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Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Primary Purpose

Depression, Anxiety

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Nepeta menthoides Boiss & Bohse freeze dried extract

Sertraline

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

having depression according to Persian-language version of the Beck Depression Inventory-Second edition
get score above 7 according to Persian version of Beck Anxiety Inventory (BAI)

Exclusion Criteria:

pregnancy and lactation
allergy to N. menthoides and Lamiaceae family
patients with suicidal thoughts or previous suicidal attempt
patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism
patients who used substances or alcohol
patients who had indication for electroconvulsive therapy -

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Nepeta menthoides Boiss & Bohse freeze dried extract capsule

Sertraline capsule

Arm Description

Outcomes

Primary Outcome Measures

Persian version of Beck Anxiety Inventory (BAI)

Secondary Outcome Measures

side effects of intervention drugs

Full Information

NCT ID

NCT02565316

First Posted

September 29, 2015

Last Updated

September 30, 2015

Sponsor

Shiraz University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02565316

Brief Title

Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Official Title

Efficacy of Nepeta Menthoides Boiss & Bohse Freeze Dried Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study is to assess the efficacy of Nepeta menthoides as an anti anxiety herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial. A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz medical university, who having depression according to Persian-language version of the Beck Depression Inventory-Second edition and get score above 11 according to Persian version of Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and 1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation, allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism and patients who used substances or alcohol and patients who had indication for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd week, 4th week and then two weeks after the end of the intervention (in 6th week)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nepeta menthoides Boiss & Bohse freeze dried extract capsule

Arm Type

Active Comparator

Arm Title

Sertraline capsule

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Nepeta menthoides Boiss & Bohse freeze dried extract

Intervention Type

Drug

Intervention Name(s)

Sertraline

Primary Outcome Measure Information:

Title

Persian version of Beck Anxiety Inventory (BAI)

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

side effects of intervention drugs

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: having depression according to Persian-language version of the Beck Depression Inventory-Second edition get score above 7 according to Persian version of Beck Anxiety Inventory (BAI) Exclusion Criteria: pregnancy and lactation allergy to N. menthoides and Lamiaceae family patients with suicidal thoughts or previous suicidal attempt patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism patients who used substances or alcohol patients who had indication for electroconvulsive therapy -

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

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