| CTRI Number |
CTRI/2011/10/002075 [Registered on: 18/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
14/10/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To collect the data on prevalence and type of chronic venous disease in India |
|
Scientific Title of Study
|
Prospective, observational, epidemiological cohort study to collect data (for e.g. patient demographics, medical history, disease presentation, investigations, CEAP classification, past & present treatment, etc.) about chronic venous disease in India. |
| Trial Acronym |
NVDR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SER/2010/EPI-SURVEY/001 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Saravanan |
| Designation |
Consultant Vascular & Transplant Surgeon |
| Affiliation |
Madras Medical Mission |
| Address |
CTC,Madras Mediacl Mission,No 4 A, Dr J.J Nagar,Mogappair
Chennai
TAMIL NADU
600 037
India |
| Phone |
09840040644 |
| Fax |
|
| Email |
drssmmm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sammeer Addhikari |
| Designation |
Clinical Research Project Manager |
| Affiliation |
Serdia Pharmaceuticals India Pvt Ltd |
| Address |
Serdia House,Off Dr S.S Rao Road,Parel
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
02224162727 |
| Fax |
02224162735 |
| Email |
sammeer.addhikari@in.netgrs.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjusha Rajarshri |
| Designation |
Head- Clinical Research and Regulatory Affairs |
| Affiliation |
Serdia Pharmaceuticals India Pvt Ltd |
| Address |
Serdia House,Off Dr S.S Rao Road,Parel
Mumbai
MAHARASHTRA
400 012
India |
| Phone |
02224162727 |
| Fax |
|
| Email |
manjusha.rajarshri@in.netgrs.com |
|
|
Source of Monetary or Material Support
|
| Serdia Pharmaceuticals India Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Serdia Pharmaceuticals india Pvt Ltd |
| Address |
Serdia House ,off Dr S.S Rao Road,Parel ,Mumbai -400 012 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Saravanan |
Madras Medical Mission Hospital |
CT, Madras Medical Mission, No 4 A , Dr J.J Nagar,Mogappair
Chennai
TAMIL NADU |
09840040644
drssmmm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Madras Mediacl Mission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic venous disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
chronic venous disease patients in India. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to collect data (for e.g. patient demographics, medical history, disease presentation, investigations, CEAP classification, past & present treatment, etc.) about chronic venous disease in India. |
Not defined |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
18/08/2011 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open-label, prospective, observational, epidemiological cohort study to collect data (for e.g. patient demographics, medical history, disease presentation, investigations, CEAP classification, past & present treatment, etc.) about chronic venous disease in India. |