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A randomized, double-blind, placebo-controlled clinical study of Pinglu Hua Yu Fang in the treatment of adolescents with mild to moderate mixed anxiety and depressive disorder (Pattern of Retained Fluid in the Interior).

A randomized, double-blind, placebo-controlled clinical study of Pinglu Hua Yu Fang in the treatment of adolescents with mild to moderate mixed anxiety and depressive disorder (Pattern of Retained Fluid in the Interior).

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000976
Enrollment
Unknown
Registered
2026-04-16
Start date
2025-08-15
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

mixed anxiety and depressive disorder

Interventions

Treatment group:Ping Lu Hua Yu prescription Chinese medicine decoction
Placebo group:Placebo in traditional Chinese medicine

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 19 Years

Inclusion criteria

Inclusion criteria: (1) Age 12-19 years old, gender is not limited, (2) meet the Western medicine diagnostic criteria for mixed anxiety and depression disorder; (3) Meet the diagnostic criteria of TCM for suspension of water drinking; (4) Patients with mild to moderate mixed anxiety and depression disorder: the baseline anxiety self-rating scale (SAS) score = 50 points and = 69 points, and the depression self-rating scale SDS = 50 points and = 69 points. (5) Voluntary participation, with both patients and guardians signing informed consent forms.

Exclusion criteria

Exclusion criteria: (1) Previous mental disorders or other emotional disorders, or psychotic symptoms; (2) Have a suicidal plan or history of suicide; or Suicide Risk Assessment Scale (NGASR) =9; (3) Previous history of traumatic brain injury and organic brain diseases, such as epilepsy; (4) Those who suffer from diseases that may cause anxiety and depression, such as hyperthyroidism, hypothyroidism, and primary diseases such as cardiovascular, pulmonary, liver, kidney, and hematopoietic system or other physical diseases; (5) Liver function (alanine aminotransferase ALT or aspartate aminotransferase AST >1.5 times the upper limit of normal value) or abnormal renal function tests (creatinine Cr >upper limit of normal value); (6) Use of drugs or treatments that may affect the evaluation of the effectiveness of the trial drug, such as anti-anxiety and depressants, analgesics, and sedatives within 1 month before the screening period; and traditional Chinese medicine decoctions, proprietary Chinese medicines, and acupuncture treatments for the treatment of anxiety and depression; (7) Participated in other clinical trials within 1 month before the screening period; (8) Suspected or known allergy to the ingredients of this drug; (9) According to the judgment of the investigator, it is not suitable to participate in this researcher; (10) Female pregnancy or lactation. (11) Those who weigh = 30 kg are excluded.

Design outcomes

Primary

MeasureTime frame
Self-Rating Depression Scale;

Secondary

MeasureTime frame
Self-Rating Anxiety Scale;Hamilton Anxiety Scale;Hamilton Depression Scale;Pittsburgh sleep quality index;Cornell Medical Index;TCM symptom score scale;

Countries

China

Contacts

Public ContactJin Sheng Kang

Dade Road General Hospital of Guangdong Provincial Hospital of Traditional Chinese Medicine, No. 111 Dade Road, Yuexiu District, Guangzhou

513823677@qq.com+86 150 0273 7239

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026