| CTRI Number |
CTRI/2022/09/046079 [Registered on: 30/09/2022] Trial Registered Prospectively |
| Last Modified On: |
12/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of panchavalkal arka in treating patients with white discharge per vagina (vulvo vaginal candidiasis) |
|
Scientific Title of Study
|
Clinical evaluation of the effect of panchavalkal arka in kaphaja yoni vyapat(vulvovaginal candidiasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himanshi Nirwal |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and hospital ,Hassan |
| Address |
Department of Prasuti tantra and Stree roga , Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, B M road ,Thanniruhalla , Hassan , Karnataka , India
Hassan
KARNATAKA
573201
India |
| Phone |
7988482227 |
| Fax |
|
| Email |
himanshi.nirwal.nh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri bhat NV |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital, Hassan |
| Address |
Department of Prasuti tantra and Stree Roga , Sri Dharmasthala Manjutheshwara college of Ayurveda and Hospital , B M road ,Thanniruhalla , Hassan , Karnataka , India
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
|
| Email |
gaya3hassan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Bhat NV |
| Designation |
Professor department of Prasuti tantra and stree roga and stree roga |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital, Hassan |
| Address |
Department of Prasuti tantra and Stree Roga , Sri Dharmasthala Manjutheshwara college of Ayurveda and Hospital , B M road ,Thanniruhalla , Hassan , Karnataka , India
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
|
| Email |
gaya3hassan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,BM road ,Thanniruhalla ,Hassan , Karnataka , India
Phone No-08172256460 , E-mail - sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
SRI DHARMASHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
SRI DHARMASTHALA COLLEGE OF AYURVEDA AND HOSPITAL ,BM ROAD, THANNIRUHALLA, HASAAN 573201 , KARNATAKA ,INDIA
COLLEGE PHONE NO 08172256460
EMAIL- sdmcah@gmail.com |
| Type of Sponsor |
Private 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 |
| Dr Himanshi Nirwal |
SRI DHARMASHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
Department of Prasuti tantra and stree roga,Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, BM Road,Thannirulla, Hassan 573201
Hassan
KARNATAKA |
7988482227
himanshi.nirwal.nh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: KAPHAJA YONI VYAPAT, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: charaka samhita, Procedure details: Patient is advised to wash vulva twice daily )
(1) Medicine Name: panchavalkal arka, Reference: Arka Prakasha, Route: Vaginal, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Married women
2.Subjects fulfilling diagnostic criteria and having local signs and symptoms of kaphaja yoni vyapat as described in texts such as shweta and picchilasrava , yoni kandu and alpa vedana
3.wet vaginal smear postive for candida albicans or microscopically positive for pseudohyphea
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2.subjects positive for HIV,VDRL,HBsAG
3.Systemic diseases like diabets mellitus
4.Subjects on hormonal medications like contraception or regulation of menstruation
5.Subjects who have had anti fungal coverage within 1 month or corticosteriods for less than past 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major symptoms like curdy white discharge, vulval and vaginal itching should be cured. |
Assessment will be done at baseline,follow up on 7th and 15 th day.Vaginal smear will be repeated on 15 th day for result. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other symptoms like backache,pain during coitus should also be reduced. |
15 days |
|
|
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)
|
03/10/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open labeled single arm clinical trial to evaluate the effect of panchavalkal arka in 30 patients with Kaphaja yoni vyapat (vulvo-vaginal candidiasis).The study will be conducted at in/out patient department of prasuti tantra and stree roga in Sri Dharmsthala Manjunatheswara ayurveda hospital Hassan, karnataka.Patients will be advised to wash vulva with 10 ml panchavalkal arka diluted with 100 ml distilled lukewarm water twice a day for 7 days and assessment will be done at baseline,follow up on 7th and 15th day . |