Investigating the Impact of Griffonia simplicifolia and a Novel Proprietary Mushroom Blend on Mood and Sleep Quality in Young Adults.

Phase 2

• Registration Number: CTRI/2024/02/063100
• Lead Sponsor: RA USA LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Experiencing any of the following:

Feelings of unsettlement, nervousness and/or feeling tense;

Feelings of fatigue, weakness and/or tiredness;

Feelings of moodiness, irritability and/or restlessness;

Lack of concentration, racing thoughts, unwanted thoughts, fear and/or worry;

Difficulty concentrating;

Difficulty completing tasks and/or lack of motivation;

Feelings, thoughts and/or behaviours interfering with the ability to connect/bond with others;

Feelings of loneliness and/or withdrawal from social groups;

Preference of being alone;

Lack of interest in the activities or hobbies usually enjoyed;

Changes in sleeping patterns or habits;

Morning grogginess;

Daytime sleepiness;

Difficulty falling or staying asleep;

Waking up during the night;

Trouble focusing during daytime hours;

Participants willing to comply / perform study treatments including saliva sample collection and questionnaires;

Participants able to give written informed consent and willingness to participate in the study and comply with respective procedures.

Exclusion Criteria

Prospective participants that are trying to become pregnant, pregnant and or breastfeeding. Prospective participants taking anti depressant. Prospective participants taking monoamine oxidase inhibitors. Prospective participants taking central nervous system. Prospective participants using tobacco and alcohol abuse. Participants with previous history of serotonin syndrome. Participants with known allergy and or sensitivity to 5 Hydroxytryptrophan from Griffonia simplicifolia. Participants with a known allergy and or sensitivity to the following IP mushrooms. Participants with history of CVD, Participants with auto immune disorders, renal dysfunction, liver dysfunction, Type I & II diabetes, psychiatric disorders. Participants present or history of self harm sucidal thoughts and or ideations. Participants of eating disorder as per DSM 5. Participants with a history of sleep disorders including recurrent insomnia sleep wake disorders obstructive sleep apnea central sleep apnea sleep related hypoventilation parasomnia narcolepsy non rapid eye movement sleep arousal disorders rapid eye movement sleep behavior disorder hyperomnolence disorder nightmare disorder and or restless leg syndrome within the past five years. Any condition that the principal investigator deems precludes the participants ability to successfully and safely complete the study and or that may confound study outcomes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of mental health as assessed by the change in Depression, Anxiety and Stress Scales-21items (DASS-21) scores from baseline in comparison to placeboTimepoint: Day 0; Day 13; Day 25;

Secondary Outcome Measures

Name	Time	Method
As assessed by the change in salivary cortisolfrom baseline in comparison to placeboTimepoint: Day 0; Day 25;;Determine the efficacy and tolerability of the interventions by comparing them with a placebo.Timepoint: Day 0; Day 13; Day 25;