Fibromyalgia Syndrome
Conditions
Keywords
Fibromyalgia syndrome, Blood deficiency and liver depression；, Roujin Formula, Clinical trial
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.
Interventions
DRUGRoujin 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.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Outcome results
None listed