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

Primary Purpose

Patients With Mild to Moderate GAD

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Saffron
placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Mild to Moderate GAD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    saffron

    placebo

    Arm Description

    450 mg of saffron capsule once a day for 6 weeks

    placebo capsule once a day for 6 weeks

    Outcomes

    Primary Outcome Measures

    Hamilton anxiety score

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2016
    Last Updated
    June 11, 2016
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02800733
    Brief Title
    Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Nutrition and Food Technology Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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:

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patients With Mild to Moderate GAD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    saffron
    Arm Type
    Experimental
    Arm Description
    450 mg of saffron capsule once a day for 6 weeks
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo capsule once a day for 6 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Saffron
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    20 patients with mild to moderate GAD who receive sertraline will receive placebo too
    Primary Outcome Measure Information:
    Title
    Hamilton anxiety score
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Soodeh Razeghi Jahromi, PhD
    Phone
    00989126229144
    Email
    Razeghi@sina.tums.ac.ir

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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