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CTRI Number  CTRI/2024/03/064117 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 12/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Homeopathy
Nutraceutical 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Assessment of effect of health supplements in healthy humans. 
Scientific Title of Study   Assessment of safety and efficacy of Nutraceutical supplements/AYUSH medicines in healthy human volunteers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/23-24/040-MHC/CT/23-24/048,Ver: 1.00; dated 25Jan2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V G Vaidya 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre 
Address  Fourth-floor OPD 401 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411057
India 
Phone  9822057766  
Fax  -  
Email  vgvclinical@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandip Mali 
Designation  Manager Research and Development 
Affiliation  Herbolab India Pvt. Ltd. 
Address  3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East.

Mumbai
MAHARASHTRA
400072
India 
Phone  9702913695  
Fax  -  
Email  sandip.mali@rpsg.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare Pvt. Ltd. 
Address  fifth floor, Office no. 501-514, Bhumkar square, Crossroads, Wakad.

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  drgayatri@mprex.in  
 
Source of Monetary or Material Support  
HERBOLAB INDIA PVT LTD Floor - 6th, F-15 ,Plot 78, Commerce Centre, Pandit Madan Mohan Malviya Marg, Tardeo, , Mumbai, 400034 
 
Primary Sponsor  
Name  HERBOLAB INDIA PVT LTD 
Address  3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East MUMBAI, MAHARASHTRA, 400072. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 V G Vaidya  Lokmanya Medical Research Centre and Hospital  Fourth-floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 
9822057766
-
vgvclinical@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of 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  ACTS-4 Gummies   Two gummies daily, 30-45 minutes before bed for 30 days.  
Intervention  ASL-3 Gummies   Two gummies daily after meal for 30 days.  
Intervention  BASE-7 Tablet   One tablet daily after meal for 30 days.  
Intervention  CAM-8 Tablet   One tablet daily after meal for 30 days.  
Intervention  CSYM-5 Tablet   One tablet twice a day after meal for 30 days.  
Intervention  GHS-6 Powder  One sachet daily after meal for 30 days.  
Comparator Agent  NIL  NIL 
Intervention  RR-6 DROP   Put 6 - 7 drops into drink of your drink of choice or put 6 - 7 drops on your tongue for 30 days.  
Intervention  SAV-5 Chewables   One tablet daily after meal for 30 days.  
Intervention  SSG-3 Tablet   One tablet daily after meal for 30 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Healthy male and female human trial participants aged between 18 and 60 years (both inclusive);2. Female trial participants must have a negative urine pregnancy test prior to the housing;3. Male and females agreeing to use the contraceptive pill or abstinence as a method of contraception during and 07 days after completion of the study;4. Trial participants with a BMI between 18.50-29.90 kg per m2 and body mass, not less than 50.00 kg;5. Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests). 
 
ExclusionCriteria 
Details  1.Incapable of understanding the informed consent information;
2.Clinically significant medical condition, such as, but not limited to,
cardiovascular, neurological, psychiatric, pulmonary, renal,
immunological, endocrine (including uncontrolled diabetes or thyroid
disease), or uncontrolled haematological abnormalities;
3.History or presence of alcoholism or drug abuse;
4.History or presence of cancer;
5.Use of any prescribed medication (including herbal remedies)
during the two weeks before the start of the study or OTC medicinalproducts (including herbal remedies) during the week before study initiation and throughout the study;
6.Major illness during the 90 days before screening;
7.Pregnant women and nursing mothers;
8.Males and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study;
9.Consumption of dietary supplements likely to provide
constituents similar to the investigational product in last 3 days. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety Assessment, Adverse events, Changes in CBC, LFT, and RFT parameters on screening and day 30.  Screening and day 30. 
 
Secondary Outcome  
Outcome  TimePoints 
Efficacy testing by questionnaires.  screening and day 30. 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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/ Phase 3 
Date of First Enrollment (India)   21/03/2024 
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  

Nutraceutical supplements/AYUSH medicines often contain concentrated forms of bioactive compounds or extracts from food sources. Assessing their safety ensures that consumers are not exposed to excessively high levels of these compounds, which could potentially lead to adverse effects. Nutraceutical supplements/AYUSH medicines frequently combine multiple ingredients, sometimes with synergistic or antagonistic effects. Safety assessments help identify potential interactions between these ingredients and evaluate their combined effects on health. Nutraceutical supplements/AYUSH medicines may be formulated to enhance the bioavailability or absorption of specific nutrients or compounds. Safety assessments consider not only the safety of the ingredients themselves but also the safety of any delivery mechanisms or formulation techniques used to improve their effectiveness. Nutraceutical supplements/AYUSH medicines are often marketed for their potential health benefits in addressing specific conditions or promoting overall wellness. Safety assessments help ensure that these products deliver their intended effects without causing harm to consumers. Many Nutraceutical supplements/AYUSH medicines are intended for long-term use to support overall health or manage chronic conditions. Safety assessments provide valuable information about the potential risks associated with prolonged consumption and help establish safe usage guidelines. Nutraceutical supplements/AYUSH medicines may undergo additional processing or extraction steps to isolate active compounds, increasing the importance of safety assessments to ensure the absence of contaminants or adulterants that could compromise product quality. Consumers often perceive Nutraceutical supplements/AYUSH medicines as natural alternatives to pharmaceuticals and expect them to be safe and free from side effects. Rigorous safety assessments help meet these expectations and build trust in the efficacy and safety of Nutraceutical supplements/AYUSH medicinesNutraceutical supplements/AYUSH medicines are subject to regulations governing their safety, labeling, and marketing claims. Comprehensive safety assessments are essential for regulatory compliance and market authorization, ensuring that products meet established safety standards before they reach consumers. Overall, the assessment of safety in Nutraceutical supplements/AYUSH medicines is essential for ensuring the integrity, efficacy, and safety of these products, meeting consumer expectations, and maintaining regulatory compliance in a rapidly growing and evolving industry.

 
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