| CTRI Number |
CTRI/2024/08/072396 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| 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
|
A Study To Show The Effect Of Sarivadi Kwath And Triphala Kwath Dhawan In Yoni Roga ( Candida Vaginitis) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Sarivadi Kwatha and Triphala Kwatha Yoni Prakshalana in Kaphaja Yoni Vyapad wsr to Candida Vaginitis |
| 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 Pooja Gunshekhar Tambake |
| Designation |
PG Scholar |
| Affiliation |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar Terdal 587315 Karnataka India
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar Terdal 587315 Karnataka India
Bagalkot
KARNATAKA
587315
India |
| Phone |
9067281581 |
| Fax |
|
| Email |
poojaainapure5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parashuram K Rawal |
| Designation |
Professor And HOD |
| Affiliation |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar Terdal 587315 Karnataka India
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar Terdal 587315 Karnataka India
Bagalkot
KARNATAKA
587315
India |
| Phone |
9880976151 |
| Fax |
|
| Email |
Chaitanya.rawal5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parashuram K Rawal |
| Designation |
Professor And HOD |
| Affiliation |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar Terdal 587315 Karnataka India
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar Terdal 587315 Karnataka India
Bagalkot
KARNATAKA
587315
India |
| Phone |
9880976151 |
| Fax |
|
| Email |
Chaitanya.rawal5@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Gunshekhar Tambake |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar Terdal 587315 Karnataka India
|
| Type of Sponsor |
Other [] |
|
|
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 pooja tambake |
Padma Ayurvedic Hospital and Research Centre Terdal |
OPD and IPD of Department of Prasuti Tantra and Stree Roga Terdal 587315
Bagalkot
KARNATAKA |
9067281581
poojaainapure5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTAMC 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: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Charak Samhita Chikitsathan, Procedure details: it is ayurvedic procedure washing of vaginal area by using medicated kwatha or medicated oils or swarasa)
(1) Medicine Name: Triphala kwath, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1(ml), Frequency: sos, Duration: 07 Days | | 2 | Comparator Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Charak Samhita Chikitsathan,, Procedure details: it is ayurvedic procedure washing of vaginal area by using medicated kwatha or medicated oils or swarasa))
(1) Medicine Name: Sarivadi kwath, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 1(ml), Frequency: sos, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient with Pratyatma Lakshanas of kaphaja yoni vyapad and tested positive for presence of candida albicans through wet mount test
Married women
Subject willing to sign the consent form
|
|
| ExclusionCriteria |
| Details |
Patient in Menstrual bleeding phase
Diagnosed case of PCOD PID
KCO Malignancy thyroid and parathyroid diseases
Patient with systemic disorder like DM Severe Anaemia HTN TB HIV HbSAg
Pregnancy
Cervical erosion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of trial drug over kaphaj yonivyapad (candida vaginitis) assessed by the assesement parameters |
Total study duration 30days
Study visits 0th day 15th day and 30th day
Duration of drug intervention 7 days after bleeding phase
Follow up 15th day 30th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study about Candida Vaginitis Kaphaja Yonivyapad in detail |
7th day 15th day 30th day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="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
|
Candida vaginitis is a common reproductive age infection and secondary to fungal infection with itching in vagina and unctuous discharges candida vaginitis is responsible for about 1/3rd of cases In Ayurveda it comes under kaphaja yonivyapad condition. Objectives of study is the effect of Sarivadi Kwatha Yoni Prakshalana in Kaphaja Yoni Vyapad w.s.r. to Candida Vaginitis.This is a randomized comparative clinical study. Total 40 patients of kaphaja yonivyapd will be selected and randomly divided into two groups A and B. Group A will be given Sarivadi Kwatha and Group B given Triphala Kwatha.The subjective and objective parameters selected for assessment criteria. Total Study duration will be 30 days and contain 4 visits (0th day, 7th, 15th day,30th day) which includes administration of trial drug for 7 days and post medication follow up on 30th day.After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis of results, conclusion will be drawn. |