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 Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1) Relief of Menstrual cramps ( VAS score pre and post study)
Study Overview
Brief Summary
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
-
Relief of Menstrual cramps ( VAS score pre and post study)
-
Regulates Menstrual cycles ( whether it is regulating Menstrual cycle and bleeding)
-
Prevents Rashes, Allergies, Skin erosions and surrounding erythema and oedema ( 5 Point Likert scale -pre and post study)
-
Reduce UTI and clear Bacterial Infection (by microbiological swab and urine routine examination- Pre and post study for selected subjects
-
Eliminates Odour ( 5point Likert scale - pre and post study)
-
Control Vaginal white discharge ( 5 point Likert scale- pre and post study)
-
Improves quality of Sex Life ( To check vaginal dryness for women in perimenopausal age group)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female Subjects in the age group of
- •50 years.
- •Subjects diagnosed with Irregular Menstrual Cycles, Dysmenorrhoea and Chronic Vaginal Infection
- •Subjects having Allergies/ rashes while using the Sanitary Pads
- •Subjects having Menstrual Cramps
- •Able to give a proper Informed consent.
Exclusion Criteria
- •Subjects presenting with uncontrolled Diabetes.
- •Pregnant and lactating mother.
- •Immunocompromised subjects with history of HIV, HbsAg and on immunomodulatory drugs.
- •Failure to comply with the study protocol
- •Hypersensitivity to any of the ingredients of the test product.
Outcomes
Primary Outcomes
1) Relief of Menstrual cramps ( VAS score pre and post study)
Time Frame: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
2) Regulates Menstrual cycles ( whether it is regulating Menstrual cycle and bleeding)
Time Frame: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
3) Prevents Rashes, Allergies, Skin erosions and surrounding erythema and oedema ( 5 Point Likert scale -pre and post study)
Time Frame: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
4) Reduce UTI and clear Bacterial Infection (by microbiological swab and urine routine examination- Pre and post study for selected subjects
Time Frame: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
5) Eliminates Odour ( 5point Likert scale - pre and post study)
Time Frame: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
6) Control Vaginal white discharge ( 5 point Likert scale- pre and post study)
Time Frame: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
7) Improves quality of Sex Life ( To check vaginal dryness for women in perimenopausal age group)
Time Frame: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
Secondary Outcomes
- Quality of Life (SF 12) Questionnaire (Baseline and Post study)(Monitoring of Adverse effects if any.)
Investigators
DrUthpala Vadakaluru
Venus Clinic