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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05232266




Registration number
NCT05232266
Ethics application status
Date submitted
18/01/2022
Date registered
9/02/2022

Titles & IDs
Public title
The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters
Scientific title
The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters, a Randomised Placebo-controlled Double-blind Study
Secondary ID [1] 0 0
CARSTA-21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 0 0
Sleep 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Caralluma Fimbriata
Treatment: Drugs - Placebo comparator - Microcrystalline cellulose

Experimental: Caralluma fimbriata - Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.

Placebo comparator: Placebo comparator capsule - Microcrystalline cellulose - A comparator capsule taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.


Treatment: Drugs: Caralluma Fimbriata
Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.

Treatment: Drugs: Placebo comparator - Microcrystalline cellulose
Placebo comparator in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in stress as assessed by Perceived Stress Scale (PSS)
Timepoint [1] 0 0
Baseline prior to commencement of study product, Week 4 and Week 8
Primary outcome [2] 0 0
Change in stress as assessed by Salivary Cortisol levels
Timepoint [2] 0 0
Baseline prior to commencement of study product, Week 4 and Week 8
Secondary outcome [1] 0 0
Change in stress and mood as assessed by the Profile of Mood States (POMS) scale
Timepoint [1] 0 0
Baseline prior to commencement of study product, Week 4 and Week 8
Secondary outcome [2] 0 0
Change in stress and mood as assessed by The Depression, Anxiety Stress Scale -21 (DASS-21)
Timepoint [2] 0 0
Baseline prior to commencement of study product, Week 4 and Week 8
Secondary outcome [3] 0 0
Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 0 0
Baseline prior to commencement of study product, Week 4 and Week 8
Secondary outcome [4] 0 0
Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ)
Timepoint [4] 0 0
Baseline prior to commencement of study product, Week 4 and Week 8
Secondary outcome [5] 0 0
Change in Neurotransmitters as assessed by pathology
Timepoint [5] 0 0
Baseline prior to commencement of study product, Week 4 and Week 8

Eligibility
Key inclusion criteria
* Adults aged 18 years and above
* Self-reporting Stress
* Able to provide informed consent
* Agree not to change current diet and exercise program while enrolled in this trial
* Agree not to undertake another clinical trial while enrolled in this trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, diabetes, thyroid gland dysfunction)*
* Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
* Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
* Receiving treatment for anxiety, or taking supplements# for anxiety or sleep conditions such as saffron, valerian, etc.
* Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (>14 alcoholic drinks week)
* Allergic to any of the ingredients in the active or placebo formula
* Known pregnant or lactating woman
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participants who have participated in any other related clinical study during the past 1 month
* History of infection in the month prior to the study

* An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

* Potential participants that are taking supplements that would result in their exclusion must wait a 4-week washout period prior to commencing the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/05/2023
Sample size
Target
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Newstead
Recruitment postcode(s) [1] 0 0
4006 - Newstead

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05232266