| CTRI Number |
CTRI/2025/10/095997 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to determine the possible association between the participants Yakkai Ilakkanam somatotypes Naadi and Manikkadai Nool examination |
|
Scientific Title of Study
|
Determining the possible association between the selected diseases conditions of patienets visiting NIS OPD with their Yakkai Ilakkanam somatotypes Naadi and Manikkadai Nool examination through a cross sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Harikrishnan |
| Designation |
Postgraduate Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 20/21 Department of Noi Naadal Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram Sanatorium Chennai 47In
Tambaram Sanatorium
chennai 600047
Chennai
TAMIL NADU
600047
India |
| Phone |
8903248838 |
| Fax |
|
| Email |
harikrishnanm070997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr G J Christian |
| Designation |
Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Noi Naadal Department OP room no 20/21 National Institute of Siddha Tambaram Sanatorium chennai 600047
Tambaram Sanatorium
chennai 600047
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr G J Christian |
| Designation |
Head of the Department |
| Affiliation |
National Institute of Siddha |
| Address |
Noi Naadal Department OP room no 20/21 National Institute of Siddha Tambaram Sanatorium chennai 600047
Tambaram Sanatorium
chennai 600047
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha Tambaram Sanatorium chennai 600047 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Harikrishnan |
National Institute of Siddha |
Noi Naadal Department OP room no 20,21 National Institute of Siddha Tambaram Sanatorium Chennai 600047
Chennai
TAMIL NADU |
8903248838
harikrishnanm070997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NationalInstituteofSiddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (2) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (3) ICD-10 Condition: I159||Secondary hypertension, unspecified, (4) ICD-10 Condition: M479||Spondylosis, unspecified, (5) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants reporting at NIS OPD |
|
| ExclusionCriteria |
| Details |
known case of Pshyciatric disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between particular yakkai ilakkanam and siddha diagnostic parameters in terms of correlation and coefficient value |
Baseline 0th day
End point 1 week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
21/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
BACKGROUND Siddha is believed to be one of India oldest systems of medicine which is based on a combination of ancient medicinal practices and spiritual disciplines Siddha literature named Sikicha rathina deepam explains about the risk of occurece of specific diseases in subjects with specific Yakkai through a validated questionnaire this study might be helpful in standardizing the diagnosis of the subjects in an siddha opd using the somatotypes naadi and manikkadai nool which does not require any prior preparation that can be done at any time OBJECTIVES To determine the possible association between their clinical condition of the participants and their yakkai ilakkanam somatotypes naadi and manikadai nool who report at NIS OPD STUDY TYPE an observational study STUDY DESIGN A cross sectional study STUDY PLACE Outpatient department Ayothidoss Pandithar Hospital National Institute of siddha chennai 47 SAMPLE SIZE 15 STUDY PERIOD 18 months OUTCOME OF THE STUDY Association between particular yakkai ilakkanam and siddha diagnostic parameters in terms of correlation and coefficient value
|