| CTRI Number |
CTRI/2024/07/070215 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| 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
|
To evaluate the efficacy of guduchyadi yonivarti in Upaplutha yonivyapath, vulvovaginitis during pregnancy |
|
Scientific Title of Study
|
An Open Label Double Arm Randomised Controlled Clinical Study On Efficacy Of Guduchyadi Yonivarti In Upaplutha Yonivyapath Vulvovaginitis During Pregnancy |
| 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 Ankitha M |
| Designation |
PG Scholar |
| Affiliation |
Sri dharmasthala manjunatheshwara institute of ayurveda and hospital ,Bangalore |
| Address |
Department of prasuti tantra and stri roga OPD No 4,5,6,24,29 Sri dharmasthala manjunatheshwara institute of ayurveda and hospital ,SH17,Anchepalya,Bangalore.
Bangalore
KARNATAKA
560074
India |
| Phone |
8296861526 |
| Fax |
|
| Email |
ankithamanjunath20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anusha M |
| Designation |
Associate professor |
| Affiliation |
Sri dharmasthala manjunatheshwara institute of ayurveda and hospital ,Bangalore |
| Address |
Department of prasuti tantra and stri roga OPD No.5 Shri dharmasthala manjunatheshwara institute of ayurveda and hospital ,SH17,Anchepalya,Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
8105777424 |
| Fax |
|
| Email |
dranusham@sdmayurbangalore.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankitha M |
| Designation |
PG Scholar |
| Affiliation |
Sri dharmasthala manjunatheshwara institute of ayurveda and hospital,Bangalore |
| Address |
Department of prasuti tantra and stri roga OPD No 4,5,6,24,29 Sri dharmasthala manjunatheshwara institute of ayurveda and hospital ,SH17,Anchepalya,Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
8296861526 |
| Fax |
|
| Email |
ankithamanjunath20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of prasuti tantra and stri roga OPD No 4,5,6,24,29 Sri dharmasthala manjunatheshwara institute of ayurveda and hospital ,SH17,Anchepalya,Bangalore. |
|
|
Primary Sponsor
|
| Name |
Dr Ankitha M |
| Address |
Department of prasuti tantra and stri roga OPD No 4,5,6,24,29 Sri dharmasthala manjunatheshwara institute of ayurveda and hospital ,SH17,Anchepalya,Bangalore. |
| 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 Ankitha M |
Sri Dharmasthala manjunatheshwara Institute of Ayurveda and Hospital ,Bangalore |
Department of prasuti tantra and stri roga OPD No 4,5,6,24,29 Sri dharmasthala manjunatheshwara institute of ayurveda and hospital ,SH17,Anchepalya,Bangalore.
Bangalore
KARNATAKA |
8296861526
ankithamanjunath20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititional Ethics committee,Sri dharmasthala manjunatheshwara institute of ayurveda and hospital, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O235||Infections of the genital tract inpregnancy. Ayurveda Condition: UPAPLUTA/APLUTA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi yonivarti, Reference: Bhaishajya ratnavali, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 4(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Clindamycin and clotrimazole vaginal suppository | Clindamycin -100 mg
Clotrimazole-100 mg
OD for 7 days
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Primi and multi gravida
2.Second and third trimester
3.Subjects with lakshanas of upapluta yonivyapad – yoni srava , yonikandu
4.Subjects with age group of 20 to 40 years
|
|
| ExclusionCriteria |
| Details |
1.Subjects with age less than 20 years and more than 40 years
2.First trimester
3.Subjects suffering from systemic illness like Diabetes milletus , hypertension ,UTI
4.Subjects suffering from Sexually Transmitted Disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in signs and symptoms of Upapluta yonivyapath, vulvovaginitis during pregnancy based on grading |
Baseline, 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved quality of life and prevent recurrence in patients diagnosed with Upapluta yonivyapath, vulvovaginitis during pregnancy based on grading |
Baseline, 15 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
20/07/2024 |
| 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)
|
Open to Recruitment |
| 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
|
An open label double arm randomised controlled clinical study on efficacy of guduchyadi yonivarti in upapluta yonivyapath ,vulvovaginitis during pregnancy of age group 20 - 40 years for period of 7 days floowed by 1 week of follow up .During the study period 32 pregnant patients will be recruited and divided into two groups , Group A (Control drug ) and Group B ( Trial drug ) with 16 patients in each group .Group A will recieve Clingen and clotrimazole suppository and Group B will recieve Guduchyadi yonivarti for 7 days .Clinical assessment will be done for both subjective and objective criteria on 8 th day (o day ,8 th day and 15 day ) and statistical analysis will be done by considering the data of Day 0 (BT) and Day 15 (AT) |