A clinical trial on Ayurveda therapies in cervical erosion

Phase 2

Not yet recruiting

Conditions: Inflammatory disease of cervix uteri,

Registration Number: CTRI/2020/04/024766

Lead Sponsor: National institute of ayurveda

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the cervical erosion on Colposcopic assessment .	8 Week

Secondary Outcome Measures

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

Trial Locations

Locations (1): National institute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
National institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Pratima
Principal investigator
9669468199
chotiprasad@GMAIL.COM