| CTRI Number |
CTRI/2025/01/079785 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Randomised controlled clinical trial of palash taila yonipichu in management of garbhashaya mukhgata vrana w.s.r to cervical erosion. |
|
Scientific Title of Study
|
Randomised controlled trial of palash taila yonipichu in management of garbhashay mukhagata vrana w.s.r to cervical erosion. |
| 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 Shravani Abhay Pawar |
| Designation |
PG scholar streeroga prastutitantra department |
| Affiliation |
Shree saptashrungi ayurveda mahavidya and hospital kamal nagar hirawadi nashik |
| Address |
OPD no 3 ground floor shree saptashrungi ayurveda mahavidya and hospital hirawadi kamal nagar nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7972883223 |
| Fax |
|
| Email |
drshravanipawar2810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shravani Abhay Pawar |
| Designation |
PG scholar streeroga prastutitantra department |
| Affiliation |
Shree saptashrungi ayurveda mahavidya and hospital kamal nagar hirawadi nashik |
| Address |
OPD no 3 ground floor shree saptashrungi ayurveda mahavidya and hospital hirawadi kamal nagar nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7972883223 |
| Fax |
|
| Email |
drshravanipawar2810@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil More |
| Designation |
HOD |
| Affiliation |
Shree saptashrungi ayurveda mahavidya and hospital kamal nagar hirawadi nashik |
| Address |
OPD no 3 shree saptashrungi ayurveda mahavidya and hospital kamal nagar hirawadi nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423934505 |
| Fax |
|
| Email |
moresunil263@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree saptashrungi ayurveda mahavidyalaya and hospital
kamal nagar hirawadi nashik maharashtra india 422003 |
|
|
Primary Sponsor
|
| Name |
Shree saptashrungi ayurveda mahavidya and hospital kamal nagar hirawadi nashik |
| Address |
OPD no 3 ground floor shree saptashrungi ayurveda mahavidya and hospital kamal nagar hirawadi nashik 422003 |
| 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 shravani Abhay Pawar |
Shree saptashrungi ayurveda mahavidya and hospital kamal nagar hirawadi nashik |
OPD no 3 ground floor shree saptashrungi ayurveda mahavidya and hospital kamal nagar hirawadi nashik
Nashik
MAHARASHTRA |
7972883223
drshravanipawar2810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC shree saptashrungi ayurveda mahavidyalaya and hospital kamal nagar hirawadi nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N72||Inflammatory disease of cervix uteri. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Betadine vaginal pessary | Betadine vaginal pessary for 7 days p/v | | 2 | Intervention Arm | Procedure | - | Yonipichu | (Procedure Reference: Charak samhita atisar adhyaya, Procedure details: Yonipichu of palash taila in prathamavarta of yoni for 6 days & removal after 4 hrs of administration.)
(1) Medicine Name: Palash taila, Reference: Sushruta sutrasthan 45/121, Route: Vaginal, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 6 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
20-40 married women
C/o white discharge, backache , generalised weakness, cervical erosion on per speculum examination. |
|
| ExclusionCriteria |
| Details |
Women with uncontrolled DM
Unmarried women and virgins
Pregnant women
Women on oc pills
Patients with IUCD
Patients with cervical polyp
Patients with cervical malignancy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced symptoms of white discharge p/v , backache and generalised weakness with reduced cervical erosion on per speculum examination |
In 7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
|
| Reduced and healed cervix with no erosion |
In 7 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
09/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/02/2025 |
| 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
|
Primary objectives- to evaluate the efficacy of palash taila yonipichu in management of garbhashay mukhagata vrana w.s.r to cervical erosion.
Secondary objective - to study the literature of garbhashay mukhagata vrana w.s.r to cervical erosion. To study the procedure of yonipichu from classical ayurveda text.
Duration of drug administration - 6 days Time - 4 hrs in situ
Time of application - 7th to 12th day of menstrual phase.
Follow up - in between 7th to 12th of menstrual cycle after bleeding phase
Inclusion criteria -women with age between 20-40 yrs Vaginal discharge, backache , clinically diagnosed case of garbhashay mukhagata vrana On p/s examination.
Exclusion criteria - virgins , unmarried women, pregnant women, patients with cervical polyp , patients with cervical malignancy, patients with uncontrolled DM , patient on oc pills , patients with IUCD
Data analysis:
Data will be analysed using appropriate statistical method to compare the effectiveness of the intervention on the primary and secondary outcomes . |