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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Relief of Menstrual cramps ( VAS score pre and post study)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1) Relief of Menstrual cramps ( VAS score pre and post study)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
5) Eliminates Odour ( 5point Likert scale - pre and post study)
时间窗: 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)
时间窗: 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)
时间窗: Day 0, 1month, 2 months, 3 months, 4 months , 5 month and 6th month
次要结局
- Quality of Life (SF 12) Questionnaire (Baseline and Post study)(Monitoring of Adverse effects if any.)
研究者
DrUthpala Vadakaluru
Venus Clinic