Clinical trial NCT06285045: Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression
Official title: Randomized Controlled Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia syndrome
Blood deficiency and liver depression；
Roujin Formula
Clinical trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
timeFrame: baseline,4 weeks, 8 weeks, 12 weeks
measure: The change of the Visual Analogue Scale (VAS) for pain from baseline
timeFrame: baseline,4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline
timeFrame: baseline,4 weeks, 8 weeks, 12 weeks
measure: The change of the Beck depression inventory(BDI) from baseline
timeFrame: baseline,4 weeks, 8 weeks, 12 weeks
measure: The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline
timeFrame: baseline,4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Juan Jiao
state: Beijing
Study officials:
References: