromyalgia;
-
- Be over 18 years of age;
-
- Sign informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Roujin Formula group Roujin Formula Roujin Formula : angelica, bupleurum, radix paeoniae alba, etc. Medication method : oral 1 bag ( 150ml ) each time, 2 times a day. Treatment course : 8 weeks.
- Primary Outcome Measures
Name Time Method The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline 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.
The change of the Visual Analogue Scale (VAS) for pain from baseline 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 Outcome Measures
Name Time Method The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline 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.
The change of the Beck depression inventory(BDI) from baseline 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.
The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline 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).
Trial Locations
- Locations (1)
Juan Jiao
🇨🇳Beijing, Beijing, China
Juan Jiao🇨🇳Beijing, Beijing, China