| CTRI Number |
CTRI/2022/02/040141 [Registered on: 09/02/2022] Trial Registered Prospectively |
| Last Modified On: |
04/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To determine the effectiveness of Siddha management in Type 2 Diabetic patients |
|
Scientific Title of Study
|
Effectiveness of Siddha management in Type 2 Diabetic patients (Madhumegam) at NIS OPD - A Retrospective Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR G Archana |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 6,Department of Nanju Maruthuvam,Ayothidass Pandithar Hospital,
National Institute of Siddha,
Tambararam sanatorium
chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
9790075305 |
| Fax |
|
| Email |
archuarchana6024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR G Archana |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 6,Department of Nanju Maruthuvam,Ayothidass Pandithar Hospital,
National Institute of Siddha,
Tambararam sanatorium
chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
9790075305 |
| Fax |
|
| Email |
archuarchana6024@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Shanmugapriya |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 6,Department of Nanju Maruthuvam,Ayothidass Pandithar Hospital,
National Institute of Siddha,
Tambararam sanatorium
chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
9962513101 |
| Fax |
|
| Email |
sppriyaathamu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
Ayothidass Pandithar Hospital |
| Address |
National Institute of Siddha
Tambaram Sanatorium
Chennai - 600047 |
| 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 G Archana |
Ayothidass Pandithar Hospital |
Room 6
Department of Nanju maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai-47
Kancheepuram
TAMIL NADU |
9790075305
archuarchana6024@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: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Type 2 Diabetes mellitus
2.Patient taking Siddha medicines for DM for minimum period of 1 year. |
|
| ExclusionCriteria |
| Details |
1.Patient with Irregular medication
2.Patient not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effectiveness of Siddha medicines taken by type 2 Diabetes patients.Risk of other systemic diseases will be assessed by monitoring the Lipid profile. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
6 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
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes is a chronic metabolic disease characterized by elevated levels of blood glucose (or blood sugar) which leads overtime to serious damage to heart, blood vessels, eyes ,kidneys and nerves. As per WHO, both the number of cases and prevalence of Diabetes mellitus is steadily increasing for the past few decades. Many of the patients with Diabetes mellitus are being treated only with the siddha medicines alone.There is a need to study the impact of siddha medicines in diabetes.Since there is no study has been conducted on the particular area,this study involves collecting data from the diabetic patients who are taking only Siddha medicines for Diabetes mellitus from Out-Patient Department, Ayothidass Pandidhar hospital,NIS, about their glycemic control. |