Effect of Zoy Menstrual Health Solution Pads, Zoy SnowLotus Therapy Pads and Zoy Green Herbal Organic Sanitary Napkin In wome
Not Applicable
Completed
- Conditions
- Health Condition 1: N925- Other specified irregular menstruation
- Registration Number
- CTRI/2023/11/059831
- Lead Sponsor
- Zoycare Hygiene Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
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
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Relief of Menstrual cramps ( VAS score pre and post study) <br/ ><br>2) Regulates Menstrual cycles ( whether it is regulating Menstrual cycle and bleeding) <br/ ><br>3) Prevents Rashes, Allergies, Skin erosions and surrounding erythema and oedema ( 5 Point Likert scale -pre and post study) <br/ ><br>4) Reduce UTI and clear Bacterial Infection (by microbiological swab and urine routine examination- Pre and post study for selected subjects <br/ ><br>5) Eliminates Odour ( 5point Likert scale - pre and post study) <br/ ><br>6) Control Vaginal white discharge ( 5 point Likert scale- pre and post study) <br/ ><br>7) Improves quality of Sex Life ( To check vaginal dryness for women in perimenopausal age group) <br/ ><br>Timepoint: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
- Secondary Outcome Measures
Name Time Method Quality of Life (SF 12) Questionnaire (Baseline and Post study) <br/ ><br>Monitoring of Adverse effects if any.Timepoint: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month