A Randomized Clinical Trial to Evaluate the Efficacy of Shatavari Ghrita Vaginal Pessary With Shatavari Ghrita Yoni Pichu in the Management of Perimenopausal Vaginal Dryness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Perimenopause is a transitional phase in women commonly associated with symptoms such as vaginal dryness, itching, burning sensation, and dyspareunia due to declining estrogen levels. These symptoms can significantly affect quality of life. In Ayurveda, local therapies such as Yoni Pichu are traditionally used to manage vaginal disorders. The present study aims to evaluate and compare the clinical efficacy of Shatavari Ghrita vaginal pessary and Shatavari Ghrita Yoni Pichu in the management of vaginal dryness in perimenopausal women aged 40–50 years. A total of 60 eligible participants will be randomly allocated into two groups. Clinical outcomes will be assessed using the Visual Analogue Scale (VAS), Vaginal Health Index Score (VHIS), and vaginal pH before and after treatment. The study may help determine an effective, safe, and acceptable non-hormonal Ayurvedic management for perimenopausal vaginal dryness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Day(s) 至 50.00 Day(s)（—）
- 性别
- Female
入选标准
- •• Perimenopausal women aged 40 to 50 years.
- •• Women presenting with vaginal dryness as a primary complaint.
- •• Delayed menstrual cycles (transition phase).
- •• Women who are willing to participate and give informed written consent.
- •• Women with a VAS score 4 for vaginal dryness or associated symptoms like burning irritation or dyspareunia.
- •• Not undergoing any concurrent hormonal replacement therapy (HRT) vaginal estrogen or herbal therapy in the past 1 month.
排除标准
- •• Postmenopausal women (no menstruation for 12 consecutive months).
- •• Women with active vaginal infections STDs or cervical lesions.
- •• Presence of pelvic organ prolapse.
- •• History of vaginal surgeries within the last 6 months.
- •• Use of hormonal replacement therapy vaginal estrogen or other local hormonal treatments within the last 1 month.
- •• Known allergy or hypersensitivity to Shatavari or Ghrita.
- •• Diagnosed cases of pelvic inflammatory disease endometriosis or gynecological malignancies.
研究者
Dr Mohini Kute
Parul Institute of Ayurved vadodara