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

Patients With Mild to Moderate GAD Clinical Trial

Official title:

The Effect of Saffron (Crocus Satious L.) in the Treatment of Mild to Moderate Generalized Anxiety Disorder: a Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02800733
• Other study ID #: 450/3654
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: June 11, 2016
• Last updated: June 11, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: National Nutrition and Food Technology Institute
• Contact: Soodeh Razeghi Jahromi, PhD
• Phone: 00989126229144
• Email: Razeghi[@]sina.tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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:

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Patients With Mild to Moderate GAD

Intervention

Dietary Supplement:
• Saffron
20 patients with mild to moderate GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders-I? (DSM-I?) who receive sertraline will randomly receive saffron (450 mg) as an add-on therapy on daily bases for 6 weeks. Hamilton Anxiety Rating Scale (HAM-A) will use to assess the effect of treatment.
• placebo
20 patients with mild to moderate GAD who receive sertraline will receive placebo too

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton anxiety score		6 weeks	No