Effectiveness And Safety Of Triamcinolone Tablet In Management of Acute Exacerbations Of Asthma
- Conditions
- Health Condition 1: J459- Other and unspecified asthma
- Registration Number
- CTRI/2022/12/048252
- Lead Sponsor
- Dr. S. Balamurugan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Patients of either sex in the age group of =18-=65 years.
2.Previously diagnosed case of bronchial asthma for at least 6 months, before the screening date.
3.A primary diagnosis of mild to moderate acute exacerbation of asthma (with symptoms of shortness of breath, frequent or recurrent cough, wheezing, mucus production, and/ or tightness in the chest) on presentation.
4.Patients on a stable dose of asthma medications for at least 3 months, before the screening date.
5.No other acute pathology complicating the present condition i.e. cardiac, metabolic, or any other respiratory causes.
6.Patients willing to participate in the study and sign an informed consent form.
A patient will be excluded from the study if they meet any of the following criteria:
1.Patients with a smoking history of more than 10 packs a year.
2.Patients with a history of Alcohol consumption.
3.Patients treated with oral or parenteral steroids for >5 days in the past 30-days.
4.Patients treated with theophylline =5-days, before the screening date.
5.Patients having uncontrolled diabetes or uncontrolled hypertension.
6.Patients having active tuberculosis.
7.Patients on regular Rifampicin, Phenytoin, or Phenobarbitone.
8.Pregnant and nursing women.
9.Women with childbearing potential who are not practicing a reliable method of birth control.
10.Patients with a known history of hypersensitivity to triamcinolone.
11.Suspected inability or unwillingness to comply with study procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To evaluate the effectiveness of triamcinolone oral tablets adjunct to standard of care (SOC) treatment in managing mild to moderate acute exacerbations of asthma symptoms, assessed by asthma control questionnaire-6 (ACQ-6) in routine outpatient clinical settings.Timepoint: Day 0 and 7
- Secondary Outcome Measures
Name Time Method 1.To evaluate the effectiveness of triamcinolone oral tablets adjunct to SOC treatment in improving lung function in patients with mild to moderate acute exacerbations of asthma, in routine outpatient clinical settingsTimepoint: Day 0 and 7