| 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
|
|
|
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
|
|
|
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 medicines. Nutraceutical 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. |