| CTRI Number |
CTRI/2025/02/080847 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy and
Safety Study of Feminine Hygiene Wash |
|
Scientific Title of Study
|
A Randomized, Double-blinded, Comparative Clinical
Study to Evaluate the Efficacy and Safety of Feminine hygiene wash of Cavinkare |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FWASH /36/24 Ver 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuradha MBBS MD |
| Designation |
Principal Investigator |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Obstetrics and Gynecology, SRM Medical College Hospital and Research Centre
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9042038136 |
| Fax |
|
| Email |
anuradhm@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha MBBS MD |
| Designation |
Principal Investigator |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Obstetrics and Gynecology, SRM Medical College Hospital and Research Centre
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9042038136 |
| Fax |
|
| Email |
anuradhm@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Room No 1, No 5/3 Jayalakshmi Street,Radha Nagar, Chromepet- 600 044
Chengalpattu
Chennai
TAMIL NADU
600044
India |
| Phone |
09003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Cavinkare,No.12, Poonthamalle Road, Ekkatuthangal, Chennai, Tamil Nadu-600 032 |
|
|
Primary Sponsor
|
| Name |
Cavinkare, India. |
| Address |
No.12, Poonthamalle Road, Ekkatuthangal, Chennai, Tamil Nadu-600 032 |
| 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 Anuradha MBBS MD |
SRM Medical College Hospital and Research Centre |
Consultation Room, Department of Obstetric and gynecology, Potheri, Chengalpattu, Tamil Nadu 603203
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9042038136
anuradhm@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N908||Other specified noninflammatory disorders of vulva and perineum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Feminine Hygiene Wash of Cavinkare |
Composition: 1.Water 52.98-64.75 2.Cocamidopropyl betane 18.00-22.00 3.Coco glucoside 9.00-11.00 4.Glycerin 2.70-3.30 5.Lauryl glucoside 1.80-2.20 6.Lactic acid 1.80-2.20 7.Fructooligosaccharides 0.90-1.10 8.Soy isoflavones 0.45-0.55 9.Teatree oil 0.009-0.011 10.Ajwain oil 0.009-0.011 11.Carvacrol oil 0.009-0.011 12.Disodium EDTA 0.045-0.055 13.Allantoin 0.045-0.055 14.PEG-150 distearate 0.45-0.55 15.Bio saccharide gum-1 0.45-0.55 16.Sodium hydroxide 0.27-0.33 17.Phenoxyethanol (and) Benzoic acid (and) Dehydroacetic Acid 0.45-0.55 18.EG-40 Hydrogenated castor oil 0.45-0.55 19.Fragrance 0.18-0.22 USAGE: Take required quantity of Feminine Hygiene wash on the palm, and apply on the intimate area. Rinse thoroughly with water. Topical gel- External application Twice daily for 2 weeks |
| Comparator Agent |
VWash PLUS Expert Intimate Hygiene T |
Composition : Lactic Acid 1.2% w/v, Purified water, Triethanolamine Lauryl Sulphate, Ammonium Lauryl Sulphate, Cocamidopropyl betaine, PEG-7 Glyceryl Cocoate, Lactic Acid, Phenoxethanol (and ) Hydroxypropyl Cellulose,Polyquaternium-7, Fragrance , Hippophae Rhamnoides ( Sea Buckthorn), Fruit Oil, sodium Hydroxide,Tea Tree Oil (Melaleuca Alternifolia) Twice daily for 2 weeks Take required quantity on the palm, and apply on the intimate area. Rinse thoroughly with water. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Proper written informed consent obtained from the patient before any procedure performed.
2. Healthy females with perineal discomfort between the age group of 18-65 years.
3. Subjects not have participated in any other clinical trial during the past 3 months |
|
| ExclusionCriteria |
| Details |
1. Female Subjects with sexually transmittable diseases and immune-compromised state &
menstrual irregularities.
2. Pregnant or lactating women
3. Subjects with known history of vaginal candidal infections.
4. Hypersensitivity to any of the components of the test or reference formulation.
5. The presence of any other condition that leads the investigator to conclude that the patient is
inappropriate for inclusion in this clinical study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. An assessment for vulval pH and degree of pruritus,burning, vulvo vaginal erythema and oedema, dryness and dyspareunia
2. Vulval swabs will be taken before administering the
test product for bacterial and fungal culture. Swabs will
also be taken at the end of the study
3. self-assessment scoring by the subject
on subject’s overall condition
4. Quality of life will also be assessed using SF 12
questionnaire |
Baseline and at 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor for any adverse events during the study period |
Baseline to 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 3 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="6"
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
|
The subjects who fulfilled the inclusion criteria and exclusion criteria will be enrolled in the study. 54 Participants will be randomized (double -blinded) into groups.
Group 1- 27 Female Subjects- Feminine Wash of Cavinkare twice daily for two weeks.
Group 2- 27 Female Subjects- Vwash Plus Expert Intimate Hygiene of HUL twice daily for two weeks.
Dosing will done twice daily as topical wash for 2 weeks in the morning and evening . Subjects will be asked to visit the facility on week 1 and week 2
Primary Outcomes
1. An assessment will be made for vulval PH degree of purities, burning, vulvo vaginal erythema and oedema, dryness and dyspareunia before and after the study .
2. Vulval swab will be taken before and end of the study.
3. In last visit, self assessment scoring by the subjects on subjects overall condition will be compared with pre treatment, improved , unchanged and deteriorated
4.Quality of life will be assessed using SF12 questionnaire
|