Evaluation of the Impact of Saffron on Quality of Life in Patients with Celiac Disease

Evaluation of the Impact of Saffron on Quality of Life in Patients with Celiac Disease: A Pilot, Randomized Double-Blind Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260212068840N1

Enrollment

Registered

2026-05-28

Start date

2026-07-23

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

celiac disease. Celiac disease

Interventions

Intervention 1: Intervention group: Participants in this group receive saffron capsules at a dose of 50 mg twice daily for 8 weeks. All participants continue standard treatment for celiac disease, inc

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of celiac disease, with impaired quality of life.Ability to provide written informed consent and willingness and ability to adhere to the study intervention and assessment schedule.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
AgeImprovement in quality of life in patients with celiac disease measured by CD-QOL questionnaire. Timepoint: Baseline, Week 4, Week 8. Method of measurement: Measured using the Persian version of the CD-QOL questionnaire; higher scores indicate better quality of life.;Change in anxiety severity in patients with celiac disease. Timepoint: Baseline, Week 4, Week 8. Method of measurement: Measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire; scores range from 0–21, with higher scores indicating greater anxiety.;Change in depression severity in patients with celiac disease. Timepoint: Baseline, Week 4, Week 8. Method of measurement: Measured using the Patient Health Questionnaire-9 (PHQ-9); scores range from 0–27, with higher scores indicating more severe depression.;Change in gut microbiota composition in patients with celiac disease. Timepoint: Baseline and post-intervention (Week 8). Method of measurement: Measured ??????? stool sample analysis using 16S rRNA sequencing to assess microbiome composition and diversity.;Assessment of treatment-emergent adverse events related to saffron use. Timepoint: Throughout the study (Baseline, Week 4, Week 8, and as needed). Method of measurement: Assessed using Common Terminology Criteria for Adverse Events (CTCAE), including gastrointestinal, psychiatric, neurological, and immune system disorders.	—

Measure

Time frame

AgeImprovement in quality of life in patients with celiac disease measured by CD-QOL questionnaire. Timepoint: Baseline, Week 4, Week 8. Method of measurement: Measured using the Persian version of the CD-QOL questionnaire; higher scores indicate better quality of life.;Change in anxiety severity in patients with celiac disease. Timepoint: Baseline, Week 4, Week 8. Method of measurement: Measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire; scores range from 0–21, with higher scores indicating greater anxiety.;Change in depression severity in patients with celiac disease. Timepoint: Baseline, Week 4, Week 8. Method of measurement: Measured using the Patient Health Questionnaire-9 (PHQ-9); scores range from 0–27, with higher scores indicating more severe depression.;Change in gut microbiota composition in patients with celiac disease. Timepoint: Baseline and post-intervention (Week 8). Method of measurement: Measured ??????? stool sample analysis using 16S rRNA sequencing to assess microbiome composition and diversity.;Assessment of treatment-emergent adverse events related to saffron use. Timepoint: Throughout the study (Baseline, Week 4, Week 8, and as needed). Method of measurement: Assessed using Common Terminology Criteria for Adverse Events (CTCAE), including gastrointestinal, psychiatric, neurological, and immune system disorders.

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Secondary

Measure	Time frame
Changes in anxiety scores measured by the GAD-7 questionnaire. Timepoint: At baseline, week 4, and week 8. Method of measurement: Measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire; scores range from 0 to 21, with higher scores indicating greater anxiety.;Changes in depression scores measured by the PHQ-9 questionnaire. Timepoint: At baseline, week 4, and week 8. Method of measurement: Measured using the Patient Health Questionnaire-9 (PHQ-9); scores range from 0 to 27, with higher scores indicating greater depression severity.;Changes in gut microbiota composition (assessed using 16S rRNA sequencing of stool samples). Timepoint: At baseline and at the end of intervention (week 8). Method of measurement: Gut microbiota composition assessed using stool samples via 16S rRNA gene sequencing.;Safety and adverse effects of saffron. Timepoint: Throughout the study (baseline, week 4, and week 8). Method of measurement: Assessment of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE), including gastrointestinal, neurological, psychiatric, and immune-related events.	—

Measure

Time frame

Changes in anxiety scores measured by the GAD-7 questionnaire. Timepoint: At baseline, week 4, and week 8. Method of measurement: Measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire; scores range from 0 to 21, with higher scores indicating greater anxiety.;Changes in depression scores measured by the PHQ-9 questionnaire. Timepoint: At baseline, week 4, and week 8. Method of measurement: Measured using the Patient Health Questionnaire-9 (PHQ-9); scores range from 0 to 27, with higher scores indicating greater depression severity.;Changes in gut microbiota composition (assessed using 16S rRNA sequencing of stool samples). Timepoint: At baseline and at the end of intervention (week 8). Method of measurement: Gut microbiota composition assessed using stool samples via 16S rRNA gene sequencing.;Safety and adverse effects of saffron. Timepoint: Throughout the study (baseline, week 4, and week 8). Method of measurement: Assessment of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE), including gastrointestinal, neurological, psychiatric, and immune-related events.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRamin Niknam

Shiraz University of Medical Sciences

niknamramin@yahoo.com+98 71 3647 4334

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026