| CTRI Number |
CTRI/2023/11/059831 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Sanitary Pad and Therapy pad] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Zoy Menstrual Health Solution Pads, Zoy Snow
Lotus Therapy Pads and Zoy Green Herbal Organic Sanitary Napkin In women |
|
Scientific Title of Study
|
A randomized, open label, active controlled, clinical
study to evaluate the efficacy and safety of Zoy girl
Menstrual health solution pads, Zoy girl snow lotus
Therapy pads and Zoy girl green herbal organic sanitary
Napkin in women with irregular menstrual cycles,
Dysmenorrhoea and chronic vaginal infection
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrUthpala Vadakaluru |
| Designation |
Assistant Professor and Consultant |
| Affiliation |
Venus Clinic |
| Address |
Venus Clinic, Room no. 2,
No 172- (Old No - 74)
Sankaranaidu Street
Thirupapuliyur
Cuddalore
Cuddalore
TAMIL NADU
607002
India |
| Phone |
|
| Fax |
|
| Email |
druthuv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthi Balan |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
KI3 Private Limited |
| Address |
Thirumalai Medical Centre, Room No 1, THirumalai Medical Centre, No 408, Cuddalore Road Nainarmandapam Puducherry
NO 5/3 JAYALAKSHMI STREET RADHA NAGAR CHROMPET
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 Private Limited |
| Address |
KI3 Private Limited,Room No1 , KI3 OFFICE Regus Centre Level Altius Block No 1 SIDCO Industrial Estate Chennai
NO 5/3 JAYALAKSHMI STREET RADHA NAGAR CHROMPET
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Zoycare Hygiene Private Limited, Indira Nagar, Behind Tamilnadu Theatre, Palladam Road, Tirupur – 641605 |
|
|
Primary Sponsor
|
| Name |
Zoycare Hygiene Private Limited |
| Address |
SF No. 649/3B2, Indira Nagar, Behind Tamilnadu Theatre, Palladam Road, Tirupur – 641605 |
| 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 |
Venus Clinic |
N0 172- (old No-74), Room no. 2, First OPD, Obstetrics and Gynaecology dept.,
Sankaranaidu Street
Thirupapuliyur
Cuddalore
Cuddalore
TAMIL NADU |
7013208734
druthuv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethique De La Nature Association |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N925||Other specified irregular menstruation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ZOY GIRL GREEN HERBAL ORGANIC SANITARY NAPKIN |
Pads to be used monthly during the menstrual cycle, as required for a period of 6 months |
| Intervention |
ZOY GIRL MENSTRUAL HEALTH SOLUTION PADS |
Pads to be used monthly during the menstrual cycle, as required for a period of 6 months |
| Comparator Agent |
ZOY GIRL SNOW LOTUS THERAPY PADS |
Pads to be used monthly during the menstrual cycle, as required for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Female Subjects in the age group of 18 - 50 years.
2. Subjects diagnosed with Irregular Menstrual Cycles, Dysmenorrhoea and
Chronic Vaginal Infection
3. Subjects having Allergies/ rashes while using the Sanitary Pads
4. Subjects having Menstrual Cramps
5. Able to give a proper Informed consent |
|
| ExclusionCriteria |
| Details |
1. Subjects presenting with uncontrolled Diabetes.
2. Pregnant and lactating mother.
3. Immunocompromised subjects with history of HIV, HbsAg and on
immunomodulatory drugs.
4. Failure to comply with the study protocol
5. Hypersensitivity to any of the ingredients of the test product. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Relief of Menstrual cramps ( VAS score pre and post study)
2) Regulates Menstrual cycles ( whether it is regulating Menstrual cycle and bleeding)
3) Prevents Rashes, Allergies, Skin erosions and surrounding erythema and oedema ( 5 Point Likert scale -pre and post study)
4) Reduce UTI and clear Bacterial Infection (by microbiological swab and urine routine examination- Pre and post study for selected subjects
5) Eliminates Odour ( 5point Likert scale - pre and post study)
6) Control Vaginal white discharge ( 5 point Likert scale- pre and post study)
7) Improves quality of Sex Life ( To check vaginal dryness for women in perimenopausal age group)
|
Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of Life (SF 12) Questionnaire (Baseline and Post study)
Monitoring of Adverse effects if any. |
Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2023 |
| Date of Study Completion (India) |
15/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.60 participants will be randomized into 3 groups with 20 in each group. Arm 1: Zoy Girl Menstrual Health Solution pads Arm 2: Zoy Girl Snow Lotus Therapy pads Arm 3: Zoy Girl Green Herbal Organic Sanitary Napkin
Sanitary pads will be used as required for a period of 6 months. Simple random sampling will be done. Evaluation Criteria: Evaluation of the subjects will be done at baseline, end of each month over telecom and at the end of the study. The following parameters will be monitored.
Primary end Points
1) Relief of Menstrual cramps ( VAS score pre and post study) 2) Regulates Menstrual cycles ( whether it is regulating Menstrual cycle and bleeding) 3) Prevents Rashes, Allergies, Skin erosions and surrounding erythema and oedema ( 5 Point Likert scale -pre and post study) 4) Reduce UTI and clear Bacterial Infection (by microbiological swab and urine routine examination- Pre and post study for selected subjects 5) Eliminates Odour ( 5point Likert scale - pre and post study) 6) Control Vaginal white discharge ( 5 point Likert scale- pre and post study) 7) Improves quality of Sex Life ( To check vaginal dryness for women in perimenopausal age group)
|