| CTRI Number |
CTRI/2024/07/071316 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| 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
|
Clinical study to see the effect of eladi choorna by oral route in white discharge in females |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Study The Effect Of Eladi Choorna Orally In Kaphaj Yonivyapad With Special Reference To 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 Riddhi Vijay Kadav |
| Designation |
PG student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti tantra avum Streeroga
SMBT Ayurved College and Hospital
Dhamangaon Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9820311379 |
| Fax |
|
| Email |
riddhikadav1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer S Gholap |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti tantra avum Streeroga
SMBT Ayurved College and Hospital
Dhamangaon Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9820304881 |
| Fax |
|
| Email |
drsameer.gholap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riddhi Vijay Kadav |
| Designation |
PG student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Prasuti tantra avum Streeroga
SMBT Ayurved College and Hospital
Dhamangaon Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9820311379 |
| Fax |
|
| Email |
riddhikadav1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prasuti tantra avum Streeroga
SMBT Ayurved College and Hospital
Dhamangaon Nashik Maharashtra India 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Riddhi Vijay Kadav |
| Address |
Department of Prasuti tantra avum Streeroga
SMBT Ayurved College and Hospital
Dhamangaon Nashik Maharashtra India 422403 |
| 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 Riddhi Vijay Kadav |
SMBT Ayurved College and Hospital |
OPD No 4 Department of Prasuti tantra avum Streeroga
Dhamangaon Nashik
Maharashtra
Nashik
MAHARASHTRA |
09820311379
riddhikadav1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N760||Acute vaginitis. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eladi choorna, Reference: Vangsen Streerogadhikar/125, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: yogratnakar, Procedure details: yonidhawan for 1-1.5 min once a day)
(1) Medicine Name: Guduchyadi kwath, Reference: yogratnakar yonivyapad chikitsa, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 7 Days | | 3 | Comparator Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: yogratnakar, Procedure details: yonidhawan for 1 -1.5 min once a day)
(1) Medicine Name: Guduchyadi kwath, Reference: Yogratnakar yonivyapad chikitsa , Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 7 Days | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi choorna , Reference: Charak chikitsa, 30/84, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
married patients having sign and symptoms of kaphaj yonivyapad like Mild vaginal discharge Pruritis vulvae Dull pain |
|
| ExclusionCriteria |
| Details |
Unmarried
Pregnant
Post natal women
known case of diabetes mellitus
Infections like HIV Syphilis Herpes genitalia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 70 |
Baseline, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/08/2024 |
| 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="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 prevalence rate of kaphaj yonivyapad (vulvovaginal candidiasis) is 22.3%. Due to wide use of antifungal agent developing resistance among reproductive female is the main problem. Ayurveda is best alternative for this as it helps to break the pathogenesis of disease. Ayurvedic treatment for management of kaphaj yonivyapad could be safe, effective, readily available, cost effective, non-invasive and without any side effect. For the management of kaphaj yonivyapad both oral and local medication with antifungal properties would have great impact. Chemical content of Eladi choorna shows antifungal properties against Candida albicans. Clinical trial to evaluate efficacy of Eladi choorna orally with local therapy of Yoni Dhawan with guduchyadi kwath would be beneficial to expand knowledge about management alternative. As clinical study has not been assessed in kaphaj yonivyapad so it will help to fill the knowledge gap. Including the married female patient having sign and symptoms of kaphaj yonivyapad like vaginal discharge, pruritis vulvae, dull pain between age group of 18-49 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group).Eladi choorna orally and guduchyadi kwath locally for Yoni Dhawan to group A (Trial group), Pippalyadi choorna orally and guduchyadi kwath for Yoni Dhawan to group B (control group) will be given to patients. Drugs will be purchased from GMC certified pharmacy. Both drugs will be administered for 7 days. All SOP of choorna preparation and Yoni Dhawan procedure will be followed throughout the clinical trial. Observation will be done on 0th and 7th day of treatment. Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observation and result obtained during treatment. Summary will be drawn, and thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn without bias. |