| CTRI Number |
CTRI/2025/06/089114 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of efficacy of ambashtha-kshiriwalkal taila yoni pichu and jatyadi taila yoni pichu on cervical erosion (garbhashayamukh vrana) |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to compare the efficacy of ambashtha-kshiriwalkal taila yoni pichu and jatyadi taila yoni pichu on cervical erosion (garbhashayamukh vrana) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Priyanka Dilip Bendre |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Rasta Peth,Pune,Maharashtra |
| Address |
Tilak Ayurved Mahavidyalaya,Department of Stree-rog and prasuti tantra,Rasta Peth,Pune
seth Tarachand Ramnath Ayurvedic Hospital,rasta Peth, Pune,Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
9209716208 |
| Fax |
|
| Email |
drbendrepriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Rucha Ganu |
| Designation |
Head of the Department, Department of Stree-Rog and Prasutitantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Rasta Peth,Pune,Maharashtra |
| Address |
Tilak Ayurved Mahavidyalaya,Department of Stree-rog and prasuti tantra,Rasta Peth,Pune
seth Tarachand Ramnath Ayurvedic Hospital,rasta Peth, Pune,Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
9822376936 |
| Fax |
|
| Email |
ganu.rucha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Priyanka Dilip Bendre |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Rasta Peth,Pune,Maharashtra |
| Address |
Tilak Ayurved Mahavidyalaya,Department of Stree-rog and prasuti tantra,Rasta Peth,Pune
seth Tarachand Ramnath Ayurvedic Hospital,rasta Peth, Pune,Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
9209716208 |
| Fax |
|
| Email |
drbendrepriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital,Rasta Peth,Pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Rasta Peth,Pune,411011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrPriyanka Dilip Bendre |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
Department of stree-Rog and Prasutitantra,Ground floor,OPD No.11
Pune
MAHARASHTRA |
09209716208
drbendrepriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,TAMV Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi taila, Reference: Bhaishajya Ratnawali , Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Medicine will be used by the procedure of yoni pichu | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ambashtha Kshiriwalkal, Reference: Chikitsa arnav, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Medicine will be used by the procedure of yoni pichu |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Married female between 25-40 years age group
2.Participant clinically diagnosed with cervical erosion |
|
| ExclusionCriteria |
| Details |
1.Presence of active infection in the genital tract
2.Any growth in genital tract
3.ANC and PNC patient
4.Anaemic patients (Hb less than 8 mg/dl)
5.Serologically positive patient of HIV, HbsAg
6.Patient with sexually transmitted disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Ambashtha-Kshiriwalkal taila yoni pichu on cervical erosion (Garbhashay mukh vrana)in comparison with jatyadi taila yoni pichu |
7 days for 3 consecutive menstrual cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of vaginal discharge |
7 days |
|
|
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)
|
01/07/2025 |
| 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
|
The study will be intervened by the treatment of Ambashtha Kshiriwalkal Taila yoni pichu and Jatyadi Taila yoni pichu to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for stastical analysis. Scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regard to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |