| CTRI Number |
CTRI/2020/02/023477 [Registered on: 20/02/2020] Trial Registered Prospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Determination of Possible association between Udal Iyal(Body Constitutions) with Moolam(Hemorrhoids)and Peenisam(Sinusitis) conditions - An Observational Clinical Study |
|
Scientific Title of Study
|
Determination of Possible association between Udal Iyal(Body Constitutions) with Moolam(Hemorrhoids)and Peenisam(Sinusitis) conditions - An Observational Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Sindhu |
| Designation |
PG scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Dept.of Noi Naadal.
National Institute of
Siddha,
Tambaram sanatorium
Chennai 47.
Dept.of Noi Naadal.
National Institute of Siddha, Tambaram sanatorium
Chennai 47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9486139030 |
| Fax |
|
| Email |
dr.sindhu1693@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Elansekaran |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Dept.of Noi Naadal.
National Institute of Siddha, Tambaram sanatorium
Chennai 47.
Dept.of Noi Naadal.
National Institute of Siddha, Tambaram sanatorium
Chennai 47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962536907 |
| Fax |
|
| Email |
sekarnis78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Elansekaran |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Dept.of Noi Naadal.
National Institute of Siddha, Tambaram sanatorium
Chennai 47.
Dept.of Noi Naadal.
National Institute of Siddha, Tambaram sanatorium
Chennai 47.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962536907 |
| Fax |
|
| Email |
sekarnis78@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha Tambaram sanatorium , chennai |
|
|
Primary Sponsor
|
| Name |
Ayothidoss Pandithar Hospital |
| Address |
National Institute of Siddha, Tambaram sanatorium,
Chennai-47. |
| 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 R Sindhu |
Ayothidoss Pandithar Hospital |
National Institute Of Siddha Tambaram Sanatorium
Chennai-47
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9486139030
dr.sindhu1693@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: J019||Acute sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age 16 -70
Patients with Moolam (Hemorrhoids with any degree)
Patients with Peenisam (Sinusitis)
|
|
| ExclusionCriteria |
| Details |
Patients not willing to sign in consent form |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To Analyse the diseases (Moolam, Peenisam) by the Dhegi characterisation in each individual.
|
To analyse the diseases (Moolam, Peenisam) by the Dhegi characterisation in each individual
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study relationship of Medical Astrology among the subjects in the research |
1 1/2 years |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2020 |
| Date of Study Completion (India) |
27/04/2021 |
| 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)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The patients details are selected based on inclusion and exclusion criteria. Then the data will be collected through questionnarie. The relationship of medical astrology related to the diseases are verified. Finally report are prepared and submitted and conclude the possible association of Udal Iyal with Moolam and Peenisam conditions. |