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

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ClinicalTrials.gov Identifier: NCT02800733
Recruitment Status : Unknown
Verified June 2016 by Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Hamilton anxiety score [ Time Frame: 6 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800733


Contacts
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Contact: Soodeh Razeghi Jahromi, PhD 00989126229144 Razeghi@sina.tums.ac.ir

Sponsors and Collaborators
National Nutrition and Food Technology Institute
More Information
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Responsible Party: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02800733    
Other Study ID Numbers: 450/3654
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders