| CTRI Number |
CTRI/2018/06/014422 [Registered on: 05/06/2018] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the characteristics of anaemic patients reporting at out patient department of national institute of siddha. |
|
Scientific Title of Study
|
"Prevalence of Paandu (Anaemia) amongst patients reporting at out patient department of National Institute of Siddha" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siva Lakshmi S |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of maruthuvam National institute of siddha
Tambaram sanatorium
Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9445245372 |
| Fax |
|
| Email |
sslaxmimbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Vetha merlin kumari |
| Designation |
Lectuer |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha
Tambaram sanatorium
Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siva Lakshmi S |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Department of maruthuvam National institute of siddha
Tambaram sanatorium
Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9445245372 |
| Fax |
|
| Email |
sslaxmimbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of siddha
Tambaram sanatorium
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
Ayothidoss pandithar hospital |
| Address |
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 Siva Lakshmi S |
Ayothidoss pandithar hospital |
Department of siddha
National institute of siddha
Tambaram sanatorium
chennai 47
Kancheepuram
TAMIL NADU |
9445245372
sslaxmimbbs@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
anaemia, (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients among the age group of 13 years to 75 years |
|
| ExclusionCriteria |
| Details |
Anaemia due to acute blood loss |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyse the predisposing factors of Anaemia amongst the subject
|
one day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the distribution of anaemia among various age group (13-75 years) ,sex,socioeconomic status and its association with various systemic illness. |
one day |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "500"
Final Enrollment numbers achieved (India)="500" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2018 |
| Date of Study Completion (India) |
25/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published on International Journal of ayurvedha and pharma research. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It is a observational type of cross sectional study which is conducted to evaluate the prevalence of anemia amongst the patient reporting at the national institute of siddha. And to evaluate the distribution of anemia among various age group (13-75) ,sex, socioeconomic status and its association with various systemic illness. This cross sectional study revealed that the over all prevalence of anaemia is 45.6%. In that female are more affected when compared to male. The female aged between 15-49 years are more prone to the anaemia (45.2%) and most of the female (29.7%) belongs to mild anaemia. The prevalence of anaemia was high among the people belongs to upper lower status (12.2%)
|