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临床试验/CTRI/2025/09/095016
CTRI/2025/09/095016尚未招募2/3 期

Comparative Efficacy of Darvyadi Kwatha verses Tranexamic acid 500mg in the management of Raktapradara (Menorrhagia): A Randomized Controlled Trial

Mahatma Gandhi Ayurved College, Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
64
试验地点
1
主要终点
Exploring the efficacy of interventions in managing the full spectrum of Raktapradar Menorrhagia including moderate bleeding regular cycles pelvic discomfort weakness and systemic symptoms with assessment via PBAC score and clinical response

研究概览

简要总结

This clinical trial compares the effectiveness of Darvyadi Kwatha  a traditional Ayurvedic herbal decoction with Tranexamic Acid 500 mg a modern antifibrinolytic drug in managing heavy menstrual bleeding Raktapradara Menorrhagia The study evaluates symptom relief blood loss reduction and overall well being to determine whether Darvyadi Kwatha can serve as a safe and effective alternative therapy

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
19.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Written informed consent from patients willing to participate in the study Females aged 19 to 40 years presenting with classical symptoms of Raktapradar Menorrhagia Women with a baseline PBAC score indicating mild to moderate menorrhagia PBAC score between 100 and 300 will be included in the study Complaints of excessive more than 80ml and or prolonged more than or equal to 8days menstrual bleeding Regular menstrual history for the past three cycles prior to enrollment.

排除标准

  • Patients with known systemic illnesses such as tuberculosis or immunocompromised status Structural or malignant reproductive tract disorders based on clinical evaluation Current use of hormonal therapy oral contraceptive pills or intrauterine contraceptive devices IUCD Patients with bleeding disorders or those on anticoagulant therapy History of ongoing pelvic inflammatory disease Patient unwilling or unable to comply with study requirements.

结局指标

主要结局

Exploring the efficacy of interventions in managing the full spectrum of Raktapradar Menorrhagia including moderate bleeding regular cycles pelvic discomfort weakness and systemic symptoms with assessment via PBAC score and clinical response

时间窗: 2 Months

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shruti Prakash Bhandari

Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha

研究点 (1)

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