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Therapy of replenishing yin and regulating yang for manic episode in bipolar disorder: a randomized controlled trial

Therapy of replenishing yin and regulating yang for manic episode in bipolar disorder: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049300
Enrollment
Unknown
Registered
2021-07-29
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

bipolar disorder

Interventions

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for manic episodes of bipolar disorder; 2. Meet the diagnostic criteria for the syndrome of madness and fire and injury to the yin; 3. No gender restriction, aged between 18-60 years; 4. YMRS score >= 20 points; 5. Voluntarily participate in clinical research, and the guardian signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with mental disorders caused by organic brain diseases; 2. History of dependence on psychoactive substances such as alcohol in the past 1 year; 3. Those who have serious self-harm or hurt others; 4. Those with serious physical diseases, or with obvious abnormal liver and kidney functions (more than 1.5 times higher than the normal value); 5. Have taken traditional Chinese medicine in the past month; 6. Those who are allergic to traditional Chinese medicine; 7. Pregnant or lactating patients; 8. Those who have participated in clinical trials of other drugs in the past month.

Design outcomes

Primary

MeasureTime frame
Changes in Young's mania rating scale scores;

Secondary

MeasureTime frame
TCM syndrome rating scale score change;Treatment emergent symptom scale score change;Changes of serum C-reactive protein, IL-6 and TNF-a levels;Changes in the intestinal flora;

Countries

China

Contacts

Public ContactChen Pei

Beijing Anding Hospital, Capital Medical University

bettereveryday@163.com+86 10 58303111

Outcome results

None listed

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