NCT02800733

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:

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

June 11, 2016

Last Update Submit

June 11, 2016

Conditions

Patients With Mild to Moderate GAD

Outcome Measures

Primary Outcomes (1)

  • Hamilton anxiety score

    6 weeks

Study Arms (2)

saffron

EXPERIMENTAL

450 mg of saffron capsule once a day for 6 weeks

Dietary Supplement: Saffron

placebo

PLACEBO COMPARATOR

placebo capsule once a day for 6 weeks

Dietary Supplement: placebo

Interventions

SaffronDIETARY_SUPPLEMENT

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.

saffron
placeboDIETARY_SUPPLEMENT

20 patients with mild to moderate GAD who receive sertraline will receive placebo too

placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who diagnosed with GAD according to DSM-V criteria, Hamilton score of 18-25

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Soodeh Razeghi Jahromi, PhD

CONTACT

00989126229144Razeghi@sina.tums.ac.ir

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Azita Hekmatdoost

Study Record Dates

First Submitted

June 11, 2016

First Posted

June 15, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

June 15, 2016

Record last verified: 2016-06