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

NCT ID: NCT02800733

Last Updated: 2016-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients With Mild to Moderate GAD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

saffron

450 mg of saffron capsule once a day for 6 weeks

Group Type EXPERIMENTAL

Saffron

Intervention Type DIETARY_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.

placebo

placebo capsule once a day for 6 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Azita Hekmatdoost

Dr Azita Hekmatdoost

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Soodeh Razeghi Jahromi, PhD

Role: CONTACT

00989126229144

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

450/3654

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Natural Heart Health Supplement Trial
NCT06671769 NOT_YET_RECRUITING PHASE1