| CTRI Number |
CTRI/2018/03/012320 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/09/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
white dischage during pregnancy and its treatment with ayurveda |
|
Scientific Title of Study
|
Further study on upapluta yonivyapada wsr to vulvovaginitis during pregnancy and its management with panchavalkaladi formulation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priti singh verma |
| Designation |
PG scholar |
| Affiliation |
Institute For PostGraduate teaching and Research in Ayurveda |
| Address |
Department of stree and prasooti tantra Institute for postgraduate teaching
and research in ayurveda Gujarat Ayurved University
Jamnagar
GUJARAT
361008
India
Department of stree and prasooti tantra Institute for postgraduate teaching
and research in ayurveda Gujarat Ayurved University
Jamnagar pglh room 43
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
09377020506 |
| Fax |
|
| Email |
pritigarg19@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S B Donga |
| Designation |
Reader |
| Affiliation |
Institute For PostGraduate teaching and Research in Ayurveda |
| Address |
Department of stree and prasooti tantra Institute for postgraduate teaching
and research in ayurveda Gujarat Ayurved University Jamnagar
GUJARAT
361008
India
Department of stree and prasooti tantra Institute for postgraduate teaching
and research in ayurveda Gujarat Ayurved University
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
09825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L P Dei |
| Designation |
Associate Professor and Head |
| Affiliation |
Institute For PostGraduate teaching and Research in Ayurveda |
| Address |
Department of stree and prasooti tantra Institute for postgraduate teaching
and research in ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India
Department of stree and prasooti tantra Institute for postgraduate teaching
and research in ayurveda Gujarat Ayurved University Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
09228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of postgraduate teaching and research in ayurved Gujarat Ayurved University Jamnagar
361008 |
|
|
Primary Sponsor
|
| Name |
Institute of postgraduate teaching and research in ayurved |
| Address |
Gujarat Ayurved University Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 priti singh verma |
Institute of post graduate teaching and research in ayurveda |
OPD no 19 Dept of stree and prasooti tantra
jamnagar
GUJARAT
Jamnagar
GUJARAT |
09377020506
drpritigarg19@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee post graduate teaching and research in ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
upapluta yonivyapad (white discharg during pregnancy), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
clotrimazol 100mg clindamycin 100mg |
clotrimazol 100mg clindamycin 100mg 1suppository localy daily for 14 days |
| Intervention |
panchvalkaladi ointment and panchvalkaladi Varti for 14 days |
Panchvalkaladi ointment 10gm localy twice daily and panchvalkaladi Varti 1 gm localy twice daily for 14 days |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
After completion of first Trimester of pregnancy
Age 19 to 40 years with different parity.
White discharge present during examination.
Inflammation present in vulva and vagina.
Pathogens present in wet slide study and vaginal swab culture.
|
|
| ExclusionCriteria |
| Details |
Age below 19 yrs or above 40 yrs with non specific vulvovaginitis
Hypersensitivity to drug and inability to conform the protocol
Women with severe physical illness, any organic pathology hepatic cardiac renal disease and any acute infection of any system
Women suffering from any systemic disease like Diabetes TB STD and HIV
First trimester of pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of signs symptoms
Return of pH towards normal value
Absence of pathogen in wet slide study
Vaginal swab culture becomes sterile
Observation of absence of clinical features
|
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement of itching and redness in vagina |
14 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
22/11/2011 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is randomised control clinical study to evaluate efficacy of Panchavalkaladi Varti in group A and Panchavalkaladi ointment in group B, group C has control group of Clotrimazole 100 mg Clindamycin100 mg vaginal suppository.The primary outcome measures the changes in subsidence of clinical signs and symptoms measured at baseline. Absence of pathogen in wet slide study,Vaginal swab culture becomes sterile and absence of recurrence during follow up. The study period is for 14 days and Panchavalkaladi Varti will be given in dosage of 1gm 1tab twice daily per vaginally, Panchavalkaladi ointment will be given in dosage of 5gm twice daily per vaginally and Clotrimazole 100 mg Clindamycin100 mg vaginal suppository will be given once daily.
|