Patients With Mild to Moderate GAD
Conditions
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:
Interventions
DIETARY_SUPPLEMENTSaffron
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.
DIETARY_SUPPLEMENTplacebo
20 patients with mild to moderate GAD who receive sertraline will receive placebo too
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton anxiety score | 6 weeks |
Contacts
Primary ContactSoodeh Razeghi Jahromi, PhD
Outcome results
None listed