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CTRI Number  CTRI/2025/06/088501 [Registered on: 10/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How effective is Madanaphaladi Yonilepa as a local application in patients with uterine prolapse? 
Scientific Title of Study   Randomized Controlled Clinical Trial to evaluate the effect of Madanaphaladi Yonidrudhikarana Lepa in the management of Prasramsini Yonivyapad 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr AAHNA 
Designation  PG Scholar 
Affiliation  C S M S S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 
Address  OPD No. 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi

Aurangabad
MAHARASHTRA
431011
India 
Phone  6238932990  
Fax    
Email  draahnaanil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandhya M Yennawar 
Designation  Associate Professor 
Affiliation  C S M S S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 
Address  OPD No. 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi

Aurangabad
MAHARASHTRA
431011
India 
Phone  9850562524  
Fax    
Email  dryennawar11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr AAHNA 
Designation  PG Scholar 
Affiliation  C S M S S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 
Address  OPD No. 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi

Aurangabad
MAHARASHTRA
431011
India 
Phone  6238932990  
Fax    
Email  draahnaanil@gmail.com  
 
Source of Monetary or Material Support  
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
 
Primary Sponsor  
Name  CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 
Address  OPD No. 19, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr AAHNA  C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi  OPD No. 19 Prasuti Tantra And Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi
Aurangabad
MAHARASHTRA 
6238932990

draahnaanil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CSMSS Ayurved Mahavidyalaya Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N812||Incomplete uterovaginal prolapse. Ayurveda Condition: PRASRAMSINI/PRASRAVINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Bhaishajya Ratnavali Yonivyapadchikitsa, Sharangadhara Samhita lepa Vidhi Adhyaya, Procedure details: Patient will be kept in lithotomy position after evacuation of bladder. Lepana Aushadha will be applied gently covering the prolapsed part and retained for atleast 2 hours. Thickness of lepa should be 0.5 cm according to Ayurvedic Pharmacopeia of India. After 2 hours, Yoni prakshalana with Sukoshna Jala will be done.)
(1) Medicine Name: Madanaphaladi Lepa, Reference: Bhaishajya Ratnavali Yonivyapad Chikitsa, Route: Vaginal, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 28 Days
2Comparator ArmProcedure-picu, पिचु (Procedure Reference: Susruta Samhita Uttaratantra, Procedure details: After voiding of urine, patient should be kept in lithotomy position. Autoclaved picu should be put into the vagina using index finger such that the thread emerges from vagina.)
(1) Medicine Name: Palasha udumbaradi taila, Reference: Bhaishajya Ratnavali Yonivyapad Chikitsa, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Married and vaginally parous women having complaints of Prasramsini Yonivyapad including 1st degree uterine prolapse with or without 1st degree cystocele or rectocele 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Madanaphaladi Yonidrudhikara lepa in the management of Prasramsini Yonivyapad  Follow up- 14th, 28th 
 
Secondary Outcome  
Outcome  TimePoints 
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
3. To compare the effect of Madanaphaladi Yonidrudhikarana Lepa and Palashaudumbaradi tailayonipichu in the management of Prasramsini Yonivyapad 
Follow up- 14th, 28th 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

According to Ayurveda, common gynecological conditions are referred to as Yonivyapad, which is caused mainly by Vata. Our Acharyas have provided a detailed explanation of pelvic organ displacement or prolapse under the heading of different yonivyapad such as Prasramsini, Phalini/ Andini, and Mahayoni yonivyapad.  As per Acharya Sushrut, any irritation causes excessive vaginal discharge or displacement and labour is difficult or abnormal along with 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 (difficult labour) and lakshana of pitta vitiation. Madhav Nidan, Bhava Prakash and Yoga Ratnakar explained that when there is displacement, excessive discharge, difficult labour and pitta vitiation features.Arunadatta and Indu comments Srasta means descending from its place or descend outward. Hence, it may be correlated to 1st & 2nd degree uterine prolapse.

Globally, Pelvic Organ Prolapse (POP) affects approximately 19.7% of women. Another study estimated a 4.8% prevalence in a specific population. India has 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 disease due to their misinformation, potential embarrassment, cultural, and personal silence about it, despite being symptomatic for a long duration. Therefore, adopting an effective management strategy that is simple, easily available, and easy to administer for initial stages of prolapse is crucial to avoid further complications.

Previous studies focused mostly on veshavara pindadharan, kalka dharan, and yonipichu. Yoni lepana increases the surface area available for drug absorption and improves the drug’s bioavailability by covering the entire prolapsed part. In Bhaishajyaratnavali Yonivyapad Chikitsa, there is a reference to Madanaphaladi yonidrudhikarana lepa, which encompasses Madanaphala, Yashtimadhu, Karpura, and Madhu. The contents of this yoga, which include pittashamak, vatashamak, raktaprasadan, balya, vrishya, and laghu guna, help to strengthen the pelvic floor muscles, improve blood circulation, and minimize related issues.

Study will be conducted on 60 diagnosed patients of Prasramsini Yonivyapad. Written consent will be taken. An initial assessment will be done. Patients treated with interventional group Madanaphaladi Lepa and control group Palashaudumbaradi yonipichu. Patients will be assessed at follow-ups. Observation and Results will be noted and Statistical analysis, Discussion and conclusion will be drawn.

 
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