| CTRI Number |
CTRI/2023/02/049508 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
24/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
finding siddha based body constitutions for anaemic patients |
|
Scientific Title of Study
|
Determination of the possible association between specific udal iyal (body constituents) with PAANDU (anaemia) - an observational clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Tharanghiney |
| Designation |
PG Scholar |
| Affiliation |
Ayothidoss Pandithar Hospital |
| Address |
Room no 5
Department of Noi Naadal
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9629629043 |
| Fax |
|
| Email |
dr.tharanghiney@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Elansekaran |
| Designation |
Associate Professor |
| Affiliation |
Ayothidoss Pandithar Hospital |
| Address |
Room no 5
Department of Noi Naadal
National Institute of Siddha
Chennai-47
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962536907 |
| Fax |
|
| Email |
sekarnis78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Tharanghiney |
| Designation |
PG Scholar |
| Affiliation |
Ayothidoss Pandithar Hospital |
| Address |
Room no 5
Department of Noi Naadal
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9629629043 |
| Fax |
|
| Email |
dr.tharanghiney@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 5
Department of Noi Naadal
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 |
| Dr S Tharanghiney |
National Institute of Siddha |
Room no 5
Department of Noi Naadal
National Institute of Siddha
Tambaram Sanatorium
Chennai-47
Kancheepuram
TAMIL NADU |
9629629043
dr.tharanghiney@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: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Paandu(anaemia) with Hb moderate(8.0-10.9)gm/dl to severe(lower than 8.0gm/dl) |
|
| ExclusionCriteria |
| Details |
Patients not willing tosign in consent form.
Patients with chronic systemic illness.
Vulnerable groups (children, pregnanat women, cognitively impaired). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The possible association of Dhegi characterization in Paandu patients will be obtained based on odds ratio. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Analyse the correlation of Naadi and Neikuri. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2023 |
| Date of Study Completion (India) |
20/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/07/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This Case control study will be conducted in National Institute of Siddha with Anemia patients. The Patients will be Selected based on Inclusion and exclusion criteria, 48 cases and 48 controls will be enrolled on this study. Dhegies questionarie will be asked to both cases and control. From that we will arrive which particular Dhegies are prone to Anemia. |