| CTRI Number |
CTRI/2025/06/089603 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association Between Body constitution (Yakkai Ilakkanam) and Serum IgE in Bronchial Asthma Patients: A Cross-Sectional Study at NIS |
|
Scientific Title of Study
|
A Cross- Sectional study to evaluate the association of Yakkai Ilakkanam (Siddha Somatotype) among Bronchial Asthma patients (Swasakaasam) with Serum IgE reporting at NIS |
| 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 Vasuki R |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching Block 2
Department of Noi Naadal
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai TAMIL NADU 600047 India |
| Phone |
9597161475 |
| Fax |
|
| Email |
vasukisiddha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Elansekaran S |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching Block 2
Department of Noi Naadal
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai TAMIL NADU 600047 India |
| Phone |
9962536907 |
| Fax |
|
| Email |
sekarnis78@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Elansekaran S |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Teaching Block 2
Department of Noi Naadal
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai TAMIL NADU 600047 India |
| Phone |
9962536907 |
| Fax |
|
| Email |
sekarnis78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Chennai- 47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| 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 Vasuki R |
National Institute of Siddha |
OPD and IPD of Ayothidoss Pandithar Hospital
Room No, 20/21 Department of Noi Naadal
Tambaram Sanatorium
Chennai-47 Chennai TAMIL NADU |
9597161475
vasukisiddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Siddha, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Known cases of Bronchial asthma with elevated serum IgE greater than 100 IU/mL |
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating women
Participants with chronic systemic illness and vulnerable group
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of Yakkai Ilakkanam among Bronchial asthma patients with elevated serum IgE attending NIS OPD and IPD will be described |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The relationship between the Siddha diagnostic tools panchapatchi & Manikadai Nool with serum IgE among Bronchial asthma patients will be evaluated
The Naadi observed in the subjects will be documented
|
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="143" Sample Size from India="143"
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)
|
21/07/2025 |
| 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="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
|
The
Siddha system of medicine is an ancient system of medicine developed by saints
called Siddhars. The Siddha system of
medicine has been in practice in the southern part of India for several
centuries. It takes into account various physiological and scientific data that
include age, sex, race, eightfold examination (Envagaithervu), geographical habitat (Ainthinai), weather and climatic variations (Pozhuthugal), body constitutions (Thega ilakkanam), etc., for the effective diagnosis and treatment
of patients to eradicate their disease. Of these, Yakkai ilakkanam has a detailed description of the physique,
physiological, and psychological characters of three dominant somatotypes (vatha thegi, pitha thegi, kabha thegi). Dhegi
stands for nature of the body in terms of three humours and is determined at
the time of embryo formation. On behalf of this, Siddha classical literature Vaithiya Chindhamani (Sigitcha Rathna Deepam
Part 2), emphasizes that a person of particular
Yakkai ilakkanam is prone to a
particular pattern of diseases. In that literature, Bronchial asthma comes
under kabha thegi among the three humours. According to the text Yugi
Vaithiya Chinthamani - 800, kasam classified into 12 types. “Swasa
kaasam” is one among them which is correlated
with Bronchial asthma in modern science. In
2019, Global Burden of Disease (GBD) collaborators estimated that over 260
million people globally had poorly controlled asthma (diagnosed asthma with
wheezing within past 12 months) with a high count of disabilities and premature
deaths across many low- and middle- income countries. The most substantial known risk factor is atopy, which is
characterized by the genetic tendency to produce specific immunoglobulin E
(IgE) antibodies in response to common environmental allergens. Nearly
one-third of children with atopy will develop asthma later in life. So,
this study aims to analyze the possible association between yakkai ilakkanam
and serum IgE among Bronchial asthma patients. This will be more helpful to
provide specific diet regimen after assessed the inherent body features in an
easier way.
Trail design: A Cross – Sectional Observational
Study. Study Place is OPD & IPD National Institute of Siddha, Tambaram
Sanatorium. Study Period: 18 Months. The sample size is 143 patients. Patients
will be screened between the time period of 8.00 a.m. to 12.00 p.m. Patients satisfying the inclusion
and exclusion criteria will be admitted to the trial. Informed consent will be
obtained from the patients. The laboratory investigation especially Serum IgE
level will be detected from all participants. The participants will be
subjected to clinical assessment and diagnosis by thegi characterisation
Questionnaire and the proportion of Yakkai
Ilakkanam among Bronchial asthma patients
with elevated serum IgE attending NIS OPD and IPD will be described. The relationship between the Siddha
diagnostic tools panchapatchi and Manikadai Nool with serum IgE
among Bronchial asthma patients will be evaluated. The Naadi observed in
the subjects will also be documented. |