Effectiveness of Thoothuvalai nei in the management of Swasakaasam ( Bronchial asthma)

Phase 3

Not yet recruiting

• Conditions: Mild intermittent asthma,

• Registration Number: CTRI/2023/09/057541
• Lead Sponsor: National Institute Of Siddha

Brief Summary

**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. “***Swasakaasamâ€*** 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-23
• Last Update Posted: 2023-12-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Age between 18to60 years Sex Male Female and Transgender Patients with clinical symptoms of Wheezing Cough with or without expectoration Dyspnea Tightness of chest Wheezing minimum 2 episodes per week Any 2 or more symptoms will be included Patient who are willing to undergo Pulmonary function test FEV1 50to80 will be taken Patients who are willing to undergo radiological investigations and provide blood sample for lab investigation.

Exclusion Criteria

Restrictive Lung disease Tuberculosis Emphysema Pleural effusion Pneumothorax Cardiac diseases Renal diseases Pregnancy and Lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome is assessed by comparing the lung volumes & capacities in pre & post	2 MONTHS - SCREENING | 2 MONTHS - PATIENT ENROLLMENT | 2 MONTHS - OUTCOME ASSESSMENT
treatment using pulmonary function test reports	2 MONTHS - SCREENING | 2 MONTHS - PATIENT ENROLLMENT | 2 MONTHS - OUTCOME ASSESSMENT

Secondary Outcome Measures

Name	Time	Method
Changes in the clinical symptoms by Asthma control Questionaire	Changes in laboratory parameters of IgE, AEC, ESR before & after treatment.

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Ayothidoss Pandithar Hospital

🇮🇳Chennai, TAMIL NADU, India

V S Deepthy

Principal investigator

9080311310

deepthyrathan665@gmail.com