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Role of Herbs in the Management of Asthma

Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007376
Enrollment
120
Registered
2016-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bronchial Asthma

Interventions

Intervention1: s: s Intervention2: Active poly herbal capsule and Formoterol/Fluticasone Single Maintence and Reliever therapy(SMART) therapy: Each poly herbal contains four herbs: Inula racemosa, Oci

Sponsors

Organic India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline 2. Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baselineTimepoint: 6 months

Secondary

MeasureTime frame
Frequency of asthma exacerbation per weekTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Sindhu N

Organic India

drsanjayachauhan49@gmail.com9611252350

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026