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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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