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CTRI Number  CTRI/2024/02/063100 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Investigating the Impact of Griffonia simplicifolia and a Novel Proprietary Mushroom Blend on Mood and Sleep Quality in Young Adults. 
Scientific Title of Study   A 3-arm Randomised, double-blind, placebo-controlled Study Comparing Griffonia simplicifolia and a Novel Propriety Mushroom Blend on Mood and Sleep Quality Enhancement in Young Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BSP-23-058 [Version No.3.0 ;Dated 17-Jan-2024]  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Santosh Ramdurg 
Designation  Professor and HOD of Psychiatry 
Affiliation  Shri. B. M. Patil Medical College, Hospital & Research Centre 
Address  Room No. 2, 3rd Floor, Department of Psychiatry Shri. B. M. Patil Medical College, Hospital & Research Centre, Bangaramma Sajjan Campus, Solapur Road, Vijayapura-586103, Karnataka State, India

Bijapur
KARNATAKA
586103
India 
Phone  9611281386   
Fax  918352263019  
Email  santosh.ramdurg@bldedu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Divya Chandradhara 
Designation  CEO 
Affiliation  Bioagile Therapeutics Pvt. Ltd. 
Address  #2/5, Dahlia Building, 3rd Floor, 80 Feet Road RMV 2nd Stage, Bengaluru 560094, India

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya Chandradhara 
Designation  CEO 
Affiliation  Bioagile Therapeutics Pvt. Ltd. 
Address  #2/5, Dahlia Building, 3rd Floor, 80 Feet Road RMV 2nd Stage, Bengaluru 560094, India


KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
NURA USA LLC; 16912 Von Karman Ave, Unit B, Irvine, CA 92606 USA  
 
Primary Sponsor  
Name  NURA USA LLC 
Address  16912 Von Karman Ave, Unit B, Irvine, CA 92606 USA  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravikishore Sadula  Induss Hospital Telangana  13-23-1-93/1, Block-1, Room No. 2, G.Floor, Department of Psychiatry, Induss Hospital, Krishnaveni Nagar, Gaddiannaram, Near Municipal Office, Saroornagar, Telengana, India
Hyderabad
TELANGANA 		 7799933313

ravikishore959@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Induss Hospital  Approved 
Shri B.M. Patil Medical College, Hospital and Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young adult males and females aged 18-32 years with unsettled feelings, moodiness, difficulty concentrating, and changes in sleep patterns. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ADAPTGUARD-proprietary mushroom blend.(Capsules and Chewable bars)  Twice a day for 25 days 
Intervention  CLEANMOOD-extract of Griffonia simplicifolia.(Capsules and Chewable bars)  Twice a day for 25 days  
Comparator Agent  Placebo (Capsules and Chewable bars)  Twice a day for 25 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  32.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Efficacy of mental health as assessed by the change in Depression, Anxiety and Stress Scales-21 items (DASS-21) scores from baseline in comparison to placebo  Day 0; Day 13; Day 25; 
 
Secondary Outcome  
Outcome  TimePoints 
As assessed by the change in salivary cortisol from baseline in comparison to placebo  Day 0; Day 25; 
Determine the efficacy and tolerability of the interventions by comparing them with a placebo.  Day 0; Day 13; Day 25; 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   26/02/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
In this randomized, double-blind, placebo-controlled study titled "A 3-arm Randomised, double-blind, placebo-controlled Study Comparing Griffonia simplicifolia and a Novel Proprietary Mushroom Blend on Mood and Sleep Quality Enhancement in Young Adults," the primary efficacy outcome revolves around assessing mental health using the Depression, Anxiety, and Stress Scales-21 items (DASS-21). The study aims to compare the change in DASS-21 scores from baseline to placebo, evaluating the efficacy and tolerability of nutritional supplementation with standardized preparations of Griffonia simplicifolia and a novel proprietary mushroom blend. Secondary efficacy outcomes include the evaluation of mood and sleep duration through salivary cortisol levels. Tertiary efficacy outcomes focus on comparing the effects of capsule preparations versus chewable snack bar applications. Safety outcomes encompass the recording of adverse events, drop-outs, compliance rates, and safety parameters such as vital signs and laboratory tests. The study aims to provide a comprehensive understanding of the impact of Griffonia simplicifolia and the novel proprietary mushroom blend on mental health, sleep, and overall well-being in young adults, while ensuring safety through rigorous monitoring and comparisons across groups.
 
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