| CTRI Number |
CTRI/2026/02/104370 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Ayurvedic Local and Oral Treatment for Women Suffering From Pelvic Organ Prolapse |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Efficacy Of Yoni Balyadi Yoga Ghanvati, Pichu, And Combined Effect In The Management Of Yoni Bramsa With Special Reference To 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 |
Dr Aruna Gohil |
| Designation |
PG Scholar |
| Affiliation |
Parul institute of ayurveda |
| Address |
room no 309, Department of prasuti tantra evum and stree roga, parul institute of ayurveda, faculty of ayurveda, parul university, vadodara.
Vadodara
GUJARAT
390019
India |
| Phone |
9773417897 |
| Fax |
|
| Email |
drarunagohil2211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shriniwas Jadhav |
| Designation |
Associate professor |
| Affiliation |
Parul institute of ayurveda |
| Address |
room no 309, Department of prasuti tantra evum and stree roga, parul institute of ayurveda, faculty of ayurveda, parul university, vadodara.
Vadodara
GUJARAT
390019
India |
| Phone |
9945070999 |
| Fax |
|
| Email |
shriniwasdjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruna Gohil |
| Designation |
PG Scholar |
| Affiliation |
Parul institute of ayurveda |
| Address |
room no 309, Department of prasuti tantra evum and stree roga, parul institute of ayurveda, faculty of ayurveda, parul university, vadodara.
Vadodara
GUJARAT
390019
India |
| Phone |
9773417897 |
| Fax |
|
| Email |
drarunagohil2211@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul institute of ayurved parul university, AP limda, tal waghodia dis vadopdara gujrat india 391760 |
|
|
Primary Sponsor
|
| Name |
parul institute of ayurved |
| Address |
faculty of ayurved parul university AP limda tal waghodia vadodara gujrat india 391760 |
| 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 Aruna Gohil |
PARUL AYURVED HOSPITAL |
opd no 104 ground floor Prasuti tantra evam stree roga department parul ayurveda hospital parul university AP limda tal waghodia vadodara gujrat 391760 india
Vadodara
GUJARAT |
09773417897
drarunagohil2211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IAIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N814||Uterovaginal prolapse, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yoni Balyadi Yoga Ghana vati, Reference: Bhavaprakasha chikitsa 70/47,48, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -- | | 2 | Comparator Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: ashtanga hridaya uttaratantra 32/22-23, 26-27, Procedure details: vaginal tampoon made of cotton & gauze soaked in taila/ghrita/ kashaya is termed as pichu, when it placed in yoni it is called as yoni pichu.)
(1) Medicine Name: yoni balyadi yoga, Reference: bhavaprakasha chikitsa 70/47-48, Route: Vaginal, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 7 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: yoni balyadi yoga ghanavati and yoni balya yoga taila, Reference: bhavaprakasha chikitsa 70/47-48, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -along with medicine yoni pichu is also done for 7 days period for 2consecutive months |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Married women aged between 30-60 years with presenting lakshanas of Andini/ Phalini / Prasramsini
All Parous women
Women with Backache or Dragging pain in pelvis
Women with mass felt per vagina during increased intra-abdominal pressure
Women with uterine prolapse with or without cystocele, urethrocele, rectocele
Patient willing for the trial
|
|
| ExclusionCriteria |
| Details |
Women aged below 30 years and above 60 years.
Pregnant women.
Subjects with congenital anomalies of uterus.
Known case of any malignancy.
Uterine Prolapse with myometrial fibroids more than 5 cm and Subserosal fibroid more than 5cm and cervical polyp
Uterine Prolapse with Decubitus Ulcer
Patient not willing for the trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in degree of POP
Reduction in symptoms of POP |
baseline
4th week 1st follow up
8th week 2nd follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in associated complain
improvement in vaginal muscle tone
safety & tolerability of the trial drugs |
baseline
4th week 1st follow up
8th week 2nd follow up
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/03/2026 |
| 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
|
Pelvic organ prolapse is a common gynecological condition affecting quality of life in women. In Ayurveda, POP can be correlated with Prasramsini /phaliniandini Yonivyapdt. The present study is a randomized comparative clinical trial conducted to evaluate the therapeutic efficacy of Yoni Balyadi Yoga administered as pichu, ghanvati and their combined use in the management of POP. A total of 30 patients fulfilling the inclusion criteria will be randomly allocated into three groups. Group A will receive Yoni Balyadi Yoga pichu, Group B will receive Yoni Balyadi Yoga ghanvati and Group C will receive both pichu and ghanvati. The duration of treatment will be 60 days with appropriate follow up. Assessment will be done based on improvement in degree of Prolapse and associated symptoms such as vaginal heaviness and urinary complaints. The study aims to provide evidence for the efficacy and safety of Yoni Balyadi Yoga in the management of POP |