A Study on Kadukkai Vadagam in the management of Swasakasam ( Bronchial Asthma)

Phase 2

Not yet recruiting

• Conditions: Moderate persistent asthma,

• Registration Number: CTRI/2023/08/056871
• Lead Sponsor: National Institute of Siddha

Brief Summary

**BACKGROUND:** *SWASAKASAM* is due to the derangement of kapham humor.The increased kapham either with vatham or pitham affects nostrils, throat ,respiratory pathways and lungs. This causes more inflammation leading to disturbances in inspiration and expiration. According to *YUGI VAITHIYA CHINTHAMANI* 800,Kasam can be classified as 12 types and *swasakasam* is one among them. The important causes of the diseases are exposure to cold foods, water and climate, inhalation of smoke, allergic items, intake of non vegetarian, starving on hunger ,stealing foods, uttering false talks etc,.This is an open clinical trial that evaluates the effectiveness of *KADUKAI VADAGAM* in the management of *SWASAKASAM*(Bronchial Asthma)

**OBJECTIVE** :

PRIMARY OBJECTIVE : 1.To evaluate the clinical effectiveness of *KADUKKAI VADAGAM* in the Management of *SWASAKASAM* (BRONCHIAL ASTHMA) by using pulmonary function test.

2.To observe the changes in clinical symptoms by asthma control questionnaire

3.The Standardization of the trail drug will be done as per PLIM guidelines.

SECONDARY OBJECTIVE : To observe the changes in clinical laboratory parameters such as IGE,AEC, before and after treatment

**METHODOLOGY:** A total of 30 diagnosed patients of *Swasakasam*( Bronchial Asthma) within the age limit of 18 to 60 years willing to participate in the study by signing the consent form will be enrolled in the study based on inclusion criteria. Known case of Diabetes mellitus (Uncontrollable), Cardiac disease, Renal disease, and Other lung diseases will be excluded.

OUTCOME:

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 pre and post treatment.

SECONDARY OUTCOME: Laboratory parameters such as IgE, Absolute Eosinophil Count (AEC) ,pre and post treatment.

RESULTS AND DISCUSSION : The result will be statistically analysed

KEYWORDS: *Swasakasam*, Bronchial Asthma, *kadukai vadagam*

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-09
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Adults who are diagnosed with bronchial asthma are included in the study 2.Patients with a clinical symptoms of Swasakasam -Cough with or without expectoration,Recurrent episodes of Wheezes, Tightness of chest,Dyspnea.,Breathing difficulty.
• (Any of 2 or more symptoms will be included) 3.Patient who are willing to take radiological investigation and provide blood sample for lab investigation.
• 4.Patient who are willing to undergo Pulmonary function test 5.FEV1 is 50% to 80%.

Exclusion Criteria

1.Diabetes mellitus (Uncontrollable) 2.K/C/O Cardiac disease 3.K/C/O Renal disease 4.K/C/O Other lung diseases 5.Pregnancy 6.Lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is assessed by the values of pulmonary function	8 WEEKS
test	8 WEEKS

Secondary Outcome Measures

Name	Time	Method
1.Improvement in the clinical signs & symptoms by Asthma control	questionnaire pre & post treatment

Trial Locations

Locations (1)

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

Ayothidoss Pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr P Dhanakumari

Principal investigator

9524825994

dhanakumari1996@gmail.com