| CTRI Number |
CTRI/2020/12/029631 [Registered on: 08/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
A study on siddha diagnostic methodology of ennvagai thervu (eight fold examination)for Vaatha Kirani |
|
Scientific Title of Study
|
A STUDY ON SIDDHA DIAGNOSTIC METHODOLOGY OF ENNVAGAI THERVU FOR VAATHA KIRANI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMGunambikai |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College and Hospital |
| Address |
Department of Noi Naadal,
Govt Siddha Medical College and Hospital, Palayamkottai
Op No.2 Department of Noi Naadal,
Govt Siddha Medical College and Hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9385338023 |
| Fax |
|
| Email |
ambikaamathi03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSVictoria |
| Designation |
Head of the department |
| Affiliation |
Govt Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal,
Govt Siddha Medical College and Hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9444109971 |
| Fax |
|
| Email |
drvictoriathangaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSVictoria |
| Designation |
Head of the department |
| Affiliation |
Govt Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal,
Govt Siddha Medical College and Hospital, Palayamkottai
Viluppuram
TAMIL NADU
627002
India |
| Phone |
9444109971 |
| Fax |
|
| Email |
drvictoriathangaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Siddha Medical College and Hospital, Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Op No.2, Department of Noi Naadal, Govt Siddha Medical College and Hospital,Palayamkottai |
| Type of Sponsor |
Government medical college |
|
|
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 Gunambikai |
Govt Siddha Medical College and Hospital, Palayamkottai |
Op No.2, Department of Noi Naadal,Govt Siddha Medical College and Hospital, Palayamkottai
Tirunelveli
TAMIL NADU |
9385338023
ambikaamathi03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K582||Mixed irritable bowel syndrome, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Above 18 years and below 60 years
2.Abdominal pain
3.Diarrhoea
4.Constipation
5.Bloating
6.Loss of appetite
7. Fatigue |
|
| ExclusionCriteria |
| Details |
1.below 18 years and above 60 years
2.Vulnerable group
3.Any malignancies
4.Piththa Kirani
5.Maha vaatham
6.Moola piththam |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimate the relevance of sage Yugi symptamatology of the disease Vaatha Kirani in patient and relevance in diagnosing the same by siddha diagnostic methodology of Ennvagai thervu |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Interpretation of Vaatha Kirani with the findings of Ennvagai thervu,Manikadai nool, Panjapatchi |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
According to Siddha medicine, there are three humors Vaatham, Piththam, Kabam maintained in our body. This humors are affected by environment, climatic conditions, diet, physical activities and stress. The disease Vaatha Kirani comes under the types of kirani explained by the sage Yugi. This disease is characterized by the symptoms of pain in the abdomen, bloating, loss of appetite , diarrhoea, constipation and fatigue. |