| CTRI Number |
CTRI/2020/04/024457 [Registered on: 03/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [personal hygeine maintenance] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A safety and efficacy evaluation of a female intimate wash product |
|
Scientific Title of Study
|
A Study to Evaluate the Safety and Efficacy Of Female Intimate Wash Product in Maintaining a Healthy pH and Microflora in Healthy Indian Women. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hema Divakar |
| Designation |
Principal Investigator |
| Affiliation |
Divakar’s Specialty Hospital |
| Address |
Department of Gynecology,Ground Floor,#220, 9th Cross, 2nd phase,
JP Nagar, Next to Nilgiris,
Bangalore
KARNATAKA
560078
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drhemadivakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar,
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar,
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences and Technology Centre, Peenya Industrial Area, No. 3, 1st Main, 1st Phase , Bangalore – 560 058, |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences and Technology Centre |
| Address |
Peenya Industrial Area, No. 3, 1st Main, 1st Phase , Bangalore – 560 058, |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Hema Divakar |
Divakar’s Specialty Hospital |
Department of Gynecology, 1st Floor, #220, 9th Cross, 2nd phase,JP Nagar, Next to Nilgiris,
Bangalore
KARNATAKA |
9482164779
drhemadivakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Divakars Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with history of UTI |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Feminine Intimate Wash product |
As per investigator direction,Topical Application of the product for 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Healthy women in the age group of 18- 55 years.
2. Atleast one instance of UTI in the past 6
months.
3. Women willing to abide by the study protocol
and study restrictions including abstinence from:
use of any other product besides the allotted
product during the study course, changing their usual brand of sanitary products and laundry detergents during the study course,showering/ bathing / cleaning their genitals with the test product on the day of study visit,depilation of pubic hair through topical products/waxing/ shaving (Trimming with scissors allowed)during the study course,oral or topical Anti-biotic/ Anti mycotic/Anti
inflammatory medicine or OTC / products without
informing to the study investigator. |
|
| ExclusionCriteria |
| Details |
1. Women who are pregnant or lactating
2. Women with a known history or present condition of allergic response to any cosmetic products/ fragranced product which may influence the study result.
3. Women with bacterial vaginosis/ candidiasis/
mycotic infections / active psoriasis/ eczema/
other active skin disorder / any form of chronic infection / allergy / disease which may influence the study result.
4. Women in the post menopausal age group
5. Women with vulvo-vaginal dryness
6. Women who are currently taking or had taken
antibiotics course in the past 3 months
7. Women who have changed the contraceptive
medications or Menopausal / Hormonal treatment in the past 3 months or are contemplating to do so. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Safety of Feminine Intimate Wash product |
Day 0, Day 28 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Efficacy of the Feminine Intimate Wash product |
Day 0, Day 28 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2020 |
| Date of Study Completion (India) |
24/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is an Open label, safety and efficacy study.Women will be explained in detail about the study,those willing to participate,will be screened by a gynecologist. Women meeting the eligibility criteria will be enrolled in the study after completing the informed consent process.Day 0 assessments will be performed.Subjects will undergo assessment on week 04 for gynecological assessment,Dermatological assessment,Self assessment and Biochemical measurements for Ph,and Microbiome. |