An open non randomized clinical trial to evaluate the effectiveness of siddha formulation Thoothuvalai nei in the management of swasakaasam (Bronchial asthma)

Background:

Siddha system of medicine is one of the ancient systems contemporaneous with those of the submerged lands, Egyptian, Mesopotamian, Chinese, and Grecian medicines. The ancient siddhars knew the scientific truth by meditation and  worked wonders through their mental force.The siddha system is based on a combination of ancient medicinal practices and spiritual disciplines as well as alchemy and mysticism. As herbs, metals, minerals, animals and its derivatives are the source of siddha medicines. Siddha is the only system comprising 64 varieties of medicines i.e. 32 classifications of internal medicines and 32 classifications of external medicines. According to siddha system of medicine change in diet, life style, environmental and genetic factors are the key factors predisposed for the instigation of each disease via disturbing the vital forces termed Vali, Azhal, Iyyam. Asthma is     attributed to the derangement of Kapha humour. The amplified kapham humour alone or  otherwise associated with other deranged humours, either vatham or pitham affect the throat, nose, respiratory air ways and lungs.

According to the text Yugi Vaithiya Chinthamani, Kaasa**m 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. Bronchial asthma is a heterogeneous pulmonary disorder characterized by recurrent episodes of cough, breathlessness and wheezing, which may resolves spontaneously or after the use of bronchodilator medication. There has been a sharp increase in the global prevalence morbidity, mortality and economic burden         associate with asthma over the last 40 years. 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. According to WHO estimation 262 million people died of asthma in 2019. Worldwide approximately 1,80,000 deaths are attributable to asthma every year. In Asia, increased prevalence is likely to be particularly dramatic in India and china. The total burden of asthma in India an overall prevalence of 3% is estimated at over 30 million patients. In India, there is a prevalence of about 2.4% in adults over 15 years of age. So there is a noticeable increase in health care burden for asthma in several area of the world to change in it epidermiology and symptoms. The ingredient of this drug said to possess expectorant, stimulant, carminative, antispasmodic action***,*** immunomodulatary, bronchodailator, anti-oxidant, anti- inflammatory, anti-histamine actions and cost effective treatment. The Thoothuvalai Nei, has not undergone any clinical trial, so far. So, it is proposed to carry  an open clinical trial to find out its efficacy in SwasaKaasam. In our OPD of Ayothidoss pandithar hospital, National Institute of Siddha we are receiving more number of Swasakaasam cases having daily symptoms of wheezing, sleep disturbance, unable to do their daily activities, which is the driving force                        behind to select this condition for my minor project study.

Primary objectives:§                      To assess the therapeutic effectiveness of Siddha formulation “THOOTHUVALAI NEI†in the management of “SWASAKAASAM†(BRONCHIAL ASTHMA) by using Pulmonary function test (PFT).

Secondary objectives:

§                      To observe the changes in clinical symptoms by Asthma control Questionnaire before and after treatment.

§                      To evaluate clinical lab parameters such as IgE, AEC, ESR before and after treatment.

Study Design: An open non randomised clinical trial with a total of 10 diagnosed patients of swasakaasam (Bronchial Asthma) reporting at Ayothidoss Pandithar Hospital, National Institute of Siddhawill be enrolled in the study.Patients with a known history of restrictive Lung disease , Tuberculosis , Emphysema , Pleural effusion, Pneumothorax, Cardiac diseases Renal diseases , pregnancy and Lactation will be excluded.The trial drug Thoothuvalai Nei as internal medicine will be given for 48 days along with 2 months follow-up.

Primary outcome:

By comparing the lung volumes and capacities in pre and post  treatment by using pulmonary function test reports.

Secondary outcome:

Ø  Changes in the clinical symptoms by Asthma control Questionnaire before and after treatment.

Ø  Changes in laboratory parameters of IgE, AEC, and ESR before and after treatment.