NCT06285045

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-08-31
• Completion: 2019-08-31
• First posted: 2024-02-29
• Last updated: 2024-03-05

Locations

1 site across 1 country: China