| CTRI Number |
CTRI/2020/02/023350 [Registered on: 14/02/2020] Trial Registered Prospectively |
| Last Modified On: |
11/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
In vitro studies |
| Study Design |
Other |
|
Public Title of Study
|
Effects of ingredients on improving Lactobacillus for vaginal health |
|
Scientific Title of Study
|
Studies on the Pre-biotic and biological activities of ingredients/formulations
for improving vaginal health - in vitro study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Usha Viswanath |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Medical Centre |
| Address |
No 1 Ramachandra Nagar Sri Ramachandra Nagar Porur, Chennai Tamil Nadu 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
04445928916 |
| Fax |
|
| Email |
srmcclinicalresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Kumar P |
| Designation |
Senior Lead Scientist |
| Affiliation |
Cavinkare Private Limited |
| Address |
No12
Poonamalle Rd
Balaji Nagar
Ekkatuthangal
Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
04422251011 |
| Fax |
|
| Email |
maheshkumar.p@cavinkare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Kumar P |
| Designation |
Senior Lead Scientist |
| Affiliation |
Cavinkare Private Limited |
| Address |
No12
Poonamalle Rd
Balaji Nagar
Ekkatuthangal
Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
04422251011 |
| Fax |
|
| Email |
maheshkumar.p@cavinkare.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cavinkare Pvt Ltd |
| Address |
No 12
Poonamalle Rd Balaji Nagar Ekkatuthangal Chennai Tamil Nadu 600032 |
| Type of Sponsor |
Research institution |
|
|
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 Usha Viswanath |
SriRamachandra University |
No.1 Ramachandra Nagar Sri Ramachandra Nagar Porur, Chennai Tamil Nadu 600116
Chennai
TAMIL NADU |
04445928916
srmcclinicalresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female volunteers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Female subjects aged between 18 to 3 5 years who are in active menstrual cycle with Informed Consent signed by subjects/patients for collection of vaginal clinical swabs for research purpose. |
|
| ExclusionCriteria |
| Details |
Feeding mothers/pregnant women
Subjects suffering from any clinically proven diseases/condition/any infective or contagious diseases.
Subjects who are under antibiotic treatment for past 15 days
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Understanding the growth kinetics of Lactobacillus for vaginal health improvement |
Day 1 sample collection and processing experiments
Day 10 sample analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of better formultions for vaginal health |
Day 1 sample collection and processing experiments
Day 10 sample analysis |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
02/03/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The vaginal clinical swab will be collected from hospital post swabbing by the clinicians. The swabs will transported and Lactobacilli will be isolated and characterized. Lactobacilli isolated from clinical swabs will be plated on the Vaginal epithelial cells line and allowed to adhere. These cells will be treated with ingredients/formulations to understand their ability to adhere to the cells in the presence and absence of the active ingredients. |