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The effect of silymarin on some psychological and biological aspects of patients with generalized anxiety disorder

Investigating the effect of silymarin on changes in anxiety, plasma levels of cortisol, vitamin D, and thyroid hormones in patients with generalized anxiety disorder

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180201038585N13
Enrollment
34
Registered
2025-04-10
Start date
2025-02-18
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Generalized anxiety disorder. Generalized anxiety disorder

Interventions

Intervention 1: Intervention group: Participants in the treatment group will receive 200 mg of silymarin supplement (made by Goldaru Pharmaceutical Company) twice daily for 12 weeks. Intervention 2: C

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Participants must be between 18 and 65 years of age. Participants must have a diagnosis of generalized anxiety disorder (GAD) and depression. Participants must not be currently taking any medications for their condition. Participants must be able to provide Informed Consent Form. Participants must be willing to comply with the study protocol for the duration of the study. Participants must not have any known allergies or adverse reactions to silymarin. Participants must not have any significant medical conditions that may interfere with the results of the study. Participants must not be pregnant or breastfeeding. Participants must not have participated in any other clinical trial in the past three months. Participants must be able to attend all study visits and complete all study assessments.

Exclusion criteria

Exclusion criteria: Participants under 18 years of age or over 65 years of age. Participants without a diagnosis of generalized anxiety disorder (GAD) and depression. Participants currently taking medication for their condition. Participants unable to provide Informed Consent Form. Participants unwilling to comply with the study protocol for the duration of the study. Participants with known allergies or adverse reactions to silymarin. Participants with significant medical conditions that may interfere with the study results. Participants who are pregnant or breastfeeding. Participants who have participated in any other clinical trial in the past three months. Participants unable to attend all study visits and complete all study assessments.

Design outcomes

Primary

MeasureTime frame
Generalized anxiety. Timepoint: Before and 12 months after the intervention. Method of measurement: Beck Anxiety Inventory.

Secondary

MeasureTime frame
Plasma levels of the cortisol hormone. Timepoint: Before and 12 months after the intervention. Method of measurement: ELISA method and cortisol detection kit.;Plasma levels of vitamin D. Timepoint: Before and 12 months after the intervention. Method of measurement: HPLC.;Plasma levels of thyroid hormones. Timepoint: Before and 12 months after the intervention. Method of measurement: immunochemiluminometric assay (ICMA).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKarim Parastouei

Bagheiat-allah University of Medical Sciences

parastouei@bmsu.ac.ir+98 21 8755 5516

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026