Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD)

Phase 2

• Conditions: Patients With Mild to Moderate GAD
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Saffron

• Registration Number: NCT02800733
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

anxiety disorder is one of the major public health problems worldwide. 25% of people experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as the most prevalent anxiety disorder. Saffron has previously approved as an effective adjuvant therapy in depression and might alleviate GAD symptoms.Since up to the best of our knowledge no human studies have assessed the therapeutic effect of saffron as an adjuvant therapy in GAD patients, Therefore, this study is planned to evaluateThe effect of saffron (Crocus satious L.) in the treatment of mild to moderate generalized anxiety disorder:

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-11
• Study First Submitted QC: 2016-06-11
• Last Update Submitted: 2016-06-11
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15
• Primary Completion: 2016-08
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients who diagnosed with GAD according to DSM-V criteria, Hamilton score of 18-25

Exclusion Criteria

• pregnancy and lactation
• receiving antipsychotic medications in a month prior to the recruitment
• suffered from other psychological disorders (e.g. bipolar disorder, schizophrenia, mood disorders), and drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo capsule once a day for 6 weeks
saffron	Saffron	450 mg of saffron capsule once a day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Hamilton anxiety score	6 weeks