CTRI/2025/03/082736尚未招募Phase 3 4
Comparative study of Herbal anti- Fibrinolytic with Tranexamic Acid for the Management of Heavy Menstrual Bleeding of Endometrial origin :A Randomized controlled Trial
DrAnuja Sudhakar Pawar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月25日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the menstrual blood loss.
研究概览
简要总结
The study will conducted after obtaining permission from institutional ethical community & will beregistered CTRI India. As per inclusion criteria patient will be selected & screening done at OPD. Subjective & Objective parameters will be checked & noted. Whole research procedure & Aim will be clearly informed to patients hence Form will be signed byenrolled participants & case report form will be filled.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female Patients under reproductive age between menarche and menopause (18-45yrs) 2) Patients with complaints of excessive, prolonged menstrual bleeding or intermenstrual bleeding.
- •Patient with Hb % more than 9gm.
排除标准
- •Patients with thyroid dysfunction.
- •Patients having cervical pathologies like fibroid, carcinoma & polyp, fibroid uterus and malignancies.
- •Patients with IUCD.
- •Patients with threatened or spontaneous abortion or pregnancy related bleeding.
结局指标
主要结局
Reduction in the menstrual blood loss.
时间窗: 3 months
Reduction in the PBAC score less than 100.
时间窗: 3 months
次要结局
- Regular menstrual cycle.(Improvement/ stable in Hb %)
研究者
Dr Anuja Sudhakar Pawar
Bharati vidyapeeth University Pune
研究点 (1)
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