MedPath

To compare Drug Utilization and effects between Ayurveda and Allopathy treatment in patients with Bronchial Asthma.

Recruiting
Conditions
Moderate persistent asthma,
Registration Number
CTRI/2019/10/021481
Lead Sponsor
NA
Brief Summary

This is a prospective observational study which compares theDrug Utilization patterns and effects in Ayurveda and Conventional treatment inpatients with Bronchial Asthma which will be conducted in India in KasturbaHospital, Manipal in a minimum of 250 patients for the approved duration ofstudy. The primary objective of this study is to study the Drug Utilization patternsand effects of therapy in Ayurveda and Conventional treatment in patients withBronchial Asthma and the secondary objective of this study is to study theQuality of Life among Bronchial Asthma patients along with assessment of directcost of therapy per patient. The drug utilization patterns will be comparedamong patients of out-patient department in Ayurveda and Respiratory medicine separately.The information obtained will be noted in a suitable designed CRF. Follow-upwill be done on the visit or by contacting the patient. The Quality of lifewill be measured using Asthma Quality of Life Questionnaire (AQLQ), astandardized widely available and validated instrument to assess quality oflife in Asthmatic patients. Efficacy will be assessed according to the domainsin the Quality of Life Questionnaire. As a routine investigation, the directcost burden will be compared between both the therapies and will also becalculated for every patient. The confidentiality of the patient data collectedwill be duly respected and the name of the patient will not be noted under anycircumstance.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
250
Inclusion Criteria

Out patients visiting the Respiratory and Ayurveda departments.

Exclusion Criteria
  • Patients with cardiovascular disease (Cardiac arrest, Arrhythmia, Congenital Heart Disease, Stroke).
  • Patients with hepatic and renal impairment.
  • Pregnant and lactating women.
  • Patients with neurological impairment.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Drug utilization patterns and effects of treatment in patients with Bronchial Asthma will be assessed.Data will be collected for 12 months which will be followed by organizing and analysis of the data collected for 2 months and then 1 month will be used to prepare a report.
Secondary Outcome Measures
NameTimeMethod
Quality of life of patients will be assessed along with the direct cost of therapy per patient.Data will be collected for 12 months which will be followed by organizing and analysis of the data collected for 2 months and then 1 month will be used to prepare a report.

Trial Locations

Locations (1)

KASTURBA HOSPITAL, MANIPAL

🇮🇳

Udupi, KARNATAKA, India

KASTURBA HOSPITAL, MANIPAL
🇮🇳Udupi, KARNATAKA, India
ANANYA A NAYAK
Principal investigator
7975827672
an17.ananya@gmail.com

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