The Efficacy of Caralluma for Anxiety in Adults

A randomised placebo controlled clinical trial on the efficacy of Caralluma supplement for anxiety and stress in healthy adults over eight weeks

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000741482

Enrollment

117

Registered

2016-06-06

Start date

2016-10-03

Completion date

2017-03-03

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to conduct a preliminary investigation of Caralluma supplement to examine its efficacy for reducing anxiety and stress in healthy adults over eight weeks. The study will assess 1 g/day compared to placebo. Satiety will also be measured to investigate any correlation between treatment effect for anxiety / stress and self-reported reduction in appetite. It is hypothesised that a reduction in anxiety and stress (i.e., a decrease in negative anxiety scores ) over eight weeks would be significantly greater in the active treatment group than in the placebo group. Regarding Caralluma’s effect on satiety, it is hypothesised that a decrease in the VAS score would be significantly greater in the active treatment group than in the placebo group. It is also hypothesised that a decrease in the VAS score for appetite would be positively correlated with a decrease in the anxiety and stress scales.

Interventions

Caralluma tablet group 1: 1 g/day active treatment group (500 mg morning and night) for 8 weeks. Placebo group 2: Maltodextrin in a gelatin capsule (morning and night) for 8 weeks. Adherence will be assessed by the investigator through phone calls and emails every 2 weeks. Assessment measures (BAI, PSS, PANAS, VAS, Cortisol) will be given before the intervention, at 4 weeks, and at the end of the intervention (8 weeks).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

Participants will be included for assessment if they self-report mild-moderate anxiety (BAI >9<30), are not diagnosed with depression or a mood disorder, are otherwise healthy, and have given written informed consent.

Exclusion criteria

Participants will be excluded if they: have a known hypersensitivity to herbal drugs, or nutritional supplements; have been diagnosed with hypertension and are receiving medication; have a medical condition which, in the opinion of the investigator, makes them unsuitable or deemed unhealthy (including a BMI > 30); have currently or have a history of chronic alcohol and/or drug abuse; have participated in any other clinical trial during last 30 days; are currently participating in another clinical trial; have been diagnosed with a mood disorder; have minimal or severe anxiety on the Beck Anxiety Inventory (<10, or > 29); suffered severe PMS with mood or pain that would change during the study; suffered from any neurological disorder; are taking supplements that impact mood or appetite (e.g., St John’s Wort, leptin); are already taking Caralluma.

Outcome results