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临床试验/CTRI/2024/11/077097
CTRI/2024/11/077097尚未招募2/3 期

A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF AGNIKARMA WITH PANCHDHATU SHALAKA AND CHANDRODAYA VARTI IN THE MANAGEMENT OF KARNINI YONIVYAPAD W.S.R. CERVICAL EROSION

Dr Sunita Kumari1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年12月23日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1) Reduction in area of erosion with respect to that of cervix.

研究概览

简要总结

Cervical erosion is one of the commonest gynaecological conditions seen in routine clinical practice in which the squamous epithelium of the ectocervix is replaced by columnar epithelium, which is continuous with the endocervix. It is asymptomatic in initial stage but in later stage, it progresses to show symptoms like white discharge, itching, contact bleeding, dyspareunia etc.

Cervical erosion is a benign condition but if left untreated may predispose to cervical malignancy. Hence, early detection and treatment are crucial in managing this condition.

The clear description of Cervical Erosion is not mentioned in Ayurveda classics but can be correlated with â€œKarnini Yonivyapad”“Garbhashaya Grivamukhgata Vrana**”due to its clinical symptoms, etiopathogenesis and managementapproaches. Considering the features of cervical erosion, it can be stated that it is usually Nija /AgantujaKapha-PittajaTwaka- Mansajatype of Karnikaakara Granthiwhich occurs at Mukhaof Garbhashaya.

Cauterization, Cryosurgery, Diathermy and Laser therapy are the most common therapies used in modern science for treating which have their own side effects like bleeding per vagina, perforation of cervix, sepsis, menstrual disturbance, and secondary infertility. So, safe and cost-effective alternative treatment modalities are desirable which treats the condition in a holistic approach and prevent further development and recurrence. So present study is planned to evaluate the effect of Agnikarmawith Panchdhatu Shalakaand Chandrodaya Vartilocally.

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

入选标准

  • Patients with symptoms related to Karnini Yonivyapad.
  • Per speculum examination- bright red area surrounds the external os in the ectocervix with clearly demarcated outer edge.
  • Patients who are willing to go for relevant investigations.
  • Pap smear grading 1, 2 5) Cervical Erosion present after three months of delivery or three months after the stoppage of contraceptive pills.
  • Recurrence case of electro-cauterization after three months of treatment.
  • Suitable for Agnikarma.

排除标准

  • Female patient of age less than 21 years and more than 45 years , Pt age more than 40 years with history of menopausal symptoms.
  • Patients with any diagnosed uterine pathology like Sub-mucosal pedunculated fibroid, Adenomyosis, Endometrial Polyp, Cervical Polyp etc.
  • Patients with coagulopathy 4) Patients with pregnancy, history of last delivery in duration of three months.
  • Known case of sexually transmitted diseases like VDRL, HIV, Gonorrhoea etc.
  • Unsuitable for Agnikarma.

结局指标

主要结局

1) Reduction in area of erosion with respect to that of cervix.

时间窗: Follow up on 7th day, 15th day, 25th day, 35th day

2) To improve the sign and symptoms associated with Karnini Yonivyapad.

时间窗: Follow up on 7th day, 15th day, 25th day, 35th day

次要结局

  • Changes in other associated clinical features related to Karnini Yonivyapad.

研究者

发起方
Dr Sunita Kumari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sunita Kumari

Institute for Ayurved Studies and Research Umri road sector 08 kurukshetra Haryana 136118

研究点 (1)

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