Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000741482
Ethics application status
Approved
Date submitted
1/06/2016
Date registered
6/06/2016
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Caralluma for Anxiety in Adults
Scientific title
A randomised placebo controlled clinical trial on the efficacy of Caralluma supplement for anxiety and stress in healthy adults over eight weeks
Secondary ID [1] 289349 0
Nil known
Universal Trial Number (UTN)
U1111-1183-7074
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 298975 0
Stress 298976 0
Condition category
Condition code
Mental Health 299041 299041 0 0
Anxiety
Alternative and Complementary Medicine 299042 299042 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Caralluma tablet group 1: 1 g/day active treatment group (500 mg morning and night) for 8 weeks.
Placebo group 2: Maltodextrin in a gelatin capsule (morning and night) for 8 weeks.

Adherence will be assessed by the investigator through phone calls and emails every 2 weeks. Assessment measures (BAI, PSS, PANAS, VAS, Cortisol) will be given before the intervention, at 4 weeks, and at the end of the intervention (8 weeks).
Intervention code [1] 294925 0
Treatment: Other
Comparator / control treatment
Placebo (maltodextrin in a gelatin capsule).
Control group
Placebo

Outcomes
Primary outcome [1] 298506 0
Change in mean Beck Anxiety Inventory score
Timepoint [1] 298506 0
Baseline, 4 weeks after intervention commenced, and 8 weeks after intervention commenced.
Primary outcome [2] 298507 0
Change in mean Perceived Stress Scale score
Timepoint [2] 298507 0
Baseline, 4 weeks after intervention commenced, and 8 weeks after intervention commenced.
Primary outcome [3] 298508 0
Change in morning cortisol reading (nmol/L) as measured by Healthscope Functional Pathology's Saliva Hormone Collection Kit; Baseline Hormone Profile (cortisol assay) (administered and tested by Clinical Laboratories, ABN 62 006 823 089).
Timepoint [3] 298508 0
Baseline, 4 weeks after intervention commenced, and 8 weeks after intervention commenced
Secondary outcome [1] 324415 0
Change in 100mm Visual Analog Scale for appetite
Timepoint [1] 324415 0
Baseline, 4 weeks after intervention commenced, and 8 weeks after intervention commenced

Eligibility
Key inclusion criteria
Participants will be included for assessment if they self-report mild-moderate anxiety (BAI >9<30), are not diagnosed with depression or a mood disorder, are otherwise healthy, and have given written informed consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they:
have a known hypersensitivity to herbal drugs, or nutritional supplements;
have been diagnosed with hypertension and are receiving medication;
have a medical condition which, in the opinion of the investigator, makes them unsuitable or deemed unhealthy (including a BMI > 30);
have currently or have a history of chronic alcohol and/or drug abuse;
have participated in any other clinical trial during last 30 days;
are currently participating in another clinical trial;
have been diagnosed with a mood disorder;
have minimal or severe anxiety on the Beck Anxiety Inventory (<10, or > 29);
suffered severe PMS with mood or pain that would change during the study;
suffered from any neurological disorder;
are taking supplements that impact mood or appetite (e.g., St John’s Wort, leptin);
are already taking Caralluma.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be allocated containers in numerical sequential order (e.g., the 5th participant recruited will receive container 5, with enough tablets for the length of the trial). The randomisation code will be maintained by the sponsor to keep the investigators blind to active treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Random Allocation Software version 1.0)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Change scores (delta) from baseline to week 4 and from baseline to week 8 will be calculated for each individual to reduce within-group variability. Group means of the change scores will be assessed using one-way independent ANOVA with Gabriel’s post-hoc comparison test, at p < .05. Correlation between appetite and anxiety and stress will be assessed using Pearson’s r.

A priori power analyses conducted using G*Power version 3.1.9.2 (Buchner, Erdfelder, Faul, & Lang, 2014) determined a sample size of 111 was required to attain a power of .80 for detecting a large effect size (assuming ANOVA is used to test for interaction effects; if simple one way ANOVA used to test the differences between means, only 52 participants are needed). This indicates that our proposed sample size (N = 120) is adequate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2016
Actual
3/10/2016
Date of last participant enrolment
Anticipated
1/03/2017
Actual
3/03/2017
Date of last data collection
Anticipated
Actual
12/05/2017
Sample size
Target
120
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 293728 0
Commercial sector/Industry
Name [1] 293728 0
RDC Global
Country [1] 293728 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RDC Global
Address
359 Merthyr Rd
New Farm
Queensland 4005
Australia
Country
Australia
Secondary sponsor category [1] 292560 0
None
Name [1] 292560 0
Address [1] 292560 0
Country [1] 292560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295162 0
Human Researh Ethics Committee of the Sunshine Coast
Ethics committee address [1] 295162 0
90 Sippy Downs Drive
Sippy Downs
Queensland 4556
Ethics committee country [1] 295162 0
Australia
Date submitted for ethics approval [1] 295162 0
04/07/2016
Approval date [1] 295162 0
05/08/2016
Ethics approval number [1] 295162 0

Summary
Brief summary
The aim of this study is to conduct a preliminary investigation of Caralluma supplement to examine its efficacy for reducing anxiety and stress in healthy adults over eight weeks. The study will assess 1 g/day compared to placebo. Satiety will also be measured to investigate any correlation between treatment effect for anxiety / stress and self-reported reduction in appetite.

It is hypothesised that a reduction in anxiety and stress (i.e., a decrease in negative anxiety scores ) over eight weeks would be significantly greater in the active treatment group than in the placebo group. Regarding Caralluma’s effect on satiety, it is hypothesised that a decrease in the VAS score would be significantly greater in the active treatment group than in the placebo group. It is also hypothesised that a decrease in the VAS score for appetite would be positively correlated with a decrease in the anxiety and stress scales.
Trial website
www.anxietytrial.com.au
Trial related presentations / publications
Public notes
Attachments [1] 1014 1014 0 0
/AnzctrAttachments/370824-Study Protocol . Clinical Trial . Anxiety.pdf (Protocol)
Attachments [2] 1015 1015 0 0
/AnzctrAttachments/370824-HREC Ethics Approval S16936 5AUG16.pdf (Ethics approval)

Contacts
Principal investigator
Name 66354 0
Mr Graham Kell
Address 66354 0
University of the Sunshine coast
90 Sippy Downs Drive
Sippy Downs
Queensland 4556
Country 66354 0
Australia
Phone 66354 0
+61412508777
Fax 66354 0
Email 66354 0
gbk001@student.usc.edu.au
Contact person for public queries
Name 66355 0
Mr Graham Kell
Address 66355 0
University of the Sunshine coast
90 Sippy Downs Drive
Sippy Downs
Queensland 4556
Country 66355 0
Australia
Phone 66355 0
+61412508777
Fax 66355 0
Email 66355 0
gbk001@student.usc.edu.au
Contact person for scientific queries
Name 66356 0
Prof Mary Katsikitis
Address 66356 0
University of the Sunshine coast
90 Sippy Downs Drive
Sippy Downs
Queensland 4556
Country 66356 0
Australia
Phone 66356 0
+61 7 54565034
Fax 66356 0
Email 66356 0
mkatsiki@usc.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics protocol designates that individual data will not be made public. All data is mean group data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised placebo controlled clinical trial on the efficacy of Caralluma fimbriata supplement for reducing anxiety and stress in healthy adults over eight weeks.2019https://dx.doi.org/10.1016/j.jad.2018.12.062
N.B. These documents automatically identified may not have been verified by the study sponsor.