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

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 worldwide. The 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 DESIG****N: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.

f