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CTRI Number  CTRI/2025/08/092899 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on improving focus, mood and energy in adults using Focus Elixir Drink 
Scientific Title of Study   Arandomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Focus Elixir Drink in enhancing focus attention energy levels and anxiety management in adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/42 Version: 2.00; dated 23rd May 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh Lad 
Designation  Principal Investigator 
Affiliation  Ayushri Multispeciality Hospital Pvt.Ltd 
Address  Ground floor - OPD 1, Samadhan Chowk Pimprigoan Pimpri
-
Pune
MAHARASHTRA
411017
India 
Phone  7276301818  
Fax  -  
Email  dr.yogeshladayushrihospital@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ritesh Mathur 
Designation  Director  
Affiliation  f2f food & beverages 
Address  Second Floor, 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, 2nd Floor, NDSE part II
-
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, 110049 
 
Primary Sponsor  
Name  Weather Woods Pvt. Ltd. 
Address  A-41, Second Floor, NDSE part II, South Delhi, Delhi, 110049. 
Type of Sponsor  Other [Nutraceutical] 
 
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 Yogesh Lad  Ayushri Multispeciality Hospital Pvt.Ltd  Ground floor - OPD 1, Samadhan Chowk Pimprigoan Pimpri
Pune
MAHARASHTRA 		 7276301818
-
dr.yogeshladayushrihospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sangvi Multispecialty Hospital   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 (70 ml) of Focus Elixir Drink once daily on an empty stomach ensuring a minimum of 2 hours since the last meal 
Comparator Agent  Placebo  Consume a single serving of one full bottle (70 ml) of Placebo Drink once daily on an empty stomach ensuring a minimum of 2 hours since the last meal 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Male and female participants aged 18-30 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.Nosevere anxiety and depression on STAI and PHQ-9 scales;5.Able to complete the assessment questionnaires
 
 
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 more than 180 mm Hg or diastolic blood pressure more 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;
11.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of 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 attention using Attention Control Scale (ATTC/ACS-20) score
3. Assessment of changes in work productivity & performance based on Individual Work Performance Questionnaire (IWPQ) score
4. Changes in the fatigue severity scale (FSS) score
5. Changes in STAI (State-Trait Anxiety Inventory) score
6. Changes in the Epworth Sleepiness Scale for daytime sleepiness  		 1. at Day 1
2. at Days 1,7 and 14
3. at Days 1,7 and 14
4. at screening ,day7 and day 14
5. at screening ,day7 and day 14
6. at screening ,day7 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   Phase 2 
Date of First Enrollment (India)   10/07/2026 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 anxiety 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 focus, attention and anxiety management. 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 focus, attention, 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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