CTRI/2022/12/048303尚未招募Phase 3 4
Evaluation of comparative efficacy of Eladi kasaya versus Tab Tranexamic acid in the management of Asrigdara (Heavy menstrual bleeding).
Mahatma gandhi ayurved college, hospital and research centre1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年2月1日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- reduction of blood loss calculated by pictorial blood assessment chart
研究概览
简要总结
This clinical trial has been conducted as a research work under the Ph.D. programme.
This is a randomized, single blind, standard controlled, equivalence clinical trial to evaluate the comparative efficacy of Eladi kasaya versus tablet Tranexamic acid in the management of Asrigdara (Heavy menstrual bleeding)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients who are willing to give written consent for the trial.
- •Patients between the age group of 18 to 45years.
- •Patients with excessive bleeding (>80ml) for at least 2 consecutive cycles.
排除标准
- •Patients with any diagnosed uterine organic pathology like Uterine Fibroid, Adenomyosis, Chronic tubo ovarian mass.
- •Polycystic ovaries
- •Patients with systemic diseases like hypertension, diabetes mellitus, congestive cardiac failure etc.
- •Patients with coagulopathy
- •Liver dysfunction
- •Thyroid dysfunction
- •Patients with malignancy or undiagnosed neoplasm.
- •Patients with history of recent abortion.
- •Patients with active genital tuberculosis.
- •Bleeding from the polyps and erosion.
- •IUCD in utero, pelvic endometriosis.
结局指标
主要结局
reduction of blood loss calculated by pictorial blood assessment chart
时间窗: 0,4weeks, 8weeks, 12weeks, 16weeks
次要结局
- safety of given medication through occurance of adverse drug reaction
- reduction in pain assessed by visual analog scale(4weeks, 8weeks, 12 weeks, 16weeks)
- improvement in hemoglobin(0 and 16 weeks)
- quality of life assessment using menorrhagia impact quessionnaire(0 and 16 weeks)
研究者
研究点 (1)
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