Condition category
Mental and Behavioural Disorders
Date applied
01/07/2009
Date assigned
04/09/2009
Last edited
10/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Christine Brock

ORCID ID

Contact details

University of Westminster
115 New Cavendish Street
London
W1W 6UW
United Kingdom
+44 (0)20 7911 5000
C.Brock@westminster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UW080921

Study information

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

Acronym

Study hypothesis

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

University of Westminster Research Ethics Sub-Committee, 24/4/2009, ref: 08/09/21

Study design

Interventional randomised double-blind (subjects, investigators/outcome assessors) placebo-controlled crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

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 names

Scutellaria lateriflora, Urtica dioica folia

Primary outcome measures

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).

Secondary outcome measures

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.

Overall trial start date

01/04/2011

Overall trial end date

30/10/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant 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

Recruitment start date

01/04/2011

Recruitment end date

30/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Westminster
London
W1W 6UW
United Kingdom

Sponsor information

Organisation

University of Westminster (UK)

Sponsor details

c/o Mrs Carole Mainstone
309 Regent Street
London
W1B 2UW
United Kingdom

Sponsor type

University/education

Website

http://www.wmin.ac.uk

Funders

Funder type

University/education

Funder name

University of Westminster (UK) - Institute of Health and Wellbeing

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23878109

Publication citations

  1. Results

    Brock C, Whitehouse J, Tewfik I, Towell T, American Skullcap (Scutellaria lateriflora): a randomised, double-blind placebo-controlled crossover study of its effects on mood in healthy volunteers., Phytother Res, 2014, 28, 5, 692-698, doi: 10.1002/ptr.5044.

Additional files

Editorial Notes