| CTRI Number |
CTRI/2022/01/039248 [Registered on: 07/01/2022] Trial Registered Prospectively |
| Last Modified On: |
06/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
NYAGRODHA,PLAKSHA,YASHTIMADHU KWATH YONIDHAWAN IN KAPHAJ
YONIVYAPAD(VAGINAL CANDIDIASIS). |
|
Scientific Title of Study
|
OPEN RANDOMIZED CONTROLLED CLINICAL STUDY OF NYAGRODHA,
PLAKSHA, YASHTIMADHU KWATH YONIDHAWAN IN KAPHAJ
YONIVYAPAD WITH SPECIAL REFERENCE TO VAGINAL CANDIDIASIS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niranjan Ankush Alekar |
| Designation |
PG Scholar Prasutitantra Evum Strirog |
| Affiliation |
Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reaseach Center,Ashta . |
| Address |
Dept Of Strirog Prasutitantra Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reaseach Center,Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8698698577 |
| Fax |
|
| Email |
niranjanalekar1107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Swati Rajan Kamat |
| Designation |
Asso Professor |
| Affiliation |
Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reaseach Center,Ashta . |
| Address |
Dept Of Strirog Prasutitantra Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reaseach Center,Ashta Tal-Walwa Dist-Sangli
Dept Of Strirog Prasutitantra Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reaseach Center,Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8983345847 |
| Fax |
|
| Email |
drswatikamat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Rajan Kamat |
| Designation |
Reader |
| Affiliation |
Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reaseach Center,Ashta . |
| Address |
Dept Of Strirog Prasutitantra Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reaseach Center,Ashta Tal-Walwa Dist-Sangli
Dept Of Strirog Prasutitantra Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reaseach Center,Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8983345847 |
| Fax |
|
| Email |
drswatikamat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon.Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
HonShri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
| Address |
Vidyanagar,Ashta Tal-Walwa Dist-Sangli Pincode-416301 |
| 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 |
| Niranjan Ankush Alekar |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
Dept Of Strirog Prasuti tantra, OPD no (9),Dhanvantari Hospital,
Vidyanagar,Ashta Tal-Walwa Dist-Sangli Pincode-416301
Sangli
MAHARASHTRA |
8698698577
niranjanalekar1107@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: N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Dhanashri Mahajan.A Critical review on sthanik chikitsa adopted in stree roga.international journal of ayurveda and alternative medicine 2014, Procedure details: 1.Nyagrodh,Plaksha,Yashtimadhu Churn for kwath preparation reference on Sushrut samhita from nyagrodhadi gana.
2.kwath formation according to sharangdhar samhita referance.
3. Procedure-
Proper aseptic measures should be ensured before starting the procedure.
Patient given lithotomy position.
By using douch vaginal apparatus sterile rubber catheter is inserted in vagina (prathamavarta).
Enema pot filled with kwath is kept at 5feet distance with luck warm kwath vagina is washed out.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 18 to 50 years married female patients.
2. Patient having complaints of abnormal Yonigata shweta
strava, Yonikandu, Yonigata vedana.
3. Patients selection of vaginal candidiasis will be confirmed after
doing KOH Test. |
|
| ExclusionCriteria |
| Details |
1. Unmarried female patients.
2. Per vaginal white discharge due to other pathological conditions
like :
a) Cervical or uterine malignancy.
b) Pregnant patient.
c) Systemic Diseases like HTN, DM.
d) Infections like HIV.
3. Patient having menstrual period.
4. Sexually Transmitted diseases.
5. Puerperium.
6. Cervical Erosions.
7. Cervical polyp. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
REDUCTION IN SYMPTOMS OF KAPHAJ YONIVYAPAD BY NYAGRODHA,
PLAKSHA, YASHTIMADHU KWATH YONIDHAWAN. |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Increasing local immunity and
prevent recurrence Of Kaphaj YoniVyapad After giving Nyagrodha,Plaksha,Yashtimadhu kwath Yonidhawan |
4week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
11/01/2022 |
| 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
|
I am Niranjan Ankush Alekar PG Scholar Of Prasutitantra evum Streerog trying to evalute the efficacy of Nyagrodha,Plaksha,Yashtimadhu Kwath Yonidhawan In Kaphaj Yonivyapad With Special Reference To Vaginal Candidiasis. kashay of nyagrodha,plksha,yashtimadhu is effective in yonigat shweta stav,yonikandu and yonivedana study will reveal this kashay is effective in kaphaj yonvyapad or not. |