Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT02800733
Status:
UNKNOWN
Last Update Posted:
2016-06-15
First Post:
2016-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-11', 'studyFirstSubmitDate': '2016-06-11', 'studyFirstSubmitQcDate': '2016-06-11', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton anxiety score', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Patients With Mild to Moderate GAD']}, 'descriptionModule': {'briefSummary': '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:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who diagnosed with GAD according to DSM-V criteria, Hamilton score of 18-25\n\nExclusion Criteria:\n\n* pregnancy and lactation\n* receiving antipsychotic medications in a month prior to the recruitment\n* suffered from other psychological disorders (e.g. bipolar disorder, schizophrenia, mood disorders), and drug abuse'}, 'identificationModule': {'nctId': 'NCT02800733', 'briefTitle': 'Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD)', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': 'The Effect of Saffron (Crocus Satious L.) in the Treatment of Mild to Moderate Generalized Anxiety Disorder: a Double Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '450/3654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'saffron', 'description': '450 mg of saffron capsule once a day for 6 weeks', 'interventionNames': ['Dietary Supplement: Saffron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo capsule once a day for 6 weeks', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Saffron', 'type': 'DIETARY_SUPPLEMENT', '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.', 'armGroupLabels': ['saffron']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '20 patients with mild to moderate GAD who receive sertraline will receive placebo too', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Soodeh Razeghi Jahromi, PhD', 'role': 'CONTACT', 'email': 'Razeghi@sina.tums.ac.ir', 'phone': '00989126229144'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Azita Hekmatdoost', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}