# Efficacy and safety of SH003 on immune function: study protocol for a randomized, double-blind placebo-controlled clinical trial

**Authors:** Chunhoo Cheon, Seong-Gyu Ko

PMC · DOI: 10.1186/s12906-025-05032-4 · BMC Complementary Medicine and Therapies · 2025-07-30

## TL;DR

This clinical trial tests SH003, a herbal compound, for its ability to safely improve immune function in people with mildly weakened immunity.

## Contribution

This is the first clinical trial to evaluate SH003's immune-enhancing effects in a general population with mild immune impairment.

## Key findings

- The trial will assess changes in natural killer cell activity as the primary outcome.
- Secondary outcomes include cytokine levels and inflammation markers.
- Safety will be evaluated through vital signs and lab tests.

## Abstract

The immune system is essential for defending the body against pathogens and maintaining homeostasis. Recent global public health challenges have increased interest in natural products that enhance immune function. SH003, a compound derived from Astragalus membranaceus, Angelica gigas Radix, and Trichosanthis Radix, has shown potential as an immunomodulatory agent. This study aims to evaluate the efficacy and safety of SH003 in improving immune function in individuals with a mildly weakened immune systems.

This randomized, double-blind, placebo-controlled trial will be conducted over 8 weeks with 120 participants aged 19 to 75 years who have experienced two or more upper respiratory infections in the past year. Participants will be randomly assigned to receive either SH003 or a placebo. The primary outcome is the change in natural killer cell activity. Secondary outcomes include cytokines levels (IL-2, IL-12, IFN-γ, TNF-α), inflammation markers (CRP, ESR), and stress and respiratory symptoms. Safety outcomes will be monitored through vital signs and laboratory tests.

This study represents the first clinical trial to evaluate the immune-enhancing effects of SH003 in a general population with mild immune system impairment. The results could offer valuable insights into the potential of SH003 as a novel immune support intervention.

Clinical Research Information Service (registration number: KCT0009424, May 10, 2024, https://cris.nih.go.kr). Retrospectively registered.

## Linked entities

- **Proteins:** IL2 (interleukin 2), IL12 (Interleukin 12 level), IFNG (interferon gamma), TNF (tumor necrosis factor)
- **Chemicals:** SH003 (PubChem CID 23676156)
- **Species:** Astragalus membranaceus (taxon 649199)

## Full-text entities

- **Genes:** SLC17A5 (solute carrier family 17 member 5) [NCBI Gene 26503] {aka AST, ISSD, NSD, SD, SIALIN, SIASD}, IL2 (interleukin 2) [NCBI Gene 3558] {aka IL-2, TCGF, lymphokine}, TNF (tumor necrosis factor) [NCBI Gene 7124] {aka DIF, IMD127, TNF-alpha, TNFA, TNFSF2, TNLG1F}, CRP (C-reactive protein) [NCBI Gene 1401] {aka PTX1}, IL12B (interleukin 12B) [NCBI Gene 3593] {aka CLMF, CLMF2, IL-12B, IMD28, IMD29, NKSF}, IFNG (interferon gamma) [NCBI Gene 3458] {aka IFG, IFI, IMD69}
- **Diseases:** hypertension (MESH:D006973), leukemia (MESH:D007938), MERS (MESH:D018352), WURSS-21 (MESH:D012818), COVID-19 (MESH:D000086382), otitis media (MESH:D010033), rhinitis (MESH:D012220), FA (MESH:C537270), oncological (MESH:D000072716), respiratory infections (MESH:D012141), hypersensitivity (MESH:D004342), pharyngitis (MESH:D010612), cancer (MESH:D009369), sinusitis (MESH:D012852), inflammation (MESH:D007249), alcohol or substance abuse (MESH:D019966), common cold (MESH:D003139), influenza (MESH:D007251), laryngitis (MESH:D007827), tonsillitis (MESH:D014069), uncontrolled diabetes (MESH:D003920), thyroid disorders (MESH:D013959), immune system impairment (MESH:D007154)
- **Chemicals:** PGA (MESH:D011454), alcohol (MESH:D000438), ethanol (MESH:D000431), lactose (MESH:D007785), Angelica Gigas Radix (-), creatinine (MESH:D003404), maltodextrin (MESH:C008315), microcrystalline cellulose (MESH:C109691), IP (MESH:C041508)
- **Species:** Angelica gigas (species) [taxon 85712], Homo sapiens (human, species) [taxon 9606], Astragalus membranaceus (species) [taxon 649199]
- **Mutations:** G469A
- **Cell lines:** K562 — Homo sapiens (Human), Blast phase chronic myelogenous leukemia, BCR-ABL1 positive, Cancer cell line (CVCL_0004)

## Full text

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## Figures

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## References

1 references — full list in the complete paper: https://tomesphere.com/paper/PMC12312515/full.md

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Source: https://tomesphere.com/paper/PMC12312515