跳至主要内容
临床试验/CTRI/2020/04/024766
CTRI/2020/04/024766尚未招募2 期

A Randomized open label comparative clinical study of Agnikarma and Virechana karma in the management of Karnini yonivyapad with special referance to Cervical Erosion

National institute of ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月5日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Improvement in the cervical erosion on Colposcopic assessment .

研究概览

简要总结

Gynecological disorders are those disorders that affectthe female reproductive system. Cervical erosion is one of them. Normallyendocervix is covered by columnar epithelium and ectocervix is covered bysquamous epithelium, but in erosion, it is replaced by columnar epithelium.Many of the times infection is the reason for change in epithelial covering.But sometimes hormonal changes also play a pivotal role in the changes ofepithelial lining, patient suffers with offensive, irritant, profuse vaginaldischarge, formation of nabothian follicle, contact bleeding, dyspareunia,intermenstrual bleeding, bowel irritating pelvic pain etc. If it is associatedwith cervicitis that leads to low back pain. It is also a cause of infertilityand constitutional ill-health and sometimes it produces great psychologicalupset in women. If it is left untreated, in the chronic stages the columnarepithelium undergoes squamous metaplasia.

In Ayurveda classics almost all of thegynecological disorders are described under the topicof yonivyapad which are twenty in numbers.Karnini Yonivyapadis oneamong them, seems to be near to Cervical erosion. . Its prevalence is morethan 50% of all the gynecological conditions

In thepresent study two procedures are selected for comparison purpose in which firstis Agnikarma and second is Virechana karma. Acharya Charaka quoted thatthere is a chance of recurrence in disease treated by shaman therapy butShodhan therapy cure the disease from its root and there is no chance ofrecurrence.  For that Virechana karma has been selected as a Panchkarmaprocedure in present study.Virechana karma have been described in variousSamhitas for Yonidosha .and GranthiChikitsa.Thereis need of study to rule out the  effective, safer and economical methodsof  Doshas shodhna for the management of cervical erosion.30 patients suffering from  karnini Yonivyapad (Cervical erosion) from OPD& IPD National Institute of Ayurveda, Jaipur will be selected according to the inclusion criteria , irrespective of religion,occupation and socio-economic status. Patients will be randomly divided intotwo groups. In group A  Agnikarma with shalaka  and group B Virechanakarma  with Trivrit lehya.

Agnikarmaprocedure - The patient is in lithotomyposition and the part is cleaned with aseptic solutions and draping done.Speculum is to be introduced into the vagina and assessment of the cervicalerosion done. Then cervix is to be cleaned. There afterAgnikarma  done by sterile pre heated shalaka instrument applied to theeroded part of cervix.The sign of Samyaka Dagdha is the Kapota / Talaphalavataand bluish brown colour will be marked.

Virechanakarma procedure -  First of all  Deepana ,Pachna withPanchkola churna(3gm ) twice a day before food till apperances of Niramalakshana,snehapana with Go ghrita till samyaka snigdha lakshna.than virechana  karma will be induced by  Trivrit lehya.Virechana karma followed by Sansarjana karma per the type of shuddhi.

Colposcopy will be used as the objective parameter,follow up will be done after 7 days of treatment which will be carried out for1 month. Assessment will be done on the basis of objective and subjectiveparameter before treatment, after treatment,  and during last follow up.Appropriate statistical test will be applied.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Clinically diagnosed patients of cervical erosion (Karnini) by per speculum examination.
  • Patient willing to consenting undergo trial.
  • Married women irrespective of parity.
  • Age between 20 to 45 years.

排除标准

  • Patient not consenting to the trial.
  • Pregnant women having cervical erosion.
  • Patients positive with Human Immunodeficiency Virus, VDRL and HBs Ag 4)Patients with Intra Uterine Contraceptive Device insertion or on Oral contraceptive pills.
  • Any organic pathology of reproductive tract like endometrial cancer, cervical cancer, cervical intraepithelial neoplasia.
  • Patient having severe systemic disorders like Diabetes, Hypertension, Tuberculosis etc.
  • Patients with Menorrhagia, Metrorrhagia and Polymenorrhoea.

结局指标

主要结局

Improvement in the cervical erosion on Colposcopic assessment .

时间窗: 8 Week

次要结局

  • To relief in associated symptom like white discharge p/v, lowback pain etc.

研究者

申办方类型
Research institution and hospital

研究点 (1)

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