Summary
Saffron has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Anxiety Disorders. ClinicalTrials.gov lists 2 registered trials linking Saffron to Anxiety Disorders: 2 are terminated, withdrawn, suspended or of unknown status. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 50 participants. Registration activity spans 2016 to 2022. The literature layer holds 6 publications for this pair: 4 Cochrane reviews and 2 clinical trial publications. Publication years run from 2018 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Anxiety ranks 535 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: GAD: spontaneous remission in ~25-30% at 1 year without treatment; social anxiety: 36% remission at 12 years untreated; panic disorder: 50-65% spontaneous partial remission but relapse common; 40-60% remain symptomatic at 5 years.
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 31.0 (trials 2.0, literature 24.0, tier 5, approved bonus 0.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 2 other |
| Linked publications | 6 (4 Cochrane reviews, 2 clinical trial publications) |
| Agent type | Supplement (Herbal) |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Anxiety: a look at epidemiological factors and alternate treatments · Halma M, Covarrubias A, Selem E, Varon J · 2025 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT05690126 | Effect of Saffron Extract Supplementation on Emotional Well-being Alterations 2022 | status unknown | Not applicable | 50 |
| NCT02800733 | Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD) 2016 | status unknown | PHASE2, PHASE3 | 40 |
Published literature
- Cochrane review Effect of saffron on depression, anxiety and mood disorder: a GRADE assessed systematic review and meta-analysis of 34 randomized controlled trialsMahmoudi R, Mohammadi-Sartang M, Servatyari K et al. · Nutritional neuroscience · 2026 · PMID 41693488
- Cochrane review New horizons for the study of saffron (Crocus sativus L.) and its active ingredients in the management of neurological and psychiatric disorders: A systematic review of clinical evidence and mechanismsHan S, Cao Y, Wu X et al. · Phytotherapy research : PTR · 2024 · PMID 38424688
- Cochrane review Medicinal herbs for the treatment of anxiety: A systematic review and network meta-analysisZhang W, Yan Y, Wu Y et al. · Pharmacological research · 2022 · PMID 35378276
- Clinical trial publication Effect of crocin versus fluoxetine in treatment of mild to moderate obsessive-compulsive disorder: A double blind randomized clinical trialKazemi F, Vosough I, Sepahi S et al. · Human psychopharmacology · 2021 · PMID 33599345
- Clinical trial publication affron(®), a standardised extract from saffron (Crocus sativus L.) for the treatment of youth anxiety and depressive symptoms: A randomised, double-blind, placebo-controlled studyLopresti AL, Drummond PD, Inarejos-García AM et al. · Journal of affective disorders · 2018 · PMID 29510352
- Cochrane review Herbal medicine for depression and anxiety: A systematic review with assessment of potential psycho-oncologic relevanceYeung KS, Hernandez M, Mao JJ et al. · Phytotherapy research : PTR · 2018 · PMID 29464801
Mechanism and notes
Recorded mechanism or class: Anxiety: a look at epidemiological factors and alternate treatments · Halma M, Covarrubias A, Selem E, Varon J · 2025.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Saffron approved for Anxiety Disorders?
Saffron has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Anxiety Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Saffron in clinical trials for Anxiety Disorders?
ClinicalTrials.gov lists 2 registered trials linking Saffron to Anxiety Disorders: 2 are terminated, withdrawn, suspended or of unknown status. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 50 participants. Registration activity spans 2016 to 2022.
What does the evidence show for Saffron in Anxiety Disorders?
Trials of Saffron in Anxiety Disorders are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.