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

Fibromyalgia Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06285045
• Other study ID #: 2060302-1703-05
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2024
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Juan Jiao	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline	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.	baseline,4 weeks, 8 weeks, 12 weeks
Primary	The change of the Visual Analogue Scale (VAS) for pain from baseline	Pain VAS, range, 0 to 10 cm, where higher scores indicated the perceived pain to be more severe.	baseline,4 weeks, 8 weeks, 12 weeks
Secondary	The change of the Pittsburgh Sleep Quality Index(PSQI) from baseline	Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.	baseline,4 weeks, 8 weeks, 12 weeks
Secondary	The change of the Beck depression inventory(BDI) from baseline	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.	baseline,4 weeks, 8 weeks, 12 weeks
Secondary	The change of the Short Form-36 Health Status Questionnaire(SF-36) from baseline	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).	baseline,4 weeks, 8 weeks, 12 weeks