| CTRI Number |
CTRI/2024/06/069576 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
DESCRIPTIVE |
| Study Design |
Other |
|
Public Title of Study
|
An observational study on siddha diagnostic methods and line of treatment for Pitha Gunmam(Duodenal ulcer) |
|
Scientific Title of Study
|
An Observational Study On Siddha Diagnostic Methodology Especially Neerkuri, Neikuri And Elaborating Line Of Treatment, Noi Anuga Vidhimuraigal For PITHA GUNMAM |
| 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 D PANDI PRIYA |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Address |
Department Of Noi Naadal, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
6385834672 |
| Fax |
|
| Email |
drpandipriya98@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, 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, 627002
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, 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 D Pandi priya |
Government Siddha Medical College & Hospital |
Department of Noi Naadal
Branch V
Room no 11
Tirunelveli
TAMIL NADU |
6385834672
drpandipriya98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K269||Duodenal ulcer, unspecified as acute or chronic, without hemorrhage or perforation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with presenting symptoms of
Burning pain in stomach
Nausea
Vomiting
Fatigue
Increased thirst
Constipation
Yellowish discolouration of the face
Dizziness while sitting in sunlight |
|
| ExclusionCriteria |
| Details |
Other than gunmam patients
Cholelithiasis
Appendicitis
Colitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the Neerkuri & Neikuri for Pitha Gunmam |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Naadi nadai for Pitha Gunmam patients
To assess Manikadai nool in Pitha Gunmam patients |
1.5 years |
|
|
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)
|
15/07/2026 |
| Date of Study Completion (India) |
11/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Background The study is designed to document the neikuri patterns and other siddha diagnostic methodology for patients with PITHA GUNMAM - Duodenal ulcer Expected outcome Siddha diagnosis especially Neerkuri, Neikuri, Naadi and Manikadai Nool can be use to confirm Pitha Gunam. Proper line of treatment and Noi Anuga Vidhimuraigal could be framed based on dearrangement. |