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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05518019
Other study ID # 20236
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2022
Est. completion date June 29, 2022

Study information

Verified date August 2022
Source Prima CBD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A high-quality broad-spectrum cannabidiol supplement with a bio-terpene complex will be administered once daily. It is hypothesized that this supplement will lead to improvements in sleep, focus, and stress. Previous research supports that CBD supplementation provides support to the endocannabinoid system, allowing the brain to better control negative psychological outcomes like fear, stress, and negative mood states.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 29, 2022
Est. primary completion date June 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Provision of signed and dated informed consent form - Stated willingness to comply with all study procedures and availability for the duration of the study - Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsules per day). - Must be in general good health (e.g., no long term health issues that would impact your participation. - Moderate self-reported issues with stress, mood, focus, and sleep. Exclusion Criteria: - Current use of selective serotonin reuptake inhibitors or prescription medication for the treatment of depression or anxiety and have not been on a stable dose for more than 60 days. - Currently receiving other psychotherapeutic treatment for anxiety or depression. - Diagnosed anxiety or depression - BMI over 40 - Known allergic reactions that would require the use of an epi-pen - Females who are pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
The Daily Supplement
Each serving of the dietary supplement (defined as 1 softgel) contains the following formulation: Organic Broad Spectrum Hemp Extract 35mg Bio-Terpene Complex 52mg Palm Monoglycerides Organic Hemp Seed Oil, Clove Bud Oil, Black Pepper Berry Essential Oil Curcumin (Turmeric Root) Essential Oil Inactive ingredients: Organic Flaxseed Oil, Gel Shell (Modified Tapioca Starch, Glycerin, Purified Water, Maltitol

Locations

Country Name City State
United States Citruslabs Santa Monica California

Sponsors (2)

Lead Sponsor Collaborator
Prima CBD Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in overall well-being as measured by self-report and questionnaires. Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe") 2 months
Primary Change in stress and anxiety as measured by questionnaires. Feeling states that will be measured include stress, calmness, balance, relaxation, and focus
Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")
2 months
Primary Change in mood as measured by questionnaire Feeling states that will be measured include stress, calmness, balance, relaxation, and focus
Each endpoint will be reported by the participant on a 7-point scale of perceived frequency and severity of feeling states (Ranging from "Never" to "Everyday", and "None" to "Very severe")
2 months
Secondary Change in sleep quality and quantity as measured by digital wearable devices and by self-report Sleep will be measured two ways. Questionnaires will be used to assess sleep quality and quantity.
Participants will also use wearable devices to track their sleep over the course of the study.
2 months
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