| CTRI Number |
CTRI/2018/05/013875 [Registered on: 14/05/2018] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
use of palasha and pipar in white discharge |
|
Scientific Title of Study
|
A Comparative Clinical Study of Palashapushpa and Plaksha twak On its Sangrahi Karma w. s. r. to Shwetapradara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema H Kathavadiya |
| Designation |
MD Scholar second year |
| Affiliation |
Government Ayurved college, Vadodara. |
| Address |
Post graduate department of Dravyaguna,Government Ayurved College, Dhanvantari marga, Ajwa road, Panigate, Vadodara,390019
Gujarat,India
Vadodara
GUJARAT
390019
India |
| Phone |
9998635949 |
| Fax |
|
| Email |
Seemavyas231@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hariom N Gupta |
| Designation |
Associate professor |
| Affiliation |
Government Ayurved college, Vadodara. |
| Address |
Post graduate department of Dravyaguna,Government Ayurved College, Dhanvantari marga, Ajwa road, Panigate, Vadodara,390019
Gujarat,India
Vadodara
GUJARAT
390019
India |
| Phone |
9426564441 |
| Fax |
|
| Email |
ayurdrhariom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Parmar |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurved college, Vadodara. |
| Address |
Post graduate department of Dravyaguna,Government Ayurved College, Dhanvantari marga, Ajwa road, Panigate, Vadodara,390019
Gujarat,India
Vadodara
GUJARAT
390019
India |
| Phone |
9558819463 |
| Fax |
|
| Email |
Nehaa.parmarr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved college and Hospital, Vadodara |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
Government Ayurved Hospital, Dhanvantari Marga, Ajwa road, Panigate, Vadodara-390019 |
| 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 Seema H Kathavadiya |
OPD AND IPD Dravyaguna Department, Government Ayurved Hospital , Vadodara |
PG 2 OPD,
Post graduate Dept. of Dravyaguna,
Vadodara
GUJARAT |
9998635949
Seemavyas231@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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, with Symptoms of leucorrhoea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Palasha flower(Butea monosperma (Lam.) Kuntze) |
3 gms churna with honey two times before food for 4 weeks |
| Comparator Agent |
Plaksha bark(Ficus lacor Buch.-Ham) |
3 gms churna with honey two times before food for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 18 to 50 years of female patients.
2. Patient having complaints of Yonigata Shwetasrava.
3. Patients will be selected without consideration of bar of race and religion.
|
|
| ExclusionCriteria |
| Details |
1. Per vaginal white discharge due to other pathological conditions like-
• Cervical or uterine malignancy
• Pathological conditions like cervicitis, vaginitis, cervical erosion, PID.
2. Pregnant patient.
3. Uncontrolled systemic Diseases like HTN, DM.
4. Local and systemic infections like HIV, STD.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the clinical symptoms of leucorrhoea |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2018 |
| Date of Study Completion (India) |
10/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The Study is a Randomized clinical trial to evaluate the Sangrahi karma of Palasha pushpa churna and Plaksha twak churna on Shwetapradara (leucorrhoea). Total 30 patients will be enrolled in present study. Selected patients will be divided in 2 group on the basis of computer generated randomization. In this study Palasha pushpa churna will be given in dose of 3 gm two times before food with honey for 4 weeks and Plaksha twak churna will be given in dose of 3 gm two times before food with honey for 4 weeks. Folllow up will be 2 weeks.The clinical data obtained will be summarized at the end of the study. Conclusion will be made after the statistical analysis of the data. Stastically Palashapushpa churna has significantaly result than Plaksha twak churna. |