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

NCT06285045 | Completed

• 1 other identifier: 2060302-1703-05
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia syndrome; Blood deficiency and liver depression；; Roujin Formula; Clinical trial

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

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

  baseline,4 weeks, 8 weeks, 12 weeks

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

  baseline,4 weeks, 8 weeks, 12 weeks

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

  baseline,4 weeks, 8 weeks, 12 weeks

Study Arms (2)

Roujin Formula group

EXPERIMENTAL

Roujin Formula : angelica, bupleurum, radix paeoniae alba, etc. Medication method : oral 1 bag ( 150ml ) each time, 2 times a day. Treatment course : 8 weeks.

Drug: Roujin Formula

Control group

NO INTERVENTION

Placebo : According to the internationally accepted standard, one-tenth of the dose of Roujin Formula was used to prepare a placebo, which was similar to Roujin Formula in appearance, color, taste or smell, and packaging. Medication method : oral 1 bag ( 150ml ) each time, 2 times a day. Treatment course : 8 weeks.

Interventions

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.

Roujin Formula group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Juan Jiao

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: October 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

CN (1)