| CTRI Number |
CTRI/2016/02/006606 [Registered on: 03/02/2016] Trial Registered Prospectively |
| Last Modified On: |
24/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [PhD thesis] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Nimbadi yonivarti and Vidangadi lauha in vaginal discharge |
|
Scientific Title of Study
|
A randomized clinical trial of swetapradara w.s.r. to infective vaginal discharge with Nimbadi yonivarti and Vidangadi lauha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krutika Chaudhari |
| Designation |
PhD. Student |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Stree Roga and Prasooti Tantra, Institute for Postgraduate Teaching and Research in Ayurveda, GAU GUJARAT, India
Department of Stree Roga and Prasooti Tantra, Institute for Postgraduate Teaching and Research in Ayurveda, GAU GUJARAT, India
Jamnagar
GUJARAT
361008
India |
| Phone |
9429012309 |
| Fax |
|
| Email |
chaudhari_krutika88@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof L P dei |
| Designation |
Professor and HOD of Stree Roga and Prasooti tantra Department |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar
GUJARAT
India
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar
GUJARAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
deikaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof L P dei |
| Designation |
Professor and HOD of Stree Roga and Prasooti tantra Department |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar
GUJARAT
India
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar
GUJARAT
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
deikaxmipriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PHARMACY OF GUJARAT AYURVED UNIVERSITY JAMNAGAR |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATE TRAINING AND RESEARCH IN AYURVEDA |
| Address |
GUJARAT AYURVED UNIVERSITY,JAMNAGAR,GUJARAT. |
| 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 Krutika Chaudhari |
Institute for postgraduate teaching and research in ayurveda |
OPD no 8 Dept of SRPT IPGT RA Jamnagar GUJARAT
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9429012309
chaudhari_krutika88@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee institute for post graduate teaching and research in ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, Patients who suffering from infective vaginal discharge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A:Nimbadi Yonivarti |
1 Vaginal suppository(Nimbadi Yonivarti) of 3gm once a day at bed time for 15 days |
| Comparator Agent |
Group B:Nimbadi Yonivarti and
Vidangadi Lauha tablet
|
1 Vaginal suppository(Nimbadi Yonivarti) of 3gm once a day at bed time and 2 tablet of Vidangadi Lauha(each of 500mg) bd after meal for 15 day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Married women.
The patients having clinical signs and symptoms of Swetapradara i.e. features of white discharge with itching / any abnormal smell/swelling ,redness.
Detection of pathogen by wet vaginal smear examination including any featrures either one/ two/three/all.
Hemoglobin greater than 7gms% |
|
| ExclusionCriteria |
| Details |
Unmarried women
Age below 20 years and above 50 years
pregnant women
patients suffering from tuberculosis, HIV, VDRL, Genital malignancy and Congenital and any other organic pathologies of reproductive tract
Hemoglobin less than 7 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effect of Nimbadi Yonivarti and Nimbadi Yonivarti with Vidangadi lauha orally in the management of Swetapradara w.s.r. infective vaginal discharge |
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prevent recurrence rate of infective vaginal discharge |
45 days |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "117"
Final Enrollment numbers achieved (India)="117" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2016 |
| Date of Study Completion (India) |
29/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
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
|
This study is on infective vaginal discharge. Drugs used for this study are Nimbadi Yonivarti and Vidangadi lauha Tablet. In Group A, Nimbadi Yonivarti is given once a day per vaginally at bed time for 15 days. In Group B, NImbadi Yonivarti is given once a day per vaginally at bed time and two tablet (500mg each) of Vidangadi lauha are given orally two times a day after meal for 15 days.Followup is taken for 1 month with the interval of 15 days. Before and after treatment , wet vaginal study, gram stain,10% KOH preparation, Vaginal discharge for culture(Aerobic and fungal) and vaginal pH are done in each patients for assesment of result
|