| CTRI Number |
CTRI/2023/06/054311 [Registered on: 22/06/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| 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 among “Eri Kunmam†(Peptic Ulcer) patients |
|
Scientific Title of Study
|
An Observational Study on Siddha Diagnostic Methodology and exploration of disease management among Eri Kunmam patients attending OPD in GSMC & H Palayamkottai |
| 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 K P S Rafic Raja |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Department of Noi Naadal, Government Siddha Medical college and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9789566471 |
| Fax |
|
| Email |
raficdr94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A BALAMURUGAN |
| Designation |
Lecturer, Grade-II |
| 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
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A BALAMURUGAN |
| Designation |
Lecturer, Grade-II |
| 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
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443403094 |
| Fax |
|
| Email |
balamurugan.aditya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital, Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital, Palayamkottai |
| Address |
Government siddha medical college and hospital, Palayamkottai, Tirunelveli, Tamil Nadu. |
| 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 K P S RAFIC RAJA |
Government siddha medical college and hospital, palayamkottai |
Room no 2,
Department of NoiNaadal,
Government siddha medical college and hospital,
Palayamkottai,
Tirunelveli,
TAMIL NADU
Tirunelveli
TAMIL NADU |
9789566471
raficdr94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College, Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Burning sensation in the upper abdomen
Borborygmus
Ptyalism associated with nausea
Headache
Abdominal distension
Giddiness
Excessive sweating in hair follicles
Diarrhoea
Loss of body weight
Loss of appetite
Burning sensation all over the body
Cough
|
|
| ExclusionCriteria |
| Details |
Achalasia
Cholelithiasis
Hiatus hernia
Biliary colic
Carcinoma of stomach
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Neerkuri(Siddha Urine analysis methodology) & Neikuri patterns (Siddha Urine analysis pattern) in ERI KUNMAM patients at a single visit. |
8 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the Manikkadai nool(Siddha thread diagnostic tool) along with Neerkuri(Siddha Urine analysis methodology) & Neikuri patterns (Siddha Urine analysis pattern) in ERI KUNMAM patients at a single visit.
|
8 minutes |
|
|
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)
|
03/07/2023 |
| 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
|
This study is designed to assess the siddha diagnostic procedures especially Neerkuri and Neikuri (Urine analysis in Siddha system of medicine) in patients of "Eri Kunmam" (peptic ulcer). Assessment of other diagnostic methods such as Naadi Nadai (Siddha Pulse diagnostic method) and Manikkadai Nool is also done. |