American skullcap (Scutellaria lateriflora): a study of its effects on mood in healthy volunteers

ISRCTN	ISRCTN48078312
DOI	https://doi.org/10.1186/ISRCTN48078312
Protocol serial number	UW080921
Sponsor	University of Westminster (UK)
Funder	University of Westminster (UK) - Institute of Health and Wellbeing

Submission date: 01/07/2009
Registration date: 04/09/2009
Last edited: 10/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Christine Brock
Scientific

University of Westminster
115 New Cavendish Street
London
W1W 6UW
United Kingdom

Phone	+44 (0)20 7911 5000
Email	C.Brock@westminster.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional randomised double-blind (subjects, investigators/outcome assessors) placebo-controlled crossover study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	Anxiety is a common but potentially serious disorder as it can lead to both somatic and social dysfunction. Orthodox anxiolytics are associated with unpleasant side-effects and dependency. There is therefore an urgent need for safe, well-tolerated and effective alternatives. American skullcap (Scutellaria lateriflora) is a popular herb in traditional medicine systems and the western herbal medicine Materia medica is used for anxiety, stress, hysteria, tremors, sleep disorders, panic, tension, and related disorders. It is reported to have minimal side-effects and no known toxicity. It is therefore an ideal candidate for providing evidence for its efficacy and safety with a view to its widespread use as a licensed product, for the reduction of anxiety, stress and related co-morbidities. Research question: Can Scutellaria lateriflora extracts provide an effective treatment for reducing anxiety and stress? Study hypotheses: 1. S. lateriflora will have a superior anxiolytic effect to placebo 2. The safety profile of S. lateriflora will be comparable to that of placebo 3. S. lateriflora will reduce anxiety without a marked diminution of cognition or energy 4. S. lateriflora will decrease salivary cortisol levels in moderately anxious individuals On 07/09/2009 this record was updated to include a new anticipated start date; the initial start date at the time of registration was 01/09/2009. On 24/03/2011 this record was updated to include an edited public title, scientific title, inclusion criteria, exclusion criteria, anticipated start and end dates and status of trial. Previous public title: American skullcap (Scutellaria lateriflora) for anxiety and stress: an efficacy study in healthy volunteers Previous scientific title: An investigation of the psychological, somatic and related social effects resulting from the use of American skullcap (Scutellaria lateriflora) in the treatment of anxiety and stress: a randomised placebo-controlled crossover study in healthy volunteers with self-reported moderate anxiety The previous start date was 01/11/2009 and the previous end date was 01/12/2010.
Ethics approval(s)	University of Westminster Research Ethics Sub-Committee, 24/4/2009, ref: 08/09/21
Health condition(s) or problem(s) studied	Moderate anxiety
Intervention	Intervention: organic freeze-dried Scutellaria lateriflora capsules 350 mg three times daily Placebo control: organic freeze-dried stinging nettle leaf (Urtica dioica folia) capsules 300 mg three times daily The study will last for 38 days including a 7-day washout period. Participants will be randomly assigned to receive either freeze-dried Scutellaria lateriflora test or freeze-dried Urtica dioica folia placebo three times daily for half of the intervention study duration and then, following a washout period of 1 week, will cross over to receive the other for comparison. In other words, participants will be acting as their own controls. Clinical reporting scales and salivary cortisol measurements will be used to compare anxiety symptoms and quality of life at the beginning, before the end of the first half prior to crossover, and at the end of the clinical study. There have been no reports of toxicity associated with S. lateriflora. To confirm its safety profile, all participants will undergo fingerpick blood extraction for liver function analysis pre-, intermediate and post-intervention.
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Scutellaria lateriflora, Urtica dioica folia
Primary outcome measure(s)	Reduction in anxiety following 2 weeks' intervention in comparison to placebo control, indicated by a significantly reduced score on the Beck Anxiety Inventory, projected to be at least 10 points (0 - 7 = no anxiety-minimal anxiety; 8 - 15 = mild anxiety; 16 - 25 = moderate anxiety; 26 - 63 = severe anxiety).
Key secondary outcome measure(s)	1. Self-reported changes in quality of life 2. Changes in salivary cortisol measurements to indicate a reduction in stress levels 3. Live blood analysis of liver function by fingerprick blood extraction Sampling and testing for secondary outcome measures will be conducted prior to commencement of the interventional stage of the study in order to take baseline measurements for comparison with subsequent measurements, during the last 2 days of the first half of the intervention prior to a 7-day washout period and during the last 2 days of the second half of the intervention study following crossover. Pulse and blood pressure will also be assessed at these time-points as a matter of interest.
Completion date	30/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	42
Key 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
Key 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
Date of first enrolment	01/04/2011
Date of final enrolment	30/10/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Westminster

London
W1W 6UW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes