Breathe-Easy: Food Supplement for Respiratory Health

NCT06760286 | Completed DMC

• 1 other identifier: InnUK/MN/0119
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Lung Care; Breathe-Easy; Dietary supplement

Outcome Measures

Primary Outcomes (1)

• Changes in pulmonary function

  Differences in forced expiratory volume measured by spirometry

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

Secondary Outcomes (2)

• Symptom Severity Scores

  Change in symptom scores from baseline to 12 weeks.

• Quality of Life (QoL)

  Change in quality of life from baseline to 12 weeks.

Study Arms (2)

Breathe-Easy

EXPERIMENTAL

Lung Care Solution

Dietary Supplement: Lung Care Solution

Support Group

ACTIVE COMPARATOR

Dietary advise according to the hospital routine clinical practice.

Other: Support treatment

Interventions

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.

Also known as: Bionutriva

Breathe-Easy

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.

Support Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Innowage Limited: lead
• Mettle Networks: collaborator
• Gyansanjeevani India: collaborator

Study Sites (1)

Gyansanjeevani India

Jaipur, India

Location

MeSH Terms

Conditions

Respiration Disorders; Lung Diseases

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Sandeep Shinde

  Mettle Networks, UK

  STUDY CHAIR

• Dr Neha Sharma

  Innowage UK

  STUDY DIRECTOR

• Dr Bidyanand Jha

  Lexicon MILE, India

  STUDY DIRECTOR

• Dr Sadhana Sharma

  Gyansanjeevani India

  PRINCIPAL INVESTIGATOR

• Dr Mridu Sharma

  Mettle Networks, UK

  STUDY CHAIR

• Dr. Pradyuman S Rathore

  Lexicon MILE, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: May 12, 2024
• Primary Completion: September 18, 2024
• Study Completion: November 12, 2024
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

IN (1)