Breathe-Easy: Food Supplement for Respiratory Health

Not Applicable

Completed

• Conditions: Respiration Disorders; Chronic Respiratory Conditions; Pulmonary Diseases or Conditions; Chronic Disease Management; Respiratory Tract Disorders

• Registration Number: NCT06760286
• Lead Sponsor: Innowage Limited

Brief Summary

The trial aims to assess the effectiveness of a natural lung care solution and a food supplement in improving lung function, capacity, and alleviating symptoms associated with respiratory conditions like asthma, COPD, and chronic bronchitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-12
• Primary Completion: 2024-09-18
• Study Completion: 2024-11-12
• Status Verified: 2024-12
• Study First Submitted: 2024-12-30
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Adults aged 18 and older.
• Diagnosed with a chronic respiratory condition (e.g., asthma, COPD).
• No known allergies to ingredients in the supplement.
• Ability to provide informed consent and comply with study procedures.

Exclusion Criteria

• Acute respiratory infection within the last 30 days.
• Current participation in another clinical trial.
• History of severe adverse reactions to similar supplements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in pulmonary function	Change in forced expiratory volume (FEV1) from baseline to 12 weeks.	Differences in forced expiratory volume measured by spirometry

Secondary Outcome Measures

Name	Time	Method
Symptom Severity Scores	Change in symptom scores from baseline to 12 weeks.	Symptom severity assessed to measure the impact of the interventions on respiratory symptoms such as shortness of breath, coughing, wheezing, and chest tightness.
Quality of Life (QoL)	Change in quality of life from baseline to 12 weeks.	QoL measured using the St. George's Respiratory Questionnaire (SGRQ)

Trial Locations

Locations (1)

Gyansanjeevani India; 🇮🇳 Jaipur, India