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Completed

NCT Number: NCT06760286

Breathe-Easy: Food Supplement for Respiratory Health

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.

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Key information

Conditions

Respiration Disorders Chronic Disease Management Chronic Respiratory Conditions Lung Diseases Pulmonary Diseases or Conditions Respiratory Tract Diseases Respiratory Tract Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gyansanjeevani India

Jaipur, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Care Solution

Dietary Supplement

Participants in the Breathe-Easy group received the food supplement solution designed to improve lung health and respiratory function. The supplement includes natural ingredients known for their potential to reduce inflammation, improve oxygen utilization, and support overall lung capacity.

Participants used 1 teaspoon of the supplement, prepared as a tea decoction, twice daily.

Other names: Bionutriva

Support treatment

Other

Participants in this group engaged in guided lifestyle modifications aimed at improving respiratory health. This included dietary recommendations as part of clinical practice.

Primary outcomes

  1. Changes in pulmonary function

    Time frame: Change in forced expiratory volume (FEV1) from baseline to 12 weeks.

    Differences in forced expiratory volume measured by spirometry

Secondary outcomes

  1. Symptom Severity Scores

    Time frame: 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.

  2. Quality of Life (QoL)

    Time frame: Change in quality of life from baseline to 12 weeks.

    QoL measured using the St. George's Respiratory Questionnaire (SGRQ)

Sponsors and collaborators

Lead sponsor

Innowage Limited

Industry

Collaborators

  • Gyansanjeevani India
  • Mettle Networks

Registry information

Official study title

Breathe-Easy Study: A Community-Based Trial on the Efficacy of Lung Care Solution for Improving Lung Capacity and Symptom Relief in Respiratory Conditions

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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