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

RDC Clinical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sleep; Stress

Treatments: Drug: Placebo comparator - Microcrystalline cellulose; Drug: Caralluma Fimbriata

Study type: Interventional

Funder types: Industry

Identifiers

NCT05232266

CARSTA-21

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 2 patient groups, including a placebo group

Caralluma fimbriata

Experimental group

Description:

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

Treatment:

Drug: Caralluma Fimbriata

Placebo comparator capsule - Microcrystalline cellulose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo comparator - Microcrystalline cellulose