跳至主要内容
临床试验/CTRI/2024/08/072704
CTRI/2024/08/072704尚未招募2/3 期

An open label randomized controlled clinical study to evaluate the effect of Karanja Kshara Lepa in KarniniYonivyapath visavis Cervical Erosion

Dr Spoorthi Sanjaya Bevur1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月26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
40
试验地点
1
主要终点
Reduction in Size of the erosion

研究概览

简要总结

Cervical Erosion or Cervical Ectopy, is characterized by the replacement of the squamous covering of the vaginal portion of the cervix with columnar epithelium, which remains contiguous with the lining of the endocervix1 . Cervial erosion or ectopy is the commonest lesion of the cervix. The prevelace rate of the erosionwith the parity capturing up to 17%-50% of the population2. The complications encountered by diathermy, cauterization, laser therapy, etc like local operations on the cervix causes menstrual disturbances, reactionary haemorrhages, cervical stenosis, sepsis, perforation of cervix, troublesome vaginal discharge and effect on subsequent pregnancy and child birth. The etimology and features of cervical erosion, it can be corelated to Karnini Yoni Vyapath. The symptoms include Kapha Dushti Lakshana like Shwetha Pichhila Srava, Kandu in Yoni3 . And the main treatment for Karnini Yoni Vyapath is mentioned as Sthanika Shodhana. Going through the Kshara Gunas i.e.Ushna Virya, Tikshna Guna, Vrana Shotha Pachaka, Sroto Shodhaka, Klinnata Shoshaka, Raktatisrava Stambhaka, Ropaka, Kathina Unnata Mamsadi Lekhaka4 . Comparing the line of treatment and the Kshara Gunas, it is observed that Kshara can be used in the treatment of cervical erosion. Few studies have been done previously done with different types of Kshaara in Karnini Yoni Vyapath. Karanja and Apamarga are the easily available drug , it is mentioned as Kshara Dravya’s according to Sushrutha and Vagbhata5,6 Karanja is mentioned as Yonirogahara according to Dhavantrari Nighantu7 . Yashtimadhu Taila has properties like Lekhana, Sodhana, Soshana, Stambhana, Sandhaniya, Ropana and Varnya, Vedanahara 8 . Keeping in view, the above-mentioned symptomatology and problems in treating them, there is a need for an alternative, safe and cost-effective remedy in Ayurvedic system. Hence the study “AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF KARANJA KSHARA LEPA IN KARNINI YONIVYAPATH VIS-À-VIS CERVICAL EROSION” has been undertaken

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Married women, in the age group of 20 to 50 years Subjects diagnosed with Cervical erosion.

排除标准

  • Subjects on oral contraceptive pills, and Intra Uterine Contraceptive Devices Known Case of other cervical lesions like cervical polyp, cervical carcinoma and uterine prolapse Sexually transmitted diseases Known Case of coagulation disorder Other systemic and metabolic disorders like Hypertension, Diabetes mellitus Pregnant women.

结局指标

主要结局

Reduction in Size of the erosion

时间窗: 15 days

Normal appearance of Cervical Mucosa

时间窗: 15 days

次要结局

  • Reduction in the quantity of discharge per vagina(Normal consistency of discharge per vagina)

研究者

发起方
Dr Spoorthi Sanjaya Bevur
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Dr Spoorthi Sanjaya Bevur

JSS Ayurveda Medical College and Hospital

研究点 (1)

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