A study on efficacy of Ardraka Arka along with standard care in the management of Bronchial Asthma(Tamaka shwasa)

Phase 2

Not yet recruiting

• Conditions: Mild intermittent asthma. Ayurveda Condition: Tamaka shwasa, (2) ICD-10 Condition: J453||Mild persistent asthma. Ayurveda Condition: TAMAKA SHWASA, (3) ICD-10 Condition: J453||Mild persistent asthma. Ayurveda Condition: PRANAVAHASROTOVIKARAH,

• Registration Number: CTRI/2023/08/056522
• Lead Sponsor: DrPuja MS

Brief Summary

Tamaka Shwasa is an illness of Pranavaha Srotas, originating in the Pittasthana, caused due to the vitiation of Vata and Kapha Doshas andafflicting the Rasa Dhatu. It is characterized by Shwasa Kruchrata, Kasa, Ghurghuraka. Ayurveda describes Tamaka Shwasa as Yapya Vyadhi.1 The clinical symptomatology of Tamaka Shwasa is similar to that of Bronchial asthma in contemporary science, which is one among the commonest chronic illnesses in childhood period.2Bronchial asthma is defined as heterogenous disease characterized by the symptoms of recurrent episodes of wheezing, breathlessness, chest tightness and cough which vary over time intensity. The airways show chronic inflammation, hyperresponsiveness, and airflow limitation which is reversible, recurrent and variable.3Among the 1.3 billion people in India, about 6 % of children and 2% of adults are affected with Bronchial asthma.4 The prevalence of asthma is increasing with time and additional 100 million people are expected to develop asthma by the year 2025.5In a recent study (2021), overall prevalence of Asthma, in the rural areas of North Karnataka was 4% among 5-16 years aged children.6. Study from Mysore has reported a prevalence of 17.14% Asthma in children in the age group of 6–14 years also.7 This alarming raise in the prevalence of Bronchial Asthma can be accounted to factors such as Atmospheric pollution (Rajodhuma), rapid environmental 6changes, an adaptation of newer dietic preparations, excessive exercise(Vyayama Karma), and tremendous psychological stress.8 Childhood Asthma is responsible for school absenteeism, restricted activities, and psychological impact on the family also, there is impact on socio-economic status, since there is increased unscheduled hospital visits.Some of the common complications of bronchial asthma if left unattended, are sinusitis, allergic rhinitis, urinary incontinence and psychological problems like anxiety, depression and panic attacks.9In contemporary science, current challenges in pediatric asthma management include Inhaled corticosteroids which may result in Growth delay, irritable or difficult behavior and oral candidiasis.10From 18th century A.D. onwards Arka Kalpana, the method of extracting essence from medicinal plants, was extensively adopted in Ayurveda medicine.11 The text Arka Prakasha has mentioned that, Ardraka Arka if consumed cures Shwasa Roga.12 Since Ardraka has Ushna Virya, Vataanulomana properties and works on Kapha Dosha in Tamaka Shwasait removes the obstruction present in the Pranavaha Srotas caused by Kapha. It is also proved to have Anti-Asthmatic13 property. Arka is Shighrakari, does not vitiate Dosha and is devoid of all the Dosha.14Asthma is a condition where invasive interventions are necessary, and if not, it might result in emergency condition. Hence, it may require the continuation of consuming standard medications for children, devoiding them of standard medications would be unethical. With this backdrop, this 7study is designed to evaluate the add-on efficacy of Ardraka Arka in Tamaka Shwasa along with standard care of management

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-15
• Study Start: 2023-08-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subjects who are known cases of Bronchial Asthma /Tamaka Shwasa and are already on the treatment of modern medications.
• Subjects of age group 6-15 years irrespective of gender, religion, caste and socio-economic status.
• Subjects having clinical symptoms of Tamaka Shwasa/ Bronchial Asthma: 4.
• Subjects falling under the mild persistent, mild intermittent and moderate persistent types of bronchial asthma as per Nelson.

Exclusion Criteria

• 1.Subjects admitted to the hospital due to Asthma exacerbation within 4 weeks prior to the visit.
• 2.Any known uncontrolled systemic disease.
• 3.Severe persistent type of asthma will be excluded.
• 4.Patients with a history of any other diagnosed lung pathology.
• 5.Subjects incompatible for Spirometry evaluation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the effect of Ardraka Arka as an Add-on therapy	84 days
along with standard care on the subjective parameters of Tamaka Shwasa	84 days

Secondary Outcome Measures

Name	Time	Method
To evaluate & compare the changes in spirometry values before & after	treatment of Ardraka Arka along with the Standard care in Tamaka Shwasa.

Trial Locations

Locations (2)

JSS Ayurveda Medical College And Hospital; 🇮🇳 Mysore, KARNATAKA, India

JSS Medical College and Hospital; 🇮🇳 Mysore, KARNATAKA, India

JSS Ayurveda Medical College And Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Srihari S

Principal investigator

7776077626

dr.srihari@rediffmail.com