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临床试验/CTRI/2018/04/013081
CTRI/2018/04/013081进行中(未招募)2/3 期

A comparative clinical study of Shonitasthapana Mahakashaya and Bolabaddha Rasa in the management of Asrigdara with special reference to dysfunctional uterine bleeding

National institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月28日最近更新:
适应症

试验速览

阶段
2/3 期
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Improvement in symptoms and signs of dysfunctional uterine bleeding

研究概览

简要总结

The present clinical study entitled â€œA Comparative Clinical Study Of Shonitasthapana Mahakashaya And Bolabaddha Rasa In The Management Of Asrigdara With Special Reference ToDysfunctional Uterine Bleeding†is randomized parallel group trial to compare the efficacy of Shonitasthapana Mahakashaya Ghana 500 mg BD and Bolabaddha Rasa 500 mg BD for 2 months with following aims and objectives

1.     To study the conceptual aspect of Asrigda**raaccording to Ayurveda.

2.     To study the detailed etio-pathogenesis of the Asrigdara according to Ayurvedaand modern literature.

3.     To evaluate the therapeutic efficacy of Shonitasthapana Mahakashayaon Asrigdara.

4.     To evaluate the therapeutic efficacy of Bolabaddha Rasa on Asrigdara.

5.     Comparative study of Shonitasthapana Mahakashayaand Bolabaddha Rasaon Asrigdara.

Assessment will be done on the basis of subjective parameters i.e amount of bleeding, interval of cycle, bodyache , giddiness etc, objectiveparameters i.e pallor and laboratory investigations i.e CBC and ESR

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
12.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Patients complaining of Asrigdara as a cardinal symptom.
  • 1.Heavy menstrual bleeding (amount >80ml) or 2.Prolonged menstrual bleeding (duration >7 days) or 3.Inter menstrual bleeding or 4.Frequent menstrual cycle (interval< 21 days).

排除标准

  • 1.Pregnant women.
  • 2.Patients having bleeding due to abortion.
  • 4.Patients having coagulation disorders.
  • 5.Any type of malignancy.
  • 6.Patients having STIs. 7.Patients having systemic diseases.
  • 8.Patients having bleeding due to uterine or pelvic pathology 9.Patients using IUCD.

结局指标

主要结局

Improvement in symptoms and signs of dysfunctional uterine bleeding

时间窗: 3 months

次要结局

  • Restoration of normal menstrual cycle i.e amount and interval(6 months)

研究者

申办方类型
Government medical college

研究点 (1)

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