NCT Number: NCT02565316
Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial
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)
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Notify MeKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 -
Treatment and study plan
Sertraline
DrugPrimary outcomes
-
Persian version of Beck Anxiety Inventory (BAI)
Time frame: 6 weeks
Secondary outcomes
-
side effects of intervention drugs
Time frame: 6 weeks
Sponsors and collaborators
Lead sponsor
Shiraz University of Medical Sciences
Other
Registry information
Official study title
Efficacy of Nepeta Menthoides Boiss & Bohse Freeze Dried Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Oct 1, 2015
- Registry last updated
- Oct 1, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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