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

• Sponsor: National Nutrition and Food Technology Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02800733
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

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:

Condition or Disease	Intervention/Treatment	Phase
Patients With Mild to Moderate GAD	Dietary Supplement: Saffron; Dietary Supplement: placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2016
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: saffron 450 mg of saffron capsule once a day for 6 weeks	Dietary Supplement: Saffron; 20 patients with mild to moderate GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders-IѴ (DSM-IѴ) 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 Comparator: placebo placebo capsule once a day for 6 weeks	Dietary Supplement: placebo; 20 patients with mild to moderate GAD who receive sertraline will receive placebo too

Outcome Measures

Primary Outcome Measures

1. Hamilton anxiety score [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Azita Hekmatdoost, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
• ClinicalTrials.gov Identifier: NCT02800733
• Other Study ID Numbers: 450/3654
• First Posted: Jun 15, 2016
• Last Update Posted: Jun 15, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Jun 15, 2016