| CTRI Number |
CTRI/2020/12/029621 [Registered on: 07/12/2020] Trial Registered Prospectively |
| Last Modified On: |
05/12/2020 |
| 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 of neerkuri(characteristics of urine) and neikuri(oil spreading pattern in urine) for nazhuvai vatham |
|
Scientific Title of Study
|
A Study on Siddha Diagnostic Methodology Of Neerkuri and Neikuri for Nazhuvai Vatham |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Banupriya |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Noi Naadal,
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8778691605 |
| Fax |
|
| Email |
drbanu333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan MDS |
| Designation |
Reader |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Noi Naadal
Government siddha medical college and hospital
Palayamkottai
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 |
Reader |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Noi Naadal
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
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.
Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
Government siddha medical college and hospital
Palayamkottai
Tirunelveli |
| 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 |
| DrMBanupriya |
Government siddha medical college and hospital, Palayamkottai |
Department of Noi Naadl, Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
8778691605
drbanu333@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: K210||Gastro-esophageal reflux disease with esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Group 1
1 Age between 20-70 years
2 Regurgitation
3 Pain in upper abdomen
Group 2
1 Feeling of fullness in upper abdomen after eating
2 Nausea
Patients presenting with all symptoms of group 1 and 1-2 symptoms of group 2 will be included in this study |
|
| ExclusionCriteria |
| Details |
1 Eri gunmam
2 Azhal gunmam
3 Any malignancies
4 Vulnerable group
5 physical injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Siddha diagnosis specially Neerkuri and Neikuri may be used to confirm Nazhuvai vatham |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Manikadai Nool Envagai Thervu and Panchapatchi are used for the diagnosis of Nazhuvai vatham
Making treatment easy by framing prompt diagnosis
To prevent complications related to the disease |
1 Year |
|
|
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)
|
11/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According to siddha concept, the term disease is defined as alteration in uyir thathukkal and udal thathukkal. The disease Nazhuvai vatham comes under the class of vatha noigal classified by Sage YUGI MUNI. It is characterized by the symptoms of regurgitation, pain in upper abdomen, feeling of fullness in upper abdomen after eating, nausea. |