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

National Nutrition and Food Technology Institute

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Patients With Mild to Moderate GAD

Treatments: Dietary Supplement: Saffron; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02800733

450/3654

Details and patient eligibility

About

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:

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

saffron

Experimental group

Description:

450 mg of saffron capsule once a day for 6 weeks

Treatment:

Dietary Supplement: Saffron

placebo

Placebo Comparator group

Description:

placebo capsule once a day for 6 weeks

Treatment:

Dietary Supplement: placebo