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.
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.
Study Type
OBSERVATIONAL
Enrollment
308
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.
Patients in the group are treated with the standard level of conventional mood stabilizers provided by psychiatrists according to treatment guidelines for bipolar disorder.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
RECRUITINGChange in the Young Mania Rating Scale (YMRS) scores compared with baseline
To assess the mania symptoms of bipolar disorder patients after 12 weeks of treatment. Patients are assessed with the scale at baseline and week 4, 8, 12(the end of study).
Time frame: 12 weeks
Response rate
Response is defined as a reduction of at least 50% of the YMRS score compared with baseline.
Time frame: 12 weeks
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared with baseline
To assess the depression symptoms of bipolar disorder patients after 12 weeks of treatment. Patients are assessed with the scale at baseline and week 4, 8, 12(the end of study).
Time frame: 12 weeks
Change in total score of the Clinical Global Impression-Severity (CGI-S) scale
To assess the severity of bipolar disorder with the scale at baseline and week 4, 8, 12(the end of study).
Time frame: 12 weeks
Change in total score of the Clinical Global Impression-Improvement (CGI-I) scale
To assess the improvement of bipolar disorder with the scale at baseline and week 4, 8, 12(the end of study).
Time frame: 12 weeks
Change of Traditional Chinese Medicine(TCM) syndromes scale
To assess the Traditional Chinese Medicine syndromes of patients with the scale at baseline and week 4, 8, 12(the end of study).
Time frame: 12 weeks
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