| CTRI Number |
CTRI/2024/05/068016 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of
Feminine Hygiene Wash of Cavinkare |
|
Scientific Title of Study
|
A Randomized Double blinded Comparative Pilot
Clinical Study to Assess the Efficacy and Safety of
Feminine Hygiene Wash of Cavinkare |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FWASH /10/24 version 1.0, dated 01.05.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uthpala Vadakaluru |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Room no 5, Department of Obsttetrics ang Gynaecology, Mahatma Gandhi Medical College and Research Institute, Pondicherry.
Pondicherry
PONDICHERRY
607403
India
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7013208734 |
| Fax |
|
| Email |
druthuv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uthpala Vadakaluru |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Room no 5, Department of Obsttetrics ang Gynaecology, Mahatma Gandhi Medical College and Research Institute, Pondicherry.
Pondicherry
PONDICHERRY
607403
India
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7013208734 |
| Fax |
|
| Email |
druthuv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Room no. 1, Office of the Director, Clinical Trial Department, Regus Office Centre Services (Chennai) Pvt Ltd. Olympia Technology Park, Level - 2, Altius Block, No -1, SIDCO Industrial Estate
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| 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 Uthpala Vadakaluru |
Mahatma Gandhi Medical College hospital and Research Institute |
Room no 5, Department of Obsttetrics ang Gynaecology, Mahatma Gandhi Medical College and Research Institute, Pondicherry.
Pondicherry
PONDICHERRY |
7013208734
druthuv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Research Institute- Institutional Human 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="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
08/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
- 24 participants will be randomized (double-blinded) into groups
- Group 1- female subjects use feminine hygiene wash of cavincare for feminine hygiene twice for daily 2 weeks
- Group 2 - female subjects use - VWash Plus expert intimate hygiene of HUL for feminine hygiene twice for daily 2 weeks
Dosing will done twicw 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 overal condition will be compared with pre treatment, improved, unchanged and deteriorated. 4. based on above three primary outcomes, the efficacy of treatment will be assessed by the investigator. 5. Quality of life will be assessed using Sf 12 questionnaire. |