| CTRI Number |
CTRI/2015/05/005747 [Registered on: 05/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
06/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening
Other (Specify) [CURATIVE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dhatakyadi Varti-An Advance Therapy for Vulvovaginitis During Pregnancy |
|
Scientific Title of Study
|
“A CLINICAL STUDY ON UPAPLUTA YONIVYAPAD w.s.r. TO VULVOVAGINITIS DURING PREGNANCY & ITS MANAGEMENT WITH DHATAKYADI VARTI†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRNilofar Shaikh |
| Designation |
PG SCHOLAR |
| Affiliation |
IPGT & RA |
| Address |
26,Aashiyana Park,
opp.Vaijanath Mahadev,
Mahemdabad.
Dist-Kheda
IPGT RA
JAMNAGAR
GUJARAT
Jamnagar
GUJARAT
387130
India |
| Phone |
9638508994 |
| Fax |
|
| Email |
shaikhnilofar12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHILPA DONGA |
| Designation |
ASSOCIATE PROF. |
| Affiliation |
MD (AYU)PHD |
| Address |
IPGT RA
JAMNAGAR
IPGT RA
JAMNAGAR
Jamnagar
GUJARAT
361001
India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHILPA DONGA |
| Designation |
ASSISTANT PROF. |
| Affiliation |
IPGT RA |
| Address |
IPGT RA
JAMNAGAR
IPGT RA
JAMNAGAR
Junagadh
GUJARAT
361001
India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGTRA |
| Address |
IPGT&RA
GAU,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 NILOFAR |
IPGT & RA |
OPD OF STREEROGA & PRASOOTITANTRA N0-8
Jamnagar
GUJARAT |
9638508994
shaikhnilofar12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP-A DHATAKYADI VARTI |
DOSE- 1TAB(3G) PER VAGINALLY AT BED TIME FOR 14 DAYS
|
| Comparator Agent |
GROUP-B CLINGEN VAGINAL SUPPOSITORY |
DOSE- 1 TAB PER VAGINALLY AT BED TIME FOR 14 DAYS |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.The pregnant women with different parity having signs and symptoms of vulvovaginitis.
2.Age 19 to 40years.
3.White discharge present during examination.
4.Inflammation present in vulva and vagina.
5.Pathogens present in wet slide study and vaginal swab culture.
|
|
| ExclusionCriteria |
| Details |
1.Non pregnant Women.
2.Age below 19yrs or above 40 yrs
3.Hypersensitivity to drug and inability to conform the protocol.
4.Women with severe Physical illness, any systemic disease like D.M.,any organic Pathology, Hepatic, Cardiac, Renal disease and any acute Infection of any system,
5.Women suffering from disease like S.T.D.,H.I.V.etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PATIENT GOT SYMPTOMATIC RELIVE IN BOTH GROUPS |
AFTER 14 DAYS OF TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO PREVENT COMPLICATION LIKE PRE MATURE RUPTURE OF MEMBRANE AND PRE TERM LABOR |
TO PREVENT COMPLICATION LIKE PRE MATURE RUPTURE OF MEMBRANE AND PRE TERM LABOR |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/01/2014 |
| Date of Study Completion (India) |
11/11/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
VULVOVAGINITIS IS THE PROBLEM OF PREGNANT WOMEN THAT CHALLENGES THE OBSTETRICIAN TODAY.ANY INFECTION OF BIRTH CANAL MAY LEAD PREMATURE RUPTURE OF MEMBRANE,PRE TERM DELIVERY ETC.TREATMENT MODALITY IN ALLOPATHIC MEDICINE INCLUDES ANTI FUNGAL,ANTI BACTERIAL DRUGS .BUT ALL HAVE UNSATISFACTORY RESULTS AND THEY ALSO HAVE SOME SIDE EFFECTS LIKE LOCAL BURNING SENSATION ,HYPER SENSITIVITY ETC.SO,THERE IS A GREAT SCOPE OF RESEARCH TO FIND OUT SAFE,POTENT,EFFECTIVE AND LESS COSTLY REMEDY OF AAYURVEDA FOR MANAGEMENT OF VULVOVAGINITIS DURING PREGNANCY.VARTI KALPANA IS CONVENIENT FOR PATIENT TO ADMINISTER BY OWN SELF AND NO NEED OF ANY PRECAUTION SO VARTI KAlPANA WAS SELECTED FOR STUDY |