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Efficacy and safety of Saffron Supplementation on Immunological and Clinical outcomes of patients with Dry Eye Syndromes: Randomised clinical trial.

Efficacy and safety of Saffron Supplementation on Immunological and Clinical outcomes of patients with Dry Eye Syndromes: Randomised clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110811007297N11
Enrollment
120
Registered
2026-01-31
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye syndrome. Dry eye syndrome

Interventions

Intervention 1: First intervention group: Participants in this group will receive 30 mg/day of standardized saffron extract. The daily dose will be divided into three equal doses of 10 mg and administ

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: OSDI score > 12 Schirmer test < 10 mm/5 minutes.

Exclusion criteria

Exclusion criteria: Corneal ulcer Glaucoma Autoimmune diseases Uncontrolled diabetes Pregnancy Breastfeeding Allergy or sensitivity to the study medications Previous eye surgery Cancer

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index. Timepoint: Before the intervention and 4 , 8 weeks after intervention. Method of measurement: The OSDI questionnaire.;Tear Break-Up Time. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Physical exam with slit lamp.;Schirmer Test. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Measurement with Schirmer Test strip.

Secondary

MeasureTime frame
Tear IL1 level. Timepoint: 8 weeks. Method of measurement: Human Interleukin-1 ELISA Kit (Sigma-Aldrich).;Tear IL6 level. Timepoint: 8 weeks. Method of measurement: Human Interleukin-6 ELISA Kit (Sigma-Aldrich).;Tear TNF level. Timepoint: 8 weeks. Method of measurement: Human TNF ELISA Kit (Sigma-Aldrich).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Heydari

Shiraz University of Medical Sciences

drmojtabaheydari@gmail.com+98 71 3230 2830

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026