Status:
COMPLETED
The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters
Lead Sponsor:
RDC Clinical Pty Ltd
Conditions:
Stress
Sleep
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2023
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT05232266
Start Date
February 10 2022
End Date
May 19 2023
Last Update
October 24 2023
Active Locations (1)
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1
RDC Clinical Pty Ltd
Newstead, Queensland, Australia, 4006