Safety Profile
Information not yet available for this ingredient profile.
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Ivy leaf (Hedera helix) extract standardised for hederacoside C is a well-studied mucolytic and bronchospasmolytic agent used for cough and acute bronchitis. Multiple European RCTs and meta-analyses support its efficacy and safety profile. It is generally well tolerated at standard doses. Rare cases of GI complaints (nausea, vomiting, diarrhoea) and allergic reactions (contact dermatitis) are documented. Avoid raw/fresh ivy — only standardised dry extract preparations are safe for internal use. Contraindicated in known ivy allergy.
Biological and Chemical Classification
- Scientific Name
- Hedera helix
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Botanical
- Evidence consistency: High consistency across studies (100%)
- No significant safety signals identified in the reviewed literature.
The available scientific evidence for Ivy Leaf indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 06 აპრ 2026, 12:10
Evidence Distribution
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Observational / other LOW evidence YELLOWSustainable Extraction of Hedera helix Bioactive Compounds via Synergy of Natural Deep Eutectic Solvent and Ultrasound: Process Optimization, Mechanistic Insights and Anti-Colon… ↗Li T et al.. Sustainable Extraction of Hedera helix Bioactive Compounds via Synergy of Natural Deep Eutectic Solvent and Ultrasound: Process Optimization, Mechanistic Insights and Anti-Colon Cancer Activity.. Int J Mol Sci. 2026. PMID:41828515.PMID 41828515 ↗Journal Int J Mol SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41828515/
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Observational / other LOW evidence YELLOWRandomized, Double-Blind, Multicenter, Phase 3 Study of AG NPP709 Compared With Ivy Leaf Extract in Patients With Acute or Chronic Respiratory Symptoms. ↗Cho YJ et al.. Randomized, Double-Blind, Multicenter, Phase 3 Study of AG NPP709 Compared With Ivy Leaf Extract in Patients With Acute or Chronic Respiratory Symptoms.. J Korean Med Sci. 2026. PMID:41807028.PMID 41807028 ↗Journal J Korean Med SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41807028/
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Observational / other LOW evidence YELLOWAntiparasitic Activity of Hedera helix Extract-Loaded Chitosan Nanoparticles in Experimentally Induced Giardiasis. ↗El-Wahsh HM et al.. Antiparasitic Activity of Hedera helix Extract-Loaded Chitosan Nanoparticles in Experimentally Induced Giardiasis.. Vet Sci. 2026. PMID:41746001.PMID 41746001 ↗Journal Vet SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41746001/
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Observational / other LOW evidence YELLOWHedera helix-derived u03b1-hederin (IVL-11) demonstrates both ex vivo and in vivo flukicidal activities against Fasciola hepatica. ↗Davey SD et al.. Hedera helix-derived u03b1-hederin (IVL-11) demonstrates both ex vivo and in vivo flukicidal activities against Fasciola hepatica.. Biomed Pharmacother. 2026. PMID:41689997.PMID 41689997 ↗Journal Biomed PharmacotherYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41689997/
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Observational / other LOW evidence YELLOWCarrier-Free Supramolecular Hydrogel Self-Assembled from Triterpenoid Saponins from Traditional Chinese Medicine: Preparation, Characterization, and Evaluation of Anti-Inflammatory Activity. ↗Huang Q et al.. Carrier-Free Supramolecular Hydrogel Self-Assembled from Triterpenoid Saponins from Traditional Chinese Medicine: Preparation, Characterization, and Evaluation of Anti-Inflammatory Activity.. Gels. 2026. PMID:41590078.PMID 41590078 ↗Journal GelsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41590078/
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Observational / other LOW evidence YELLOWComprehensive Identification and Abscisic Acid-Responsive Expression Profiling of NAC Transcription Factor in Triterpenoid Saponin in Hedera helix. ↗Deng X et al.. Comprehensive Identification and Abscisic Acid-Responsive Expression Profiling of NAC Transcription Factor in Triterpenoid Saponin in Hedera helix.. Biomolecules. 2025. PMID:41301475.PMID 41301475 ↗Journal BiomoleculesYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41301475/
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Observational / other LOW evidence YELLOWTherapeutic promise of u03b1-hederin in Alzheimer's disease: Insights into inflammation, oxidative stress, and apoptosis modulation. ↗Chettupalli AK et al.. Therapeutic promise of u03b1-hederin in Alzheimer's disease: Insights into inflammation, oxidative stress, and apoptosis modulation.. Biomed Pharmacother. 2025. PMID:41275623.PMID 41275623 ↗Journal Biomed PharmacotherYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41275623/
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Observational / other LOW evidence YELLOWMultilevel trait responses of liana Hedera helix L. to environmental gradients in urban forest ecosystems. ↗Blinkova O et al.. Multilevel trait responses of liana Hedera helix L. to environmental gradients in urban forest ecosystems.. Sci Rep. 2025. PMID:41249241.PMID 41249241 ↗Journal Sci RepYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41249241/
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Observational / other LOW evidence YELLOWData-Driven FTIR Spectroscopy for the Discrimination of Nectars. ↗Szaniawska A et al.. Data-Driven FTIR Spectroscopy for the Discrimination of Nectars.. Molecules. 2025. PMID:41157099.PMID 41157099 ↗Journal MoleculesYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41157099/
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Observational / other LOW evidence YELLOWRole of broad- and needle-leaf morphology in capturing particulate matter and emerging pollutants in urban environments. ↗Kou0144czak B et al.. Role of broad- and needle-leaf morphology in capturing particulate matter and emerging pollutants in urban environments.. Environ Pollut. 2025. PMID:41106798.PMID 41106798 ↗Journal Environ PollutYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41106798/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Ivy Leaf. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Low classification for Ivy Leaf
A score of 1.5 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.