| CTRI Number |
CTRI/2025/10/095947 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the effect of Mayaphalaadi Yoga as a vaginal pack and cream in treating vaginal looseness and pelvic organ prolapse |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Mayaphalaadi Yoga as Yoni Potali and cream in Yonishaithilyta 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 Mudita Tiwari |
| Designation |
PG Scholar |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
Prasuti Tantra evum Stree Roga vibhag, Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8319959845 |
| Fax |
|
| Email |
dr.mudita96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basanti Guru |
| Designation |
Professor and H O D |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
Prasuti Tantra evum Stree Roga vibhag, Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
09827579276 |
| Fax |
|
| Email |
basantiayu75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basanti Guru |
| Designation |
Professor and H O D |
| Affiliation |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
Prasuti Tantra evum Stree Roga vibhag, Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
09827579276 |
| Fax |
|
| Email |
basantiayu75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP |
|
|
Primary Sponsor
|
| Name |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP |
| Type of Sponsor |
Government 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 Mudita Tiwari |
Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal |
Prasuti Tantra and Stree Roga vibhag, Pandit Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP 462003
Bhopal
MADHYA PRADESH |
8319959845
dr.mudita96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee pandit khushilal sharma govt ayurveda college and institute ,Bhopal ,Madhya Pradesh |
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 | Comparator Arm | Procedure | - | lepa लेप | (Procedure Reference: Gad Nigrah, Procedure details: Mayaphalaadi yoga in the form of vaginal cream
The therapy will be given in 2 sittings of 15 days each with gap of 15 days for Menstruating women the procedure will be given in two consecutive cycles after the cessation of menses in each cycle. )
(1) Medicine Name: Mayaphalaadi yoga, Reference: Gad Nigrah, Route: Vaginal, Dosage Form: Not Applicable, Dose: 5(g), Frequency: od, Duration: 45 Days | | 2 | Intervention Arm | Procedure | - | lepa लेप | (Procedure Reference: Gad Nigrah, Procedure details: Yoni Potali containing Mayaphalaadi yoga.The therapy will be given in 2 sittings of 15 days each with gap of 15 daysFor menstruating women, t the procedure will be given in two consecutive cycles after the cessation of menses in each cycle )
(1) Medicine Name: Mayaphalaadi Yoga, Reference: Gad Nigrah, Route: Vaginal, Dosage Form: Not Applicable, Dose: 05(g), Frequency: od, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Married women or Sexually active women above the age group of 30 years and less than 60 years.
Patients with signs and symptoms of Pelvic organ prolapse and vaginal laxity.
Patients with stage 1, 2 and 3rd degree of uterine prolapse, cystocele or urethrocele, enterocele, rectocele, and vault prolapse.
Patients who will give written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Pregnant and postnatal women.
Patients suffering from benign, malignant, or infectious growth of genital organs and procidentia.
Sexually inactive patients who are virgins.
Patients having pelvic inflammatory disease or cervicitis.
Accidental injury of a genital organ. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of the effect of Mayaphalaadi Yoga in the management of Yoni Shaithilyta or pelvic organ prolapse through Pelvic Organ Prolapse Quantification Test |
Evaluations are done at day 1, just after the completion of therapy and after 15 days of completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in increased frequency of micturition
2. Reduction in Stress Urinary Incontinence
3. Reduction in Straining during Defecation
4. Reduction in feeling of incomplete bowel evacuation |
Evaluations are done at day 1, just after the completion of therapy and after 15 days of completion |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/11/2025 |
| 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="0"
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
|
The study will be conducted to assess the effect of mayaphalaadi yoga as yoni potali and cream in yonishaithilyta, or pelvic organ prolapse. The study will be conducted in married or sexually active women with signs and symptoms of pelvic organ prolapse and vaginal laxity from IPD, OPD of the Department of PTSR, Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, MP, in the age group of 30 to 60 years, who satisfy the inclusion and exclusion criteria. The primary outcome is the assessment of the effect of mayaphalaadi yoga in yonishaithilyta or pelvic organ prolapse, through pelvic organ quantification test, and secondary outcomes are the reduction in increased frequency of urination, stress urinary incontinence, straining during defecation, and the feeling of incomplete bowel evacuation through the PFDI 20 scoring system. Evaluations will be done on day 1, just after the completion of the therapy and after 15 days of completion. |