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CTRI Number  CTRI/2025/02/081075 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of Focus Elixir Drink for energy and Mood Enhancement in Adults. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Focus Elixir Drink in enhancing focus, cognitive function, energy levels, and mood regulation in adults. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/042 Ver.:1.00 Dated 23/10/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre 
Address  Fourth-floor OPD 401-314 B Telco ROAD Chinchwad.

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ritesh Mathur 
Designation  Director 
Affiliation  f2f food and beverages 
Address  215, Jogeshwari East, Mumbai.

Mumbai
MAHARASHTRA
400060
India 
Phone  9769458055  
Fax  -  
Email  ritesh.mathur@f2fconsultants.com  
 
Details of Contact Person
Public Query  
Name  Yash Shukla 
Designation  Director 
Affiliation  Weather Woods Pvt. Ltd 
Address  A-41 second Floor, NDSE Part II, South Delhi.

South
DELHI
110049
India 
Phone  7376000060  
Fax  -  
Email  Yash_s@drinkelixir.in  
 
Source of Monetary or Material Support  
Weather Woods Pvt. Ltd. A-41, Second Floor, NDSE part II, South Delhi, Delhi, 110049. 
 
Primary Sponsor  
Name  Weather Woods Pvt Ltd  
Address  A-41, Second Floor, NDSE part II, South Delhi, Delhi, 110049. 
Type of Sponsor  Other [General Manufacturer] 
 
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 Ramshyam Agarwal   Lokmanya Medical Research Centre  Fourth-floor OPD 401-314 B Telco Road Chinchwad 41103
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com  
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Sangvi Multispecialty Hospital  Approved 
Lokmanya Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Focus Elixir  Consume a single serving of one full bottle (60 ml) of Focus Elixir Drink once daily on an empty stomach, ensuring a minimum of 2 hours since the last meal for 14 days.  
Comparator Agent  Placebo  Consume a single serving of one full bottle (60 ml) of Focus Elixir Drink once daily on an empty stomach, ensuring a minimum of 2 hours since the last meal for 14 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Male and female participants aged 18 to 30 years (both inclusive) 2. No or minimal impairment in activities of daily living scoring less than 9 on the Functional Activities Questionnaire (FAQ). 3. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form. 4. No severe anxiety and depression on the GAD 7 and PHQ 9 scales. 5. Able to complete the cognitive assessment tests. 
 
ExclusionCriteria 
Details  1. Inability to perform any of the assessments required for endpoint analysis.
2. Shows signs of Dementia, such as caused by Alzheimers Disease, acquired immunodeficiency syndrome (AIDS), Creutzfeldt Jakob disease (CJD), Lewy Bodies dementia (LBD), Cerebrovascular
dementia (CVD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus (NPH), cardiac disease or endocrine disease.
3. Have any other neurodegenerative diseases.
4. History of a seizure disorder.
5. Known hypersensitivity to investigational products.
6. Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy.
7. Sitting or resting systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at screening.
8. Participants with a history of substance abuse, drugs, heavy use of alcohol, or smoking within the last 5 years.
9. Participants currently using medications and supplements that could have cognitive or mood effects including but not limited to nutraceutical, allopathic, ayurvedic herbal extract or supplement.
10. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. The assessment of acute effects of Focus Elixir Drink evaluated by changes in sustained focus, memory, and freshness questionnaire score recorded pre dose (0 minutes), and 5 hours post dose.
2. Assessment of changes in response time (alertness, orientation, executive control) and executive surveillance hits will be assessed using the ANTI Vea UGR computerized test.
3. Changes in the fatigue severity scale (FSS) score.
4. Changes in Profile of Mood State (POMS) questionnaire score (A. Total Mood Disturbance B. Depression).
5. Changes in the Epworth Sleepiness Scale for daytime sleepiness.
6. Changes in energy levels by using an energy audit diary. 		 1. Day 1.
2. At Days 1 and 14.
3. At screening, day 7 and day 14.
4. At screening and day 14.
5. At screening, day 7 and day 14.
6. At baseline, day 7 and day 14. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Adverse events profile.
2. Treatment compliance and tolerability of investigational product. 		 1. At baseline, day 7 and day 14.
2. At day 7 and day 14. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The rising prevalence of cognitive fatigue, low energy, and mood fluctuations in adults highlights an urgent need for effective, safe interventions. these challenges significantly impair daily functioning and quality of life. Traditional pharmacological treatments, while sometimes effective, often come with side effects such as anxiety and dependency.

Natural dietary supplements are emerging as promising alternatives, particularly those with ingredients like L-carnitine, choline, ginseng, bacopa monnieri, L-tyrosine, L-citrulline malate, and green tea extract. These compounds have demonstrated benefits in enhancing cognitive performance and mood regulation. However, comprehensive studies assessing the synergistic effects of these ingredients in a single formulation are lacking.

Focus Elixir Drink is designed to fill this gap by combining these powerful ingredients into a scientifically formulated beverage aimed at boosting cognitive function, energy levels, and emotional well-being. This study will rigorously evaluate the efficacy and safety of Focus Elixir Drink, providing valuable insights into its potential as a safe, effective alternative to conventional treatments for cognitive enhancement and mental wellness.


 
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