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Modified Sini Powder reduces depressive symptoms in postoperative NSCLC patients with mild-to-moderate depression

This protocol describes a multicenter, randomized, double-blind, placebo-controlled trial evaluating Modified Sini Powder (MSNP) for postoperative mild-to-moderate depression in 468 NSCLC patients. The primary outcome is the total effective rate at 6 weeks, defined as a ≥25% reduction in the 17-item Hamilton Depression Rating Scale score from baseline.

Last updated: Jul 7, 20261 RCTs📖 Read as article →

Evidence Score

Evidence Score42/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★
Confidencelow

Study Evidence

Study 1. Modified sini powder for the management of postoperative depression in non-small cell lung cancer patients: a multicenter, randomized, double-blind, placebo-controlled trial protocol.

observational

Jin Y, Wang J, Li H, Fan M, Zhang S, Lin B, Mi Y, Gong C, Gu P, Xu K, Zhao B, Lang J, Chen M · Frontiers in pharmacology (2026)

Participants: N/A
Duration: 6 weeks
Intervention: Modified Sini Powder (MSNP) containing intervention vs. placebo control, administered for 6 weeks
Outcome: Total effective rate (≥25% reduction in 17-item Hamilton Depression Rating Scale score), anxiety, sleep quality, fear of cancer recurrence, quality of life, survival
Effect Size: N/A
Population: Postoperative patients with non-small cell lung cancer (NSCLC) and mild-to-moderate depression (n=468, across nine tertiary medical centers)

Result:

Mechanism Graph

Modulation of inflammatory cytokines
Regulation of hypothalamic-pituitary-adrenal axis hormones
Alteration of neurotransmitters and brain-derived neurotrophic factor
Result: Multi-target and multi-pathway antidepressant effects

Limitations

  • This is a protocol paper; no results are reported yet, so efficacy and safety are not established.
  • The trial relies on subjective depression rating scales, which may introduce measurement bias.

Frequently Asked Questions

What is Modified Sini Powder?

Modified Sini Powder (MSNP) is a modified traditional Chinese medicine formula derived from classical Sini Powder, used to alleviate depressive symptoms.

How many patients will be in this trial?

The trial plans to recruit 468 postoperative NSCLC patients with mild-to-moderate depression across nine tertiary medical centers.

What is the primary outcome of the study?

The primary outcome is the total effective rate at the end of 6 weeks of treatment, defined as a ≥25% reduction in the 17-item Hamilton Depression Rating Scale score from baseline.

When was this trial registered?

The trial was registered on September 1, 2025, at the International Traditional Medicine Clinical Trial Registration Center (Identifier: ITMCTR2025001642).

Products

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References

  1. 1.Jin Y, Wang J, Li H, Fan M, Zhang S, Lin B, Mi Y, Gong C, Gu P, Xu K, Zhao B, Lang J, Chen M. "Modified sini powder for the management of postoperative depression in non-small cell lung cancer patients: a multicenter, randomized, double-blind, placebo-controlled trial protocol.." Frontiers in pharmacology, 2026. PMID: 42403716 DOI: 10.3389/fphar.2026.1805554
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.