| CTRI Number |
CTRI/2020/07/026645 [Registered on: 17/07/2020] Trial Registered Prospectively |
| Last Modified On: |
17/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Analysing the cancer patients attending Ayothidoss pandithar hospital, National Institute of Siddha. |
|
Scientific Title of Study
|
A Retrospective study on cancer patients attending Ayothidoss pandithar hospital, National Institute of Siddha,Chennai-600047 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sathesh kumar M K |
| Designation |
PG Scholar Third year |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Maruthuvam,
National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
Department of Maruthuvam,
National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
09659327457 |
| Fax |
044-22381314 |
| Email |
drmksathesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Lakshmi Kantham |
| Designation |
Associate professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Maruthuvam,
National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
Department of Maruthuvam,
National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
09659327457 |
| Fax |
044-22381314 |
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sathesh kumar M K |
| Designation |
PG Scholar Third year |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Maruthuvam,
National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
Department of Maruthuvam,
National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
09659327457 |
| Fax |
044-22381314 |
| Email |
drmksathesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
Ayothidoss Pandithar Hospital |
| Address |
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram sanatorium
Chennai 47 |
| 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 |
| Sathesh kumar M K |
National Institute of Siddha,Ayothidoss pandithar hospital |
Room no 1,Department of Maruthuvam,
National Institute of Siddha, Tambaram Sanatorium, Chennai-47.
Kancheepuram
TAMIL NADU |
09659327457
044-22381314
drmksathesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of confirmed diagnosis by oncologist reports.
2.All cancer patients approaching for Siddha treatment at NIS-OPD |
|
| ExclusionCriteria |
| Details |
1.Patients of not confirmed diagnosis by oncologist reports.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be assessed by no of cases treated in siddha medication,Patients with any type of cancer are most frequently turning to siddha medicine. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome will be assessed by incidence/prevalence of cancer,types of cancer,the reason of patients preference to siddha treatment,type of treatment and mortality. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
24/07/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A hospital based Observational Retrospective study conducted on 2000 cancer patients data will be collected based on inclusion and exclusion criteria. This study was approval Institutional Ethical Committee and number is NIS/IEC/2019/2, dated on 13/09/2019. Data collection based on Tamilnadu cancer Registration form such as Demographic details,Grade of cancer,Types of cancer,Treatment mortalites. To observe incidence/prevalence of cancer and types of cancer. To study the reason of patient’s preference to Siddha treatment. Finally collect the data and analysis will be carried through statistical analytical method.The result of all statistical data findings will be published in the paper UGC approved and indexed peer reviewed journal. |