Anxiety symptoms
Conditions
Interventions
Group 1: Aloysia polystachya - powdered plant material in capsules, oral daily dose of 600 mg/day, for 8 weeks. Total of 25 patients.
Group 2: Placebo - identical capsules containing maltodextrin. Tot
Drug
E02.190.755
Sponsors
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
Universidade de Ribeirão Preto
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 60 years; HAM-A score of at least 18 points; No history of allergy to A. polystachya or its components or to plants from Verbenaceae family; No use of psychotropic drugs; Not in psychiatric treatment; Not have used psychotropic medicines within 2 weeks; Not be smoker; Not be heavy drinker.
Exclusion criteria
Exclusion criteria: Patient's request; Allergy or adverse reaction attributable to the plant; Any alcohol use within 1 week or during study; Any psychotropic drug use within 1 week or during study; Any psychiatric treatment within 1 week or during study; Smoking within 1 week or during study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected: Reduction of , difference between anxiety intensity , after 8 weeks , of at least 8 points , assessed by the method proposed by HAMILTON, 1959.;Expected: Reduction of , difference between anxiety intensity divided by baseline , after 8 weeks , of at least 30 percentual points , assessed by the method proposed by HAMILTON, 1959. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected: Reduction of , difference between anxiety intensity , after 8 weeks , of at least 8 points , assessed by visual analog scale.;Observed: Non significant reduction of , difference between the logarithm of anxiety intensity , after 8 weeks , of 0.24 (95%CI -0.14, 0.61) , assessed by visual analog scale. | — |
Countries
Brazil
Contacts
Public ContactFabio Carmona
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
Outcome results
None listed