Researches on the clinical curative effect of Yin-enching and Heat-cleaning on the treatment of the prodromal phases of bipolar disorder

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300075440

Enrollment

Unknown

Registered

2023-09-05

Start date

2023-09-11

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the prodromal phases of bipolar disorder

Interventions

Test group:Traditional Chinese medicine formula granules+Imitated tablets of quetiapine fumarate

Control group:Chinese herbal placebo+quetiapine fumarate tablets

Eligibility

Sex/Gender

All

Age

16 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1)meeting with the diagnostic criteria for bipolar disorder in the prodromal phase(2)meeting with the diagnostic criteria of syndrome with Yinxuneire(3) 16-40 years old;(4)6 = YMRS = 19 and HAMD-17 = 17;(5)education level at junior high school or above, able to understand the content of the questionnaire;(6)the patient or legal guardian signs an informed consent form and are able to comply with the study protocol

Exclusion criteria

Exclusion criteria: (1)meeting with the diagnostic criteria for mental disorders other than depression and cyclic mood disorder in DSM-5(2)taking psychotropic medicines other than those specified in the study during the study period(3)with a history of severe allergy to traditional Chinese medicine or quetiapine fumarate;(4)suffering from severe or unstable physical diseases;(5)during pregnancy or lactation period;(6)with a risk of serious self injury or suicide

Design outcomes

Primary

Measure	Time frame
The inter group differences on changes of CGI-S scores from baseline to the end of the 8th week;	—

Secondary

Measure	Time frame
Changes in the score of yin deficiency and internal heat syndrome with TCM during the 8-week period;Changes in Quality of Life Scale and SDS scores at each visit point during 8-week treatment period;Changes in YMRS, HAMD-17, BPSS-P, and HAMA scores at visit point during the 8-week treatment period;Changes in the score of yin deficiency and internal heat syndrome with TCM during the 8-week period;The conversion rate of bipolar disorder at the 52nd weekend;Unconverted time of bipolar disorder within 52 weeks;	—

Measure

Time frame

Changes in the score of yin deficiency and internal heat syndrome with TCM during the 8-week period;Changes in Quality of Life Scale and SDS scores at each visit point during 8-week treatment period;Changes in YMRS, HAMD-17, BPSS-P, and HAMA scores at visit point during the 8-week treatment period;Changes in the score of yin deficiency and internal heat syndrome with TCM during the 8-week period;The conversion rate of bipolar disorder at the 52nd weekend;Unconverted time of bipolar disorder within 52 weeks;

—

Countries

China

Contacts

Public ContactMeng Fang

Beijing Anding Hospital,Capital Medical University

fangmeng_fm@163.com+86 134 8875 9571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026