The Effectiveness of a Caralluma Fimbriata Extract on Stress, Sleep and Neurotransmitters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2023-05-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Caralluma fimbriata

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

Group Type EXPERIMENTAL

Caralluma Fimbriata

Intervention Type DRUG

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

Placebo comparator capsule - Microcrystalline cellulose

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

Group Type PLACEBO_COMPARATOR

Placebo comparator - Microcrystalline cellulose

Intervention Type DRUG

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

Interventions

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Caralluma Fimbriata

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

Intervention Type DRUG

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 Type DRUG

Other Intervention Names

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C.fimbriata

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes