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Clinical Trials/CTRI/2025/06/088501
CTRI/2025/06/088501Not yet recruitingPhase 2/3

Randomized Controlled Clinical Trial to evaluate the effect of Madanaphaladi Yonidrudhikarana Lepa in the management of Prasramsini Yonivyapad

CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi1 site in 1 country60 target enrollmentStarted: June 25, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To study the effect of Madanaphaladi Yonidrudhikara lepa in the management of Prasramsini Yonivyapad

Study Overview

Brief Summary

According to Ayurveda, common gynecological conditionsare referred to as Yonivyapad, which is caused mainly by Vata. Our Acharyashave provided a detailed explanation of pelvic organ displacement or prolapseunder the heading of differentyonivyapad such as Prasramsini, Phalini/ Andini, and Mahayoniyonivyapad.  As per Acharya Sushrut, any irritation causes excessivevaginal discharge or displacement and labour is difficult or abnormal alongwith that features of pitta vitiation are present. Dalhana explained that,syandate means sravati (vaginal discharge), kshobhita means sanchalita(irritation or displacement), duhprasuscha means dukhena prasuyate (difficultlabour) and lakshana of pitta vitiation. Madhav Nidan, Bhava Prakash and YogaRatnakar explained that when there is displacement, excessive discharge,difficult labour and pitta vitiation features.Arunadatta and Inducomments Srasta means descending from its place or descendoutward.Hence, it may be correlated to 1st &2nd degree uterine prolapse.

Globally, Pelvic Organ Prolapse (POP) affectsapproximately 19.7% of women. Another study estimated a 4.8% prevalence ina specific population. Indiahas witnessed a significant increase in cases of pelvic organ prolapse (POP)over the years. Women tend to be reluctant to seek help for this known diseasedue to their misinformation, potential embarrassment, cultural, and personalsilence about it, despite being symptomatic for a longduration. Therefore, adopting an effective management strategy that issimple, easily available, and easy to administer for initial stages of prolapseis crucial to avoid further complications.

Previous studies focused mostly on veshavarapindadharan, kalka dharan, and yonipichu. Yoni lepana increasesthe surface area available for drug absorption and improves the drug’sbioavailability by covering the entire prolapsed part. In Bhaishajyaratnavali YonivyapadChikitsa, there is a reference to Madanaphaladi yonidrudhikarana lepa, whichencompasses Madanaphala, Yashtimadhu, Karpura, and Madhu. Thecontents of this yoga, which include pittashamak, vatashamak,raktaprasadan, balya, vrishya, and laghu guna, help tostrengthen the pelvic floor muscles, improve blood circulation, and minimizerelated issues.

Study will be conducted on 60 diagnosed patients ofPrasramsini Yonivyapad. Written consent will be taken. An initial assessmentwill be done. Patients treated with interventional group Madanaphaladi Lepa andcontrol group Palashaudumbaradi yonipichu. Patients will be assessed atfollow-ups. Observation and Results will be noted and Statistical analysis,Discussion and conclusion will be drawn.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Married and vaginally parous women having complaints of Prasramsini Yonivyapad including 1st degree uterine prolapse with or without 1st degree cystocele or rectocele.

Exclusion Criteria

  • 2nd degree, 3rd degree prolapse and procidentia Infectious, benign, and malignant growth of genital organs Patients below 30 and above 60 years Prolapse with fibroid uterus/ovarian/vaginal cyst Infectious diseases of genital tract like HIV, VDRL, HBSAG positive cases Those cases require emergency surgery Any systemic illness like chronic cough, Diabetes Mellitus.

Outcomes

Primary Outcomes

To study the effect of Madanaphaladi Yonidrudhikara lepa in the management of Prasramsini Yonivyapad

Time Frame: Follow up- 14th, 28th

Secondary Outcomes

  • 1. To study the concept of Prasramsini Yonivyapad(2. To study the concept of Pelvic Organ Prolapse especially, 1st degree uterine prolapse, cystocele rectocele in detail according to modern)

Investigators

Sponsor
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi
Sponsor Class
Private medical college

Study Sites (1)

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