| CTRI Number |
CTRI/2020/10/028409 [Registered on: 14/10/2020] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [yoni pitchu] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cervical erosion ki chikitsa |
|
Scientific Title of Study
|
Effect of Panchwalkal ghrita on Karnini yonivyapad (cervical erosion ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayanka |
| Designation |
MS scholar (PTSR) |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Room no-318 PG Deptt of PTSR Government PG Ayurveda college and hospital varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6306984142 |
| Fax |
|
| Email |
manku.fzd.007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Gupta |
| Designation |
Associate Professor |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Room no-318 PG Deptt of PTSR Government PG Ayurveda college and hospital varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9839076961 |
| Fax |
|
| Email |
deepikagupta0717@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayanka |
| Designation |
MS scholar (PTSR) |
| Affiliation |
Government P.G. Ayurveda College and Hospital Varanasi |
| Address |
Room no-318 PG Deptt of PTSR Government PG Ayurveda college and hospital varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6306984142 |
| Fax |
|
| Email |
manku.fzd.007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurveda College and Hospital Varanasi |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurveda College and Hospital Varanasi |
| Address |
PG Deptt of PTSR Government PG Ayurveda College and Hospital Varanasi |
| 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 |
| Mayanka |
dept of PTSR Government PG Ayurveda college and hospital |
room no 318 PG dept of PTSR Government PG Ayurved college and hospital varanasi
Varanasi
UTTAR PRADESH |
6306984142
manku.fzd.007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government P.G. Ayurveda College and Hospital, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
yoni pitchu |
yoni pitchu with panchwalkal ghrita for 14 days |
| Comparator Agent |
yoni pitchu |
yoni pitchu with goghrita for 14 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient willing for trial.
2.Married women.
3.Age group 20-45 year.
4.Patient has no malignant change on pap smear
examination.
|
|
| ExclusionCriteria |
| Details |
1.Unmarried women.
2.Pregnant women.
3.Puerperal period up to 12 weeks.
4.Patient taking oral contraceptive pills.
5.Patient with any malignant change on pap smear examination.
6.Patient with any genital growth and acute PID.
7.Patient with any systemic disease like diabetes hypertension etc
8.Patient with intrauterine contraceptive device.
9.Patient having any coagulation disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
decrease in vaginal discharge
decrease in area of erosion
decrease in cervical tenderness |
1 to 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief in all associated symptoms |
1 to 2 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/10/2020 |
| Date of Study Completion (India) |
29/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
A CONCEPTUAL STUDY ON KARNINIYONIVYAPAD published in World Journal of Pharmaceutical Research |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is open randomized double arm clinical trail.patients will be taken from OPD and IPD of government PG ayurveda college and hospital varanasi . 30 patients will be treated with panchwalkal ghrita pitchu for 14 days. and 30 patients will be treated with cow ghrita pitchu for 14 days.
in both groups yoni prakshalan with panchwalkal kwath will be also done.
assesement is done on 1st day pre treatment, 14th day post treatment and on follow up on 21st day.
the inference will be made on the basis of statistical analysis of data. |