| CTRI Number |
CTRI/2025/02/081132 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the efficacy of medicated cotton ball dipped in Jatyadi Taila and Durvadyam Taila inserted in vagina in the management of white discharge |
|
Scientific Title of Study
|
A randomized open labelled comparative clinical study to evaluate the efficacy of Jatyadi Taila with Durvadyam Taila Yoni Pichu in the management of 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 Shweta Jagade |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga,Room no 10,Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km Kanakapura Road, Udayapura P.O, Bengaluru-560082
India
sri sri ayurvedic hospital pg girls hostel bangaluru
Bangalore
KARNATAKA
560082
India |
| Phone |
8806918513 |
| Fax |
|
| Email |
jagadeshweta.sj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita S Patil |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga,Room no 10,Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km Kanakapura Road, Udayapura P.O, Bengaluru-560082
India
sri sri ayurvedic hospital pg girls hostel bengaluru
Bangalore
KARNATAKA
560082
India |
| Phone |
9742193553 |
| Fax |
|
| Email |
rampursspatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Jagade |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga,Room no 10,Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km Kanakapura Road, Udayapura P.O, Bengaluru-560082
India
sri sri ayurvedic hostel pg girls hostel bengaluru
Bangalore
KARNATAKA
560082
India |
| Phone |
8806918513 |
| Fax |
|
| Email |
jagadeshweta.sj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science and Research Hospital Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Jagade |
| Address |
Sri Sri College Of Ayurvedic Science and Research, Kanakapura
Road, Udayapura P.O,560082 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sri College Of Ayurvedic Science and Research |
Kanakapura Road,Udayapura PO 560082 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Jagade |
Sri Sri College Of Ayurvedic Science and Research Hospital |
Department Of Prasuti
Tantra and Stree Roga,
Room no.10,Kanakapura
Road, Udayapura
PO,Bangalore-560082
Bangalore
KARNATAKA
Bangalore Rural
KARNATAKA |
8806918513
jagadeshweta.sj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Commitee |
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: NA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | yoni pichu | (Procedure Reference: chakradatta , Procedure details: Procedure details: Procedure details: Poorva karma- Patient is asked to empty the bladder. Patient is made to lie down in lithotomy position. Vaginal speculum to be inserted & Yoni Prakshalana with warm water to be done. Pradhana karma- With gloved hands, durvadhyam Taila Pichu is to be inserted in the vaginal canal. Paschat karma- Patient is instructed to retain the Pichu for 5 to 6 hours or till the urge to micturition .Instruction to be given to the patient for removing the Pichu. Same procedure should be continued for a period of 7 days.))
(1) Medicine Name: durvadhyam, Reference: chakradatta , Route: Vaginal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | yoni pichu | (Procedure Reference: chakradatta , Procedure details: Procedure details: Poorva karma- Patient is asked to empty the bladder. Patient is made to lie down in lithotomy position. Vaginal speculum to be inserted & Yoni Prakshalana with warm water to be done. Pradhana karma- With gloved hands, Jatyadi Taila Pichu is to be inserted in the vaginal canal. Paschat karma- Patient is instructed to retain the Pichu for 5 to 6 hours or till the urge to micturition .Instruction to be given to the patient for removing the Pichu. Same procedure should be continued for a period of 7 days.)
(1) Medicine Name: jatyadi taila , Reference: ayurvedic formulation of india , Route: Vaginal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects with age group of 21-45 years.
2.Subjects who are married.
3.Subjects who is with classical symptoms of 4.cervical erosion.
5.Subjects having contact bleeding.
6.Subjects with Hb more than 10g/dl.
Subjects willing to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who are Pregnant .
2.Subject having cervical polyps.
3.Subject with known case of pre malignant lesion, Carcinoma of cervix.
4.Subject with known case STD and HIV.
5.Subjects with known case of severe systemic illness.
6.Subjects with known case of diabetes mellitus.
7.Subjects with known case of congenital malformations of cervix.
8.Subject who are undergoing hormonal treatment and with intrauterine contraceptive device.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant decrease in the sign and symptoms of cervical erosion |
Pre assessment on 0th day
1st assessment On 8th day
Follow up without treatment – On 15th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in- depth analysed data on the
different aspect of the disease.
Generation of data on possible unexpected drug
reaction. |
pre Assessment-0th day
1st Assessment- on 8th day
follow up without treatment-on 15th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2025 |
| 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="1"
Months="6"
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
|
Cervical
erosion is characterized by the replacement of the squamous epithelium of the
ectocervix with columnar epithelium, which is continuous with the endocervix. The
condition is usually asymptomatic, but patients may present with
mucoid/mucopurulent, offensive, and irritant vaginal discharge, which may be
even blood-stained due to premenstrual congestion associated with backache and
pelvic pain. Chikisa
Siddhanta
(treatment
principles) of Vrana
can be used to treat cervical erosion. Jatyadi Taila and
Durvadyam Taila are
two formulations mentioned in Sharangadhara Madhyama Khanda and
Chakradatta
respectively,
which
are having Vranahara
property in Phalashruti. Hence
these
drugs are used to reduce the symptoms of cervical erosion |