ISRCTN48078312CompletedNot Applicable
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 enrollmentStarted: September 4, 2009Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •4. Males and females
- •5. Participants will be volunteers and will have given informed consent
- •6. Agree to undergo a fingerprick blood test for analysis of liver function pre-, intermediate- and post-intervention
Exclusion Criteria
- •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)
- •10. Pregnancy or lactation
- •11. Those under 18 or over 75
- •12. Refusal to undergo blood tests
- •Previous exclusion criteria:
- •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. Initial scores of above 26 in the BAI, indicating severe anxiety
- •9. Initial scores below 16 in the BAI, indicating mild anxiety
- •10. Those currently on, or with a recent history of using, synthetic hormones (other than the contraceptive pill), including sprays or topical corticosteroid analogues
- •11. 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)
- •12. Pregnancy or lactation
- •13. Those under 18 or over 75
- •14. Refusal to undergo blood tests
Investigators
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