An investigation of the psychological, somatic and related social effects resulting from the use of American skullcap (Scutellaria lateriflora): a randomised placebo-controlled crossover study in healthy volunteers

niversity of Westminster (UK)0 sites42 target enrollmentSeptember 4, 2009

Overview

No summary available.

Registry

who.int

Start Date

September 4, 2009

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Westminster (UK)

•Current inclusion criteria as of 24/03/2011:
•1\. Aged 18 \- 75 years, either sex
•2\. Good general health
•3\. Males and females
•4\. Participants will be volunteers and will have given informed consent
•5\. Agree to undergo a fingerprick blood test for analysis of liver function pre\-, intermediate\- and post\-intervention
•Previous inclusion criteria:
•1\. Symptoms of moderate anxiety, indicated by a cut\-off score point for anxiety on the Beck Anxiety Inventory (BAI) between 16 \- 25
•2\. Aged 18 \- 75 years, either sex
•3\. Good general health

•Current exclusion criteria as of 24/03/2011:
•1\. Alcohol, tobacco or recreational drug dependence
•2\. Known hypersensitivity to any herbal medicines when taken orally
•3\. Current use or use within the past month of antipsychotic medication, e.g., tranquilisers, antidepressants, or sedatives
•4\. A history of (diagnosed) severe psychiatric disorders, e.g., clinical depression, bipolar disorder or generalised anxiety disorder
•5\. Neurological, immunological or endocrinological disorders
•6\. Liver disease, kidney disease, cancer, diabetes mellitus, malignant hypertension or any other serious medical condition
•7\. Moderate\-high depression, i.e., Hospital Anxiety and Depression Scale (HADS) scores 8 \- 21
•8\. Those currently on, or with a recent history of using, synthetic hormones (other than the contraceptive pill), including sprays or topical corticosteroid analogues
•9\. Those taking herbs or supplements that many have either a direct or indirect effect on the HPA axis (e.g., dopaminergic, serotonergic, gamma\-aminobutyric acid \[GABA] \-ergic)