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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:N812||Incomplete uterovaginal prolapse. Ayurveda Condition: PRASRAMSINI/PRASRAVINI, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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 | 2 | Comparator Arm | Procedure | - | 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. |