| CTRI Number |
CTRI/2025/04/085841 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study of efficacy of Bruhatiphal,Haridra,Daruharidra kwath application in vaginal cavity in Upapluta Yonivyapada(Vaginal candidiasis in pregnancy) |
|
Scientific Title of Study
|
A Randomized, Controlled, Clinical study of application of Bruhatiphal,Daruharidra,Haridra kwath for vaginal painting in Upapluta Yonivyapada with special reference to vaginal candidiasis in pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVarsha Shantilal Shelake |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Department of Prasuti Tantra and Streerog, Government Ayurved College and
Hospital,Nanded, Vazirabad, Nanded. MAHARASHTRA 431601, india
Nanded
MAHARASHTRA
431601
India |
| Phone |
7774920984 |
| Fax |
|
| Email |
varshashelake74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVarsha Shantilal Shelake |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Department of Prasuti Tantra and Streerog, Government Ayurved College and
Hospital,Nanded, Vazirabad, Nanded. MAHARASHTRA 431601, india
Nanded
MAHARASHTRA
431601
India |
| Phone |
7774920984 |
| Fax |
|
| Email |
varshashelake74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManjusha Rupchand Meshram |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurved College, Nanded |
| Address |
Department of Prasuti Tantra and Streerog,Government Ayurved College and Hospital, Nanded, Vazirabad, Nanded. MAHARASHTRA 431601, india
Nanded
MAHARASHTRA
431601
India |
| Phone |
9657017483 |
| Fax |
|
| Email |
drmanjushameshram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasuti Tantra and Streerog,Government Ayurved College and Hospital, Nanded ,vazirabad,Nanded.431601, Maharashtra , india. |
|
|
Primary Sponsor
|
| Name |
Dr.Varsha Shantilal Shelake |
| Address |
Department of Prasuti Tantra and Streerog,Government Ayurved College and Hospital, Nanded, Vazirabad, Nanded. MAHARASHTRA 431601, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrVarsha Shantilal Shelake |
Government Ayurved College and Hospital Nanded |
Department of Prasuti Tantra and Streerog, ward number 69,Government Ayurved College and Hospital, Nanded, Vazirabad, Nanded. MAHARASHTRA 431601, india
Nanded
MAHARASHTRA |
7774920984
varshashelake74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee, Government Ayurved College, Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: UPAPLUTA/APLUTA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Vaginal painting | (Procedure Reference: Sushruta Uttartantra 38/27, Procedure details: Under all aseptic precautions vaginal painting will be carried out with the help of Sims vaginal speculum & AV retractor, vaginal wall will be retracted gently.
Average size guaze swab will be soaked in freshly prepared lukewarm trial drug kwatha
With the help of sponge holder wiping of vaginal canal with 3-4 different swabs soaked in 50 mlKwatha will be done as painting twice a day for 5 days)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Clotrimazole 100 mg vaginal pessary | Clotrimazole 100 mg vaginal pessary kept in vaginal cavity at bed time for 5 days.
Reference DC Dutta,7 edition,135 page number |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Clinically diagnosed cases of Upapluta Yonivyapada with vaginal candidiasis in pregnancy having symptoms of
White thick curdy vaginal discharge
Vaginal itching
Pregnat patient of 20 weeks to 36 weeks |
|
| ExclusionCriteria |
| Details |
First trimester pregnant patient
Premature rupture of membrane
Premature labour
Placenta previa
Cervical malignancy
Other systemic disorder like Diabetes, Tuberculosis,HIV, Sexually Transmitted diseases |
|
|
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 |
| Efficacy of Bruhatiphal, Daruharidra, Haridra kwath vaginal painting in Upapluta Yonivyapada and assessment of releived symptoms like wthite thick curdy vaginal discharge, vaginal itching |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
07/05/2025 |
| 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="2"
Months="0"
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
|
This study is a Randomized, Controlled, Clinical study of application of Bruhatiphal, Daruharidra, Haridra kwath for vaginal painting in Upapluta Yonivyapada with special reference to vaginal candidiasis in pregnancy.Vaginal painting twice a day for 5 days and follow up on 0 ,6th,15th day.This study will be carried out in 2 years of PG course. |