Effect of Female Gel in hygiene

A RANDOMIZED OPEN LABEL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF NANO LIFE FEMININE GEL(Silver 100% Nano particle) IN FEMININE HYGIENE

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/02/017397

Enrollment

Registered

2019-02-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Nano Life Feminine Gel: Silver 100% nano particle - 20 ppm in gel base Inactive Ingredients: Carbomer, Triethanolamine, water Control Intervention1: V wash and Ellygyn feminine wash: T

Eligibility

Inclusion criteria

Inclusion criteria: 1.Proper written informed consent obtained from the patient before any procedure performed. 2. Healthy females between the age group of 18-40 years. 3. Subjects should not have participated in any other clinical trial during the past 3 months.

Exclusion criteria

Exclusion criteria: 1. Female Subjects with sexually transmittable diseases and immune-compromised state & menstrual irregularities. 2. Pregnant or lactating women & post-menopausal. 3. Subjects with any other co- morbid conditions that can affect the study outcome. 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.

Design outcomes

Primary

Measure	Time frame
An assessment will be made, for vaginal pH and degree of pruritus, burning, vulvo vaginal erythema and oedema, vaginal dryness and dyspareunia. Before the study and post study at 1st week and 2nd week, using a semi-quantitative score between 0 and 4. Vaginal swabs will be taken before administering the study drug for bacterial and fungal culture. Swabs will also be taken at the end of the study (2 weeks) and compared between the two groups for anti-microbial efficacy. Timepoint: DAy 0, 7 and 14	—

Measure

Time frame

An assessment will be made, for vaginal pH and degree of pruritus, burning, vulvo vaginal erythema and oedema, vaginal dryness and dyspareunia. Before the study and post study at 1st week and 2nd week, using a semi-quantitative score between 0 and 4. Vaginal swabs will be taken before administering the study drug for bacterial and fungal culture. Swabs will also be taken at the end of the study (2 weeks) and compared between the two groups for anti-microbial efficacy. Timepoint: DAy 0, 7 and 14

—

Secondary

Measure	Time frame
To monitor for any adverse events during the study periodTimepoint: Day 0, 7 and 14	—

Countries

India

Contacts

Public ContactRamesh Kannan

srkguruvarshan@gmail.com7708925866

Outcome results