| CTRI Number |
CTRI/2024/06/069420 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
A study on siddha diagnostic methodology for obesity in women |
|
Scientific Title of Study
|
An observational study on siddha diagnostic methodology in women with Athithoolarogam from menarche to menopause |
| 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 M Rajagopal |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Department of Noi Naadal, Government Siddha Medical college and Hospital, Palayamkottai. Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9629339935 |
| Fax |
|
| Email |
dr.raja.rg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Room no 11
Department of noi naadal
Government Siddha Medical College and Hospital palayamkottai 627002
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sundararajan MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Room no 11
Department of noi naadal
Government Siddha Medical College and Hospital palayamkottai 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli 627002,Tamilnadu,India palayamkottai
tirunelveli |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital Palayamkottaii |
| Address |
Government Siddha Medical College and Hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
|
| 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 M Rajagopal |
Government siddha medical college and hospital,Palayamkottai |
Room No.11
Department of Noi
Naadal,
Government
Siddha Medical
College and
Hospital,
Palayamkottai 627002
Tirunelveli
Tirunelveli
TAMIL NADU |
9629339935
dr.raja.rg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government siddha medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Presence of obesity BMI greater than or equal to twenty five
Waist hip circumference ratio reater than point eight
|
|
| ExclusionCriteria |
| Details |
Age below 15 and above 60
Pregnancy and lactation
Atheletes or body builders havin muscular hypertrophy
cardiac illness
Person undergoing treatment for any serious illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document the various neikuri patterns for obesity and also other siddha diagnostic methodology fo athithoolarogam (obesity) |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study nadi nadai & other siddha diagnostic methodology for athithoolarogam(obesity) |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this Study is to document the the siddha diagnostic procedures especially Neerkuri and Neikuri patterns for patients of Athithoolarogam(Obesity)" and also Assessment of other diagnostic methods such as Naadi Nadai and Manikkadai Nool for Athithoolarogam (Obesity) |