Role of Herbs in the Management of Asthma
- Conditions
- Health Condition 1: null- Bronchial Asthma
- Registration Number
- CTRI/2016/10/007376
- Lead Sponsor
- Organic India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
1. Adults aged >= 18 years.
2. History of asthma documented by a physician for at least 6 months
3. Patients on steroid therapy for at least 4 weeks.
4. If not on steroid therapy, patient and physician must be willing for 4 weeks run in on steroid therapy.
5. The subject agrees to participate in the study
Any one of the following
1. Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
2. Abnormal hepatic and renal function
3. Pregnant, attempting to conceive, or lactating women
4. Current or former employees of organic India
5. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
6. Physician uncomfortable with patient compliance to treatments or follow up.
7. Non-compliance to tobacco cessation therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline <br/ ><br>2. Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baselineTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Frequency of asthma exacerbation per weekTimepoint: 6 months