| CTRI Number |
CTRI/2012/08/002902 [Registered on: 22/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
19/01/2022 |
| 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
|
use of nibadi yoga in the treatment of white discharge through vagina. |
|
Scientific Title of Study
|
“FURTHER STUDY ON SWETA PRADAR(VAGINAL DISCHARGE) AND
IT’S MANAGEMENT WITH NIMBADI YOGA .â€
|
| Trial Acronym |
ACID |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| PGT/7-A/ethics/2011-2012/20/2087/42 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
poonam choudhary |
| Designation |
pg scholar |
| Affiliation |
IPGT and RA |
| Address |
dept of stree roga and prasuti tantra IPGT and RA jamnagar gujrat
Jamnagar
GUJARAT
361008
India |
| Phone |
9377871694 |
| Fax |
|
| Email |
poonam.18veena@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L P Dei |
| Designation |
associate proffesor |
| Affiliation |
IPGT and RA |
| Address |
dept of stree roga and prasuti tantra IPGT and RA jamnagar gujrat
Jamnagar
GUJARAT
361008
India |
| Phone |
09228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L P Dei |
| Designation |
associate proffesor |
| Affiliation |
IPGT and RA |
| Address |
dept of stree roga and prasuti tantra IPGT and RA jamnagar gujrat
Jamnagar
GUJARAT
361008
India |
| Phone |
09228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGT and RA |
| Address |
dept of stree roga and prasuti tantra IPGT and RA jamnagar gujrat |
| 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 |
| poonam choudhary |
opd and ipd IPGT and RA |
dept of SRPT IPGT and RA jamnagar
Jamnagar
GUJARAT |
9377871694
poonam.18veena@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee,no.PGT/7-A/ethics/2011-12/2087 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A00-B99||Certain infectious and parasitic diseases. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, vaginal discharge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nimbadi yoga
Yonivarti
|
DOSE-1 tab. of 3gm, root of administration as Vaginal suppository, DURATION
14 days
|
| Comparator Agent |
Vaginal Tablet Clingen |
DOSE-1 tab , root of administration as Vaginal suppository, DURATION 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Married woman.
The patient having clinical sign & symptoms of swetapradar.
The patient having positive causative organism by wet smear test
|
|
| ExclusionCriteria |
| Details |
Unmarried woman
Pregnant woman
Patient suffering from Tuberculosis, Sexually Transmitted Disease like VDRL, HIV, gonorrhea, Genital malignancy and Congenital and any other pathologies of reproductive tract
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| drug standardization |
15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| public interest |
16 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/09/2011 |
| 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="1"
Months="9"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
after completion of project in AYU (An International Quarterly Journal of Research in Ayurveda) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Swetapradara
which occurs due to genital tract infection, has been linked to the occurrence
of tubal factor infertility and ectopic pregnancy.
Every woman may experience white discharge
in their life, but it is not always necessary to take treatment. Only whenever
the woman suffer from some certain pathological conditions the effective
treatment is very essential otherwise it leads to certain complications.
In modern system of medicine
antiprotozoals, antifungal and antibiotic is prescribed as per cause. Due to
antiprotozoals many women experience gastrointestinal upset, headache,
glossitis, stomatitis, dizziness, ataxia and very rarely convulsions. Due to
antifungal gastrointestinal upset like nausea, vomiting, abdominal pain and
diarrhoea, skin rash, headache, dizziness, depression, paraesthesia and
vertigo. Due to antibiotic nausea, vomiting, epigastric pain, skin rash, head
ache, dizziness, and cholestatic jaundice. Mostly drugs are used for local
application, due to this local irritation and burning sensation is common and rarely
hypersensitivity reaction occurs.
So it is great scope of research to find out safe, potent, cost
effective remedy from Ayurveda for the management of Swetapradar. From the
previous work, it is well proved that this health hazard can be well managed
with certain Ayurvedic therapies.
It as been proved by the previous work that Nimbadi Yoga is
effective compound in the management of Swetapradara and to establish this it
should compare with modern medicine. So the further study entitled.
"FURTHER STUDY ON SWETAPRADAR(VAGINAL DISCHARGE) AND ITS
MANAGEMENT WITH NIMBADI YOGA." |