| CTRI Number |
CTRI/2020/06/025911 [Registered on: 16/06/2020] Trial Registered Prospectively |
| Last Modified On: |
07/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To observe the relation between causative factor of kaphaj yonivyapad with present era. |
|
Scientific Title of Study
|
An obesrvational study to correlate the causative factors of kaphaj yonivyapad mentioned in Bruhatrayi and Laghutrayi with present era. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma Rajkumar katakdhond |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Aurved and Research Centre. |
| Address |
Ayurved Rugnalaya and Multispeciality Hospital,Sector-27,Akurdi,Nigadi,pune-411044
College of Ayurved and Research Centre,Sector-25,Akurdi,Nigadi,pune-411044.
Pune
MAHARASHTRA
411044
India |
| Phone |
9552669272 |
| Fax |
|
| Email |
reshma28.rk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep S Khandalikar |
| Designation |
Associate Proffesor |
| Affiliation |
PDEAS College of Aurved and Research Centre. |
| Address |
Ayurved Rugnalaya and Multispeciality Hospital,Sector-27,Akurdi,Nigadi,pune-411044
College of Ayurved and Research Centre,Sector-25,Akurdi,Nigadi,pune-411044.
Pune
MAHARASHTRA
411044
India |
| Phone |
9860355409 |
| Fax |
|
| Email |
sandeep.khandalikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reshma Rajkumar katakdhond |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Aurved and Research Centre. |
| Address |
Ayurved Rugnalaya and Multispeciality Hospital,Sector-27,Akurdi,Nigadi,pune-411044
College of Ayurved and Research Centre,Sector-25,Akurdi,Nigadi,pune-411044.
Pune
MAHARASHTRA
411044
India |
| Phone |
9552669272 |
| Fax |
|
| Email |
reshma28.rk@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Ayurved and Research Centre,nigadi,pune 411044 |
|
|
Primary Sponsor
|
| Name |
College of Ayurved and Research Centre |
| Address |
Sector 25,Pradhikaran,Nigadi,pune 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Reshma Rajkumar Katakdhond |
PDEAS College of Ayurved and Research Centre |
Ayurved rugnalaya and multispeciatlity hospital,Streerog Evam prasuti tantra department,opd no 119,ground floor,sector27,pradhikaran, nigadi,pune411044,
Maharashtra.
Pune
MAHARASHTRA |
9552669272
reshma28.rk@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
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N899||Noninflammatory disorder of vagina, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patiets with symptom of Kaphaj Yonivyapad
2.Both sexually active and inactive patients |
|
| ExclusionCriteria |
| Details |
1.Patients with ring pessaries
2.Patients with major illness like heart disease,respiratory disease,HIV,TB,cancer,Endocrinal disorders etc.
3.Patients with physiological white discharge.
4.Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the symptoms and causative factors of kaphaj yonivyapad from Bruhatrayi and Laghutrayi amd compare it with present era. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find correlation between the symptoms and causative factors of kaphaj yonivyapad with the factors present in todys Era. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Prevalence rate of Kaphaj Yonivyapad has increased because of sedentary lifestyle,junk food,lack of exercise,psychological stress are the reason of increasing yonirogas in females.A woman is not able to follow the rules of Rajswala paricharya described by acharyas in samhita .As a result,a women are prone to various yonivikaras which are biggest challenge to treat completely in front of medical professionals. in Previous work done on Kaphaj Yonivyapad much emphasis was given on the treatment part rather than dietary causes .Hence ,some well defined causative factors can help in early detection of the disease from Preventive aspect and it will help in proper management of the disease through ayurvedic perspective. |