| CTRI Number |
CTRI/2024/03/063704 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Bruhtyadi Choorna Yonidhoopan in Yonikandu w.s.r. Vulvovaginal candidiasis in comparison with Candid ointment |
|
Scientific Title of Study
|
A Randomised Controlled study to assess the effectiveness of Bruhtyadi Choorna Yonidhoopan in comparison with Candid ointment in Yonikandu in Kaphaj Yonivyapad w.s.r. Vulvovaginal Candidiasis. |
| 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 Bhagyashri Satish Salunkhe |
| Designation |
PG Scholar |
| Affiliation |
Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Kharghar |
| Address |
Opd No.6, Prasutitantra and Streeroga Department, Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai
3rd floor, Prasutitantra and Streeroga Department, Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9657874479 |
| Fax |
|
| Email |
salunkhebhagyshri08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Mehere |
| Designation |
HOD and Professor |
| Affiliation |
Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Kharghar |
| Address |
Opd No.6, Prasutitantra and Streeroga Department, Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai
3rd floor, Prasutitantra and Streeroga Department, Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930940403 |
| Fax |
|
| Email |
seema.mehre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Satish Salunkhe |
| Designation |
PG Scholar |
| Affiliation |
Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Kharghar |
| Address |
Opd No.6, Prasutitantra and Streeroga Department, Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai
3rd floor, Prasutitantra and Streeroga Department, Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9657874479 |
| Fax |
|
| Email |
salunkhebhagyshri08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Bhagyashri Satish Salunkhe |
| Address |
Opd No.6, Prasutitantra and Streeroga Department, Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai |
| 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 |
| Dr Bhagyashri Satish Salunkhe |
Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Kharghar |
Opd No.6, Prasutitantra and Streeroga Department, Dr. G.D.Pol Foundation, YMT Ayurvedic Medical College, Institutional Area,Sector 4 Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
9657874479
salunkhebhagyshri08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B373||Candidiasis of vulva and vagina. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Candid ointment | local application twice in a day for 10 days. | | 2 | Intervention Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: sushrutsamhita uttartantra 38/27, Procedure details: Yonidhoopan 2 times a day for 10 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients under reproductive age group of 25-35 years.
2. Patients complaining of Yonikandu (Vaginal Itching).
3. Womens who are sexually active.
4. Patients with complaints of yonikandu for less than 15 days. |
|
| ExclusionCriteria |
| Details |
1. Patients in menstrual bleeding phase.
2. Patient with Chronic PID.
3. Patient with genital malignancy.
4. Under prolonged use of antibiotics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of Bruhtyadi Choorna Yonidhoopan in Yonikandu in Kaphaj Yonivyapad. |
The study will be conducted for 10 days follow up on day 1,day 7, day 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Establish the best possible comparison of yonikandu with vulvovaginal candidiasis.
2.For Validation of treatment given in ayurvedic granthas. |
The study will be conducted for 10 days follow up on day 1,day 7, day 14 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/03/2024 |
| 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
|
The current study aimed as Evaluation of effect of Bruhtyadi Churna Yonidhoopan in comparison with candid Ointment in Yonikandu in Kaphaj Yonivyapad an Randomised Control study. Total 68 diagnosed patients of Yonikandu are equally divided into two groups, namely experimental and control group. The symptoms are yonikandu, yonipaichilya,yonishitalata etc. Yonidhoopan of bruhtyadi churna used as experimental group will be given for 10days. Candid ointment used as control group will be given for 10 days. Assessment for both will be done at 0th, 7th, 14th, days.Assessment done on the basis of subjective criteria. |