Efficacy and safety of sini powder combined with Xiaoxianxiong decoction for adolescent depression with liver qi stagnation and phlegm-heat obstruction syndrome: a randomized controlled trial - Report - MDSpire

Efficacy and safety of sini powder combined with Xiaoxianxiong decoction for adolescent depression with liver qi stagnation and phlegm-heat obstruction syndrome: a randomized controlled trial

  • By

  • Ruiyu Lin

  • Yangzhen Liu

  • Juncheng Li

  • Jia Gao

  • Liting He

  • Shanying Huang

  • June 12, 2026

  • 0 min

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Effectiveness and Safety of Sini Powder in Combination with Xiaoxianxiong Decoction

Overview

This study evaluates the efficacy and safety of Sini San combined with Xiaoxianxiong Tang as an add-on therapy for adolescents with liver qi stagnation and phlegm-heat depression. Results are based on study findings after 8 weeks of treatment.

Background

Adolescent depression is a growing global concern, impacting cognitive development and social adaptability. Current treatments often include psychological counseling and pharmacotherapy, but many adolescents experience limited efficacy from monotherapy. Traditional Chinese Medicine (TCM) offers a unique approach for adolescents with specific TCM syndromes.

Data Highlights

OutcomeStudy Group (n=30)Control Group (n=30)P-value
CDRS-R Score13.02 ± 3.2521.85 ± 3.56< 0.001
TCM Syndrome Score3.21 ± 1.356.98 ± 1.62< 0.001
PedsQL Score79.35 ± 7.6166.89 ± 7.43< 0.001
Clinical Effective Rate90.0%63.3%0.010
Adverse Events6.7% mild gastrointestinal discomfortNo serious eventsN/A

Key Findings

  • Both treatment and control groups showed significant improvement in depressive symptoms after 4 and 8 weeks (P < 0.001).
  • The study group had a significantly lower CDRS-R score compared to the control group at 8 weeks (13.02 vs. 21.85, P < 0.001).
  • TCM syndrome scores were significantly lower in the study group at 8 weeks (3.21 vs. 6.98, P < 0.001).
  • PedsQL scores were higher in the study group (79.35 vs. 66.89, P < 0.001).
  • The clinical effective rate was significantly higher in the study group (90.0% vs. 63.3%, P = 0.010).
  • Adverse events were mild, with no serious adverse events reported.

Clinical Implications

The findings are based on the study results regarding Sini San combined with Xiaoxianxiong Decoction as an add-on therapy for adolescents with specific TCM syndromes of depression.

Conclusion

Sini San combined with Xiaoxianxiong Decoction is evaluated as an adjunctive treatment for adolescent depression, with findings based on the study results.

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