| CTRI Number |
CTRI/2025/04/085404 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail to study the effect of intravaginal administartion of medicated varahaadi vasa as vaginal tampon in pelvic organ prolpase |
|
Scientific Title of Study
|
Effect of Varahaadi Vasa Yoni Pichu Dharana in Pelvic Organ Prolapse |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjaly Biju |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prasuti Tantra and Streeroga,Government Ayurveda College Tripunithura Ernakulam,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9447723449 |
| Fax |
|
| Email |
biju.anjaly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prauti Tantra and Streeroga, Government Ayurveda College Tripunithura Ernakulam,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prauti Tantra and Streeroga, Government Ayurveda College Tripunithura Ernakulam,Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura,Ernakulam,Kerala,India,682302 |
|
|
Primary Sponsor
|
| Name |
Anjaly Biju |
| Address |
PG Scholar,Department of Prasuti Tantra and Streeroga,Government Ayurveda College Tripunithura,Ernakulam,Kerala,682301 |
| Type of Sponsor |
Other [Self] |
|
|
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 Anjaly Biju |
Government ayurveda college,Tripunithura |
Department of Prasutitantra and Streeroga,Ground floor,hospital buliding ,682301
Ernakulam
KERALA |
9447723449
biju.anjaly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research(Institutional Review Board),Govt.Ayurveda College,Tripunithura,Kochi,Kerala -682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N819||Female genital prolapse, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: kuchumaratantrabhashyam, Procedure details: Varahaadi vasa yoni pichu will be applied intravaginally for 15 days alternatively in
a 1 month excluding the bleeding phase)
(1) Medicine Name: varahaadi vasa, Reference: kuchumaratantrabhashaym, Route: Vaginal, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Patients presenting with POP including cystocele, rectocele, urethrocele, first
degree, second degree and third degree uterine prolapse
Participants who is willing and competent to give consent
Participants willing to take medicines prepared from animal source swine,hen |
|
| ExclusionCriteria |
| Details |
Females with 4th degree uterine prolapse
Decubitus ulcer
Known case of Genital malignancy
Infectious disorders of genital tract like HIV, Hepatitis B, Syphilis
Congenital anomalies leading to prolapse
G) Pelvic Inflammatory diseases
H) Known case of food allergy(pig,hen).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the change of anterior, posterior and middle compartment pelvic organ
prolapse using POP-Q scale |
Alternatively for 15 days in a month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pelvic floor strength before and after treatment using perineometer
Low back ache assessed by visual analogue scale
Urinary incontinence assessed by urinary incontinence scale
|
Alternatively for 15 days in a month |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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 |
|
Date of First Enrollment (India)
|
03/05/2025 |
| 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 Yet Recruiting |
| 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
|
Pelvic organ prolapse (POP) is a bulge or protrusion of pelvic organs and their associated
vaginal segments into or through vagina. It is a common condition leading to genital tract
dysfunction and diminishes the quality of life with a prevalence of 3% to 50%. Prolapse occurs
due to the weakness of supporting structures and suspension mechanism of uterus and vaginal
wall. POP is multifactorial even though evident in women with a greater number of vaginal
deliveries, instrumental delivery, medical conditions like chronic cough, constipation.
Symptoms include feeling of something coming down per vagina, dragging pain in pelvis,
dyspareunia, urinary symptoms and bowel symptoms like incomplete evacuation. Both
nonsurgical and surgical management can be selected appropriately depending on the extent of
descend.
Displacement or prolapse of genital organs are explained by Acharyas as Andini,Phalini,
Prasramsini,Mahayoni yonivyapat.Vatika yonivyapat chikitsa along with sthanika chikitsa is
beneficial in yonivyapat.Yonipichu dharana one among the sthanika procedure can be
effectively utilised for the management of pelvic organ prolapse. The study aims to determine
the effect of Varahaadi vasa yoni pichu dharana in POP mentioned in the
Kuchumaratantrabhashyam.
This is an interventional pre and post study with sample size 26. Subjects aged 40 – 75 years
attending Prasutitantra and Streeroga OPD and IPD of Government Ayurveda college,
Tripunithura diagnosed with Pelvic Organ Prolapse following inclusion and exclusion criteria
will be taken for study. Data collection will be done by clinical observation through case
proforma and relevant investigations will be done and staging will be done according to POP
Q scale. Yonipichu made of Varahaadi vasa will be kept in vaginal canal till the urge of
micturition. Treatment procedure will be done alternatively for 15 days in a 1 month and
follow-up after 1 month. Assessment will be done on 0th day,31st day and 61st day. Change in
Prolapse will be assessed using POP-Q scale, perineometer. Associated symptoms are assessed
using VAS scale and Urinary Incontinence scale. Results will be statistically analysed and
summarised to arrive the conclusion. |