A Retrospective Analysis of the Data from the Focus Group - Non-Randomised, Single Arm, Non-Comparative, Open Label, Proof of Concept study conducted on Menstura Care Lotion of Nanic Wellness Pvt. Ltd. in Menstruating Females to Regulate Menstrual Cycle, Control Leucorrhea, Regulate Excessive Menstruation and Reduce Dysmenorhea.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- 1. Numerical Rating Scale : Pain : Reduction in pain levels.
研究概览
简要总结
Study Design : Retrospective Analysis of Data from Focus Group - Non Randomised, Single Arm, Non-Comparative, Open Label, Proof of Concept Study
Indication : 1. To Regulate Menstrual Cycle 2. To Control Leucorrhea 3. To Regulate Excessive Menstruation 4. To Reduce Dysmenorrhea
Investigational Product : Menstura Care Lotion of Nanic Wellness Pvt. Ltd. Comparator : None. Not applicable. Dose : 1g/day Dosage : 1 OD for 3 menstrual cycles ROA : Navel application (Nabhi)
Subject Population : Menstruating females willing to provide feedback for three menstrual cycles of their own free will
Number of Subjects : 39 Subjects
Treatment Arm : Single Arm
Assessments 1. Numerical Rating Scale - Pain 2. Numerical Rating Scale - Bleeding Intensity 3. Numerical Rating Scale - White Discharge 4. Cycle Length 5. Feedback of Product
Background of Study : Menstrual health disorders such as irregular menstrual cycles, premenstrual symptoms (PMS), and leucorrhea are common among women and can significantly impact their physical, emotional, and social well-being. Menstura Care Lotion, developed by Nanic Wellness Pvt. Ltd., is a topical herbal lotion designed to help with menstrual cycles, ease PMS symptoms, and control leucorrhea.
Purpose of the study : Menstruating females were provided with Menstura Care Lotion to help regulate menstrual cycle, reduce leucorrhea, reduce dysmenorrhea. Subjects used the product and provided feedback out of their own free will.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects who were willing to use Menstura Care Lotion to regulate Menstrual cycle, control Leucorrhea, regulate excessive menstruation and reduce dysmenorhea.
- •Subjects willing to give informed consent.
- •Subjects willing to give feedback of their own free will.
排除标准
- •Subjects who could not give feedback for three menstrual cycles.
- •Subjects with known hypersensitivity to product ingredients.
结局指标
主要结局
1. Numerical Rating Scale : Pain : Reduction in pain levels.
时间窗: Baseline | End of Cycle 1 | End of Cycle 2 | End of Cycle 3
2. Numerical Rating Scale : Bleeding Intensity : Reduction in bleeding intensity
时间窗: Baseline | End of Cycle 1 | End of Cycle 2 | End of Cycle 3
3. Numerical Rating Scale : White Discharge : Reduction in discharge
时间窗: Baseline | End of Cycle 1 | End of Cycle 2 | End of Cycle 3
4. Cycle Length : Reduction in cycle length
时间窗: Baseline | End of Cycle 1 | End of Cycle 2 | End of Cycle 3
5. Feedback Treatment : Excellent response.
时间窗: Baseline | End of Cycle 1 | End of Cycle 2 | End of Cycle 3
次要结局
未报告次要终点
研究者
Dr VT Sriraam
Yellow Bricks Research Hub