| CTRI Number |
CTRI/2023/06/053666 [Registered on: 08/06/2023] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A prospective comperative study of siddha diagnostic methodologies including medical astrology & thyroid
profile for HYPOTHYROIDISM |
|
Scientific Title of Study
|
A prospective comperative study on siddha diagnostic methodologies including maruthuva jothidaviyal & thyroid profile for KANDA KARAPPAN (Hypothyroidism) |
| 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 SARANYA |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical college and hospital |
| Address |
II year PG scholar Department of Noi naadal Government Siddha Medical College and Hospital Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8883080835 |
| Fax |
|
| Email |
svsaranya5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S SUNDARARAJAN MDS |
| Designation |
Asst professor and HOD |
| Affiliation |
Government Siddha medical college and hospital |
| Address |
Department of Noi naadal Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S SUNDARARAJAN MDS |
| Designation |
Asst professor and HOD |
| Affiliation |
Government Siddha medical college and hospital |
| Address |
Department of Noi naadal Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govenment Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr S SARANYA |
| Address |
II year Department of Noi naadal Government Siddha Medical College and Hospital Palayamkottai Tirunelveli |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Saranya |
Government Siddha Medical college and Hospital |
Department of Noi Naadal
Government Siddha medical college and Hospital
Tirunelveli
TAMIL NADU |
8883080835
svsaranya5@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: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting symptoms of
Dry itchy skin
Facial puffiness
Cold intolerance
Depression
Hoarseness of voice
Weight gain and poor appetite
Paraesthesias
Peripheral oedema
Weakness
|
|
| ExclusionCriteria |
| Details |
Vulnerable group
Cushing syndrome
Myxedema coma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To diagnose Kanda karapan |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Siddha diagnosis specially ENVAGAI THERVU may be used to diagnose KANDA KARAPPAN |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2023 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to access the siddha diagnostic procedures especially neerkuri and neikuri in patients of Kanda karappan which is one of the disease mentioned in Yugi vaithiya chinthamani Assessment of other diagnostic methods such as Naad Nadai Manikadai nool and Maruthuva jothidaviyal are also done. |