NCT05247593

A Study of Dayingpian Treating Bipolar Disorder

The Efficacy and Safety of Dayingpian in The Treatment of Bipolar Disorder

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 308 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this cohort study is to evaluate the efficiency and safety of Dayingpian to provide evidence-based medical evidence for the subsequent drug development.

Detailed description

Dayingpian is a kind of formula in traditional Chinese medicine with the effect of promoting blood circulation and reducing blood stasis. It has been prescribed as an add-on in the treatment of mental disorders such as bipolar disorder. However, there is not yet much high-quality evidence of the clinical effectiveness of Dayingpian treatment. In this study, we conduct a prospective, real-world longitudinal cohort study at Shanghai Mental Health Center in China to investigate the efficacy and safety of Dayingpian for bipolar disorder patients. The observation period is 12 weeks and all participants are evaluated every 4 weeks.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Dayingpian	The actual dosage of Dayingpian is adjusted according to the patient's condition. The recommended dosage of Dayingpian is 5-10 tablets each time, 2-3 times a day.
DRUG	conventional mood stabilizers	Patients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2022-02-21
• Last updated: 2022-10-19

Locations

1 site across 1 country: China