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临床试验/CTRI/2024/04/065514
CTRI/2024/04/065514尚未招募2/3 期

Effect of Tuttha Pratisaran and Kushthadi Varti in management of Cervical Erosion in married women of reproductive age group: A Randomized Controlled Trial

Dr Arpita Maulik Shah2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月30日最近更新:
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试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
2
主要终点
To evaluate the efficacy of Tuttha Pratisaran and Kushthadi Varti in the management of cervical erosion with percentage reduction in size of cervical Erosion.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, parallel group, open labelled, controlled clinical trial to evaluate the effectiveness of TUTTHA PRATISARAN 1gm daily on erosion site with KUSHTHADI VARTI administered once daily vaginally for 7 days in patients of age 18 - 45 years having cervical erosion. The primary outcome measures will be relief from the symptoms of cervical erosion like Vaginal discharge, odour, pruritis, backache, lower abdominal pain, burning micturation and cervical tenderness before and after treatment on day 30. The secondary outcome measures will be overall improvement in the healing of cervical erosion by examination of Vaginal pH and PAP Smear before and after treatment on day 30. The results obtained will be analysed statistically to draw conclusions from the study.

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
18.00 Year(s) 至 45.00 Year(s)（—）
性别
Female

入选标准

  • •1.Patients having signs and symptoms who fulfill the diagnostic criteria for Cervical Erosion.
  • •2.Patient willing to give consent for the study.

排除标准

  • •Cervical or Uterine Malignancy.
  • •Pregnant patient.
  • •Systemic Diseases like Diabetes Mellitus.
  • •Infections like HIV, VDRL, STD, HPV.
  • •Cervical polyp.
  • •Puerperium
  • •Patient unwilling to give consent.

结局指标

主要结局

To evaluate the efficacy of Tuttha Pratisaran and Kushthadi Varti in the management of cervical erosion with percentage reduction in size of cervical Erosion.

时间窗: Day 0, Day 7, Day 30

次要结局

  • Effect of Tuttha Pratisaran on overall improvement in the healing of cervical erosion by objective criteria, Vaginal pH and Pap Smear Examination.

研究者

发起方
Dr Arpita Maulik Shah
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Arpita Maulik Shah

Government Ayurved College, Nagpur

研究点 (2)

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