Breathe-Easy: Food Supplement for Respiratory Health

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

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.

Study Overview

• Status: Completed
• Conditions: Respiration Disorders; Respiratory Tract Disorders; Chronic Disease Management; Pulmonary Diseases or Conditions; Chronic Respiratory Conditions
• Intervention / Treatment: Dietary supplement: Lung Care Solution; Other: Support treatment

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Jaipur, India
    • Gyansanjeevani India

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breathe-Easy; Lung Care Solution	Dietary supplement: Lung Care Solution; 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
Active Comparator: Support Group; Dietary advise according to the hospital routine clinical practice.	Other: Support treatment; Participants in this group engaged in guided lifestyle modifications aimed at improving respiratory health. This included dietary recommendations as part of clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pulmonary function	Differences in forced expiratory volume measured by spirometry	Change in forced expiratory volume (FEV1) from baseline to 12 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Innowage Limited
• Collaborators: Gyansanjeevani India; Mettle Networks
• Investigators: Study Chair: Sandeep Shinde, Mettle Networks, UK; Study Director: Dr Neha Sharma, Innowage UK; Study Director: Dr Bidyanand Jha, Lexicon MILE, India; Principal Investigator: Dr Sadhana Sharma, Gyansanjeevani India; Study Chair: Dr Mridu Sharma, Mettle Networks, UK; Principal Investigator: Dr. Pradyuman S Rathore, Lexicon MILE, India

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2024
• Primary Completion (Actual): September 18, 2024
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Dietary supplement; Lung Care; Breathe-Easy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease; Respiratory Tract Diseases; Respiration Disorders; Chronic Disease
• Other Study ID Numbers: InnUK/MN/0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No