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Effect of Zoy Menstrual Health Solution Pads, Zoy Snow Lotus Therapy Pads and Zoy Green Herbal Organic Sanitary Napkin In women

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059831
Enrollment
60
Registered
2023-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N925- Other specified irregular menstruation

Interventions

Intervention1: ZOY GIRL MENSTRUAL HEALTH SOLUTION PADS: Pads to be used monthly during the menstrual cycle, as required for a period of 6 months Control Intervention1: ZOY GIRL SNOW LOTUS THERAPY PADS

Sponsors

Zoycare Hygiene Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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) Timepoint: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month—

Secondary

MeasureTime frame
Quality of Life (SF 12) Questionnaire (Baseline and Post study) Monitoring of Adverse effects if any.Timepoint: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

KI3 Private Limited

saheerose@gmail.com9443627722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026