StressPhase 2/3NCT05232266
The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters
A Phase 2/3 study testing Caralluma Fimbriata in people with Stress and Sleep, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
This is a double blind, randomised, placebo-controlled clinical trial aiming to assess the effectiveness of Caralluma fimbriata on stress, sleep and neurotransmitters in a healthy adult population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Caralluma Fimbriata
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Feb 2022to 19 May 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters, a Randomised Placebo-controlled Double-blind Study
This is a double blind, randomised, placebo-controlled clinical trial aiming to assess the effectiveness of Caralluma fimbriata on stress, sleep and neurotransmitters in a healthy adult population.
- Being tested
- Caralluma Fimbriata, Placebo comparator - Microcrystalline cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caralluma FimbriataDrug
Also called C.fimbriata
Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.
Placebo comparator - Microcrystalline celluloseDrug
Placebo comparator in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food.
| Study group | Role | What they receive |
|---|---|---|
| Caralluma fimbriata | Experimental | Caralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. Receives: Drug: Caralluma Fimbriata |
| Placebo comparator capsule - Microcrystalline cellulose | Placebo comparator | A comparator capsule taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. Receives: Drug: Placebo comparator - Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stress as assessed by Perceived Stress Scale (PSS)
Change in stress as assessed by Perceived Stress Scale (PSS) - Score range 0-40, Higher scores indicate higher perceived stress.
Measured: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress as assessed by Salivary Cortisol levels
Change in stress as assessed by Salivary Cortisol levels through assay
Measured: Baseline prior to commencement of study product, Week 4 and Week 8
Secondary outcomes (5)
Change in stress and mood as assessed by the Profile of Mood States (POMS) scale
Change in stress as assessed by Profile of Mood States (POMS) scale - Six dimensions including Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment assessed ona five point scale ranging from "not at all" to "extremely".
Measured: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress and mood as assessed by The Depression, Anxiety Stress Scale -21 (DASS-21)
Change in stress as assessed by DASS-21 - A set of three self-reported scales to measure emotional states of depression, anxiety and stress. Each scale contains 7 items.
Measured: Baseline prior to commencement of study product, Week 4 and Week 8
Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) which covers 7 domains with higher scores indicating poorer sleep quality.
Measured: Baseline prior to commencement of study product, Week 4 and Week 8
Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ)
Change in sleep as assessed by the Restorative Sleep Questionnaire (RSQ) which has 9 items scaled from 1-5. Higher total scores indicate a more restorative sleep.
Measured: Baseline prior to commencement of study product, Week 4 and Week 8
Change in Neurotransmitters as assessed by pathology
Change in neurotransmitters Serotonin, Dopamine, oxytocin, nor-epinephrine, adrenalin, glutamate and GABA as assessed by pathology
Measured: Baseline prior to commencement of study product, Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start10 Feb 2022
- Primary completion19 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Rao, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232266
- Sponsor's protocol ID
- CARSTA-21
- Status last verified
- Oct 2023
- First submitted
- 18 Jan 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters, a Randomised Placebo-controlled Double-blind Study
- ClinicalTrials.gov ID
- NCT05232266
- Acronym / sponsor ID
- CARSTA-21
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blind, randomised, placebo-controlled clinical trial aiming to assess the effectiveness of Caralluma fimbriata on stress, sleep and neurotransmitters in a healthy adult population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caralluma fimbriata | Experimental | Drug: Caralluma FimbriataCaralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. |
| Placebo comparator capsule - Microcrystalline cellulose | Placebo comparator | Drug: Placebo comparator - Microcrystalline celluloseA comparator capsule taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caralluma FimbriataAlso: C.fimbriataCaralluma fimbriata in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. | Drug | Caralluma fimbriata |
| Placebo comparator - Microcrystalline cellulosePlacebo comparator in capsule form - taken as a 500mg dose (two 250mg capsules) twice daily, morning and evening with food. | Drug | Placebo comparator capsule - Microcrystalline cellulose |
Primary outcome
Change in stress as assessed by Perceived Stress Scale (PSS)
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress as assessed by Perceived Stress Scale (PSS) - Score range 0-40, Higher scores indicate higher perceived stress.
Change in stress as assessed by Salivary Cortisol levels
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress as assessed by Salivary Cortisol levels through assay
5 secondary outcomes
Change in stress and mood as assessed by the Profile of Mood States (POMS) scale
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in stress and mood as assessed by The Depression, Anxiety Stress Scale -21 (DASS-21)
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in sleep as measured by the Restorative Sleep Questionnaire (RSQ)
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Change in Neurotransmitters as assessed by pathology
Time frame: Baseline prior to commencement of study product, Week 4 and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Rao, PhD principal investigator
RDC Clinical Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Caralluma Fimbriata in people with Stress and Sleep, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stress as assessed by Perceived Stress Scale (PSS) (time frame: Baseline prior to commencement of study product, Week 4 and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.