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CTRI Number  CTRI/2024/08/071907 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study to know the effect of siddha medicine Irumal chooranam in the treatment of swasakaasam(Bronchial Asthma) 
Scientific Title of Study   An open clinical trial to evaluate the effectiveness of siddha formulation Irumal chooranam in the management of swasakaasam (Bronchial Asthma) among patients reporting at ayothidoss pandithar hospital,National institute of siddha  
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 K MADHESHWARAN 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam National institute of siddha Tambaram Sanatorium kancheepuram Tamilnadu India

Kancheepuram
TAMIL NADU
600047
India 
Phone  9566713066  
Fax    
Email  madheshwaran100@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H NALINI SOFIA 
Designation  Associate Professor 
Affiliation  National Institute of siddha 
Address  Room no 7/8, Department of Maruthuvam National institute of siddha Tambaram Sanatorium kancheepuram Tamilnadu India

Kancheepuram
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  dr.h.nalinisofia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr H NALINI SOFIA 
Designation  Associate Professor 
Affiliation  National Institute of siddha 
Address  Room no 7/8, Department of Maruthuvam National institute of siddha Tambaram Sanatorium kancheepuram Tamilnadu India

Kancheepuram
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  dr.h.nalinisofia@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha Tambaram Sanatorium Kancheepuram 600047 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheeepuram 600047 
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 K Madheshwaran  Ayothidoss pandithar hospital  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheeepuram 600047
Kancheepuram
TAMIL NADU 
9566713066

madheshwaran100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Irumal Chooranam  A Compound herbal drug powder indicated to treat bronchial asthma advised to intake 1.5 grams twice a day for 48 days  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient who are willing to undergo Pulmonary function test FEV1 between 50%- 80% will be taken.
2.Patients with clinical symptoms of Wheezing, Cough with or without expectoration,Dyspnea, Tightness of chest ,H/O Wheezing minimum 2 episodes per week.Any 2 or more symptoms will be included 
 
ExclusionCriteria 
Details  1.Having covid 19 or recent period of covid 19 infection
2.Restrictive Lung disease
3.Tuberculosis
4.Emphysema
5.Pleural effusion
6.Pneumothorax
7.Cardiac diseases
8.Renal diseases
9.Pregnancy and Lactation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome is assessed mainly by the values of pulmonary function
test and improvement in the clinical signs and symptoms by asthma control
questionnaire (ACQ) pre and post treatment. 
48 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in laboratory parameters of IgE, Absolute Eosinophil Count(AEC), ESR pre and post treatment  48 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2 
Date of First Enrollment (India)   15/08/2024 
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="0"
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  

BACKGROUND


            According to Siddha system of medicine, disease are classified into 4448 types. One among them is Swasakaasam also known as Eraippu noi. Swasakaasam is attributed to the

 derangement of KaphamThe amplified kapham humour alone or otherwise associated with other deranged humours, either vatham or pitham affect the throat, nose, respiratory air ways and lungs. Due to the increase in kapham humour, mucus secretion is increased causing fever and other symptomps.

 

According to the text Yugi Vaithiya Chinthamani,  Kaasam classified into 12 types. “Swasakaasam” is one among them. This can be correlated to “Bronchial asthma” in modern terms. As per the above text, etiology of this disease includes intake of foods which causes rise in kapham  humor, allergic foods like ragi, cereals etc, exposure to cold weather and rain, inhalation of smoke, mental stress, anger and unpleasant  odour.

Asthmatic patients are having a hyper reacting bronchial tree. Bronchoconstriction  may be due to various factors, known and unknown. Known substances are Histamine, SRS-A (Slow reacting substance of anaphylaxis), Platelet activating factor(PAF), Eosinophil Chemo tactic factor of Anaphylaxis (ECF-A) and other unidentified substance liberated from the mast cells. The factors responsible for releasing these mediators are allergy, infection, exercise, psychological factors, change of temperature and humidity, smoking  etc .

In Asthma, Chronic inflammation is associated with airway hyper-responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing particularly at night and in the early morning. These episodes are usually associated with widespread but variable airflow obstruction within the lung that is often reversible, either spontaneously or with treatment. Symptoms may be precipitate by exercise, cold weather, allergens exposure (eg: Pets, Pollen, Dust mites, Occupational, Viral tract Infection), Drugs   (B Blockers, Aspirin, NSAIDS), Tobacco smoke, over weight and Emotional Stress .

Approximately 300 million people worldwide currently have asthma and its prevalence increases by 50% every decade . It is estimated that there may be an additional 100 million persons with asthma by 2025. Asthma is more common in female adults than male adults. Among them Female adults are 9.8% compared to male adults 6.1%.

 Annually, the World Health Organization (WHO) has estimated that 15 million disability- adjusted life-years are lost and 250,000 asthma deaths are reported worldwideThe total burden of asthma in India an overall prevalence of 3% is estimated at over 30million patients. In India, there is a prevalence of about 2.4% in adults over 15 years of age.


 OBJECTIVE

     PRIMARY OBJECTIVE      

● To evaluate the clinical effectiveness of  siddha formulation  IRUMAL CHOORANAM  in  the Management of SWASAKASAM  (BRONCHIAL ASTHMA) by using  Pulmonary  function  test.


          ● To observe the changes in clinical symptoms by asthma control Questionnaire. 

       SECONDARY OBJECTIVE

          ● To observe the changes in clinical  laboratory  parameters  such  as  IGE ,AEC, before and after Treatment. 


         STUDY DESIGN  :An open clinical trial

STUDY PLACE    :OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium, Chennai-47.

 STUDY PERIOD  :12 months

SAMPLE SIZE    :30 patients


          TREATMENT:

    Internal medicine:  IRUMAL CHOORANAM      

Dosage : verugadialavu  (1.5gm ) twice a day

Adjuvant : Honey

Duration of treatment  : 48 days

Reference : Brahmamuni  karukkadai  suthiram 380

Page No  : 77

Edition  : first edition, February 1998

Author : S.B.Ramachandran

Published by : Thamarai  noolagam, 7,NGO Colony, 3rd street,vadapalani, Chennai.


           INCLUSION  CRITERIA;

Age between 18-60 years.

Sex: Male Female & Transgender.

Patient who are willing to undergo Pulmonary function test (FEV1 between  50% - 80% ) will be  taken.

Patients with clinical symptoms of

· Wheezing

· Cough with or without expectoration

· Dyspnea

· Tightness of chest

· H/O Wheezing minimum 2 episodes per week (Any 2 or more symptoms will be included)

Patients who are willing to undergo radiological investigations and provide blood sample for  lab investigations.

 

          EXCLUSION  CRITERIA;

                Having covid 19 (or) recent period of covid 19 infection

                Restrictive Lung disease

Tuberculosis

Emphysema

Pleural effusion

Pneumothorax

Cardiac diseases

Renal diseases

Pregnancy  and  Lactation

             WITHDRAWAL  CRITERIA:

             Intolerance  to the drug  and  development  of  any  serious  adverse effect during drug  trial.

             Poor patient  compliance & defaulters.

             Patient  unwilling to continue the course of clinical Study.

             Occurrence  of  any other systemic illness.

            PRIMARY OUTCOME

           Primary Outcome is assessed  mainly by  the  values of  pulmonary function test and improvement in the clinical signs and symptoms by asthma control questionnaire(ACQ) pre and post treatment.

SECONDARY OUTCOME

          Changes in laboratory parameters of IgE, Absolute Eosinophil Count(AEC), ESR pre and post treatment.

RESULTS AND DISCUSSION

          The Results will be Statistically analysed and reported.

KEYWORDS: Swasakaasam, Irumal chooranam, Respiratory diseases, ACQ.


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