| CTRI Number |
CTRI/2025/03/082469 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of swetapradara by shallakyadi Taila yoni pichu |
|
Scientific Title of Study
|
A clinical study on the effect of shallakyadi taila yonipichu in sweta pradara wsr 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 Swetaprava Panda |
| Designation |
2nd year Post graduate student |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya and Hospital Puri |
| Address |
Postgraduate Department of Prasuti Tantra and Stree Roga Gopabandhu Ayurveda Mahavidyalaya and Hospital Puri
Puri
Puri
ORISSA
752002
India |
| Phone |
7750959787 |
| Fax |
|
| Email |
pandakrishnna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusri Sahoo |
| Designation |
Reader |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya and Hospital |
| Address |
Post Graduate department of Prasuti Tantra and Stree Roga Gopabandhu Ayurveda Mahavidyalaya
Puri
Puri
ORISSA
752002
India |
| Phone |
9438560198 |
| Fax |
|
| Email |
dr.manjusrisahoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjusri Sahoo |
| Designation |
Reader |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya and Hospital |
| Address |
Post Graduate department of Prasuti Tantra and Stree Roga Gopabandhu Ayurveda Mahavidyalaya
Puri
Puri
ORISSA
752002
India |
| Phone |
9438560198 |
| Fax |
|
| Email |
dr.manjusrisahoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda mahabidyalaya, puri, odisha |
| Gopabandhu Ayurveda Mahavidyalaya and Hospital,vip road,pin- 752002 Puri, Odisha, India |
|
|
Primary Sponsor
|
| Name |
Dr Swetaprava Panda |
| Address |
Postgraduate Department of Prasuti Tantra and Stree Roga
Gopabandhu Ayurveda Mahavidyalaya and Hospital Puri Odisha |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSwetaprava Panda |
Gopabandhu Ayurveda Mahavidyalaya puri |
Postgraduate Department of Prasuti Tantra and Stree Roga
Gopabandhu Ayurveda Mahavidyalaya puri
Puri
Puri
ORISSA |
7750959787
pandakrishnna@gmail.com |
| DrSwetaprava panda |
Gopabandhu Ayurveda mahavidyalayaand hospital,puri |
PG department Of Prasuti Tantra and Stree Roga,
Puri
ORISSA |
7750959787
pandakrishnna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee, Gopabandhu Ayurveda Mahavidyalaya, puri,Odisha |
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, (2) 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 | Intervention Arm | Procedure | - | yoni picu, योनि पिचु | (Procedure Reference: Susruta Samhita Uttara Tantra , Procedure details: Yoni pichu dipped with medicated oil is induced into the vagina after proper antiseptic measures . The pichu is kept 3 to 4 hours. )
(1) Medicine Name: Shallakyadi Taila , Reference: Astanga , Route: Vaginal, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Married women, c/o white vaginal discharge, having cervical erosion found in p/s examination |
|
| ExclusionCriteria |
| Details |
Unmarried women
Patient with acute systemic disease
Patient with acute genital tract infection
Patient with malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To manage white discharge in cervical Erosion |
28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To manage the symptoms |
28days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="0"
Months="0"
Days="28" |
|
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
|
It is expected that the present clinical study will bring out a standard and effective treatment in the management of swetapradara. |