Respiration DisordersNCT06760286
Breathe-Easy: Food Supplement for Respiratory Health
A study testing Lung Care Solution and Support treatment in people with Respiration Disorders and Chronic Respiratory Conditions, run by Innowage Limited at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiration Disorders, Chronic Respiratory Conditions, Pulmonary Diseases or Conditions
- What is being tested?
- Lung Care Solution and Support treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIndia
- Study dates
- 12 May 2024to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acute respiratory infection within the last 30 days.
- Current participation in another clinical trial.
- History of severe adverse reactions to similar supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Lung Care Solution, Support treatment
- Keywords
- Lung Care, Breathe-Easy, Dietary supplement
- Medical subject headings
- Respiration Disorders, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Care SolutionDietary supplement
Also called Bionutriva
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.
Support treatmentOther
Participants in this group engaged in guided lifestyle modifications aimed at improving respiratory health. This included dietary recommendations as part of clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Breathe-Easy | Experimental | Lung Care Solution Receives: Dietary Supplement: Lung Care Solution |
| Support Group | Active comparator | Dietary advise according to the hospital routine clinical practice. Receives: Other: Support treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pulmonary function
Differences in forced expiratory volume measured by spirometry
Measured: Change in forced expiratory volume (FEV1) from baseline to 12 weeks.
Secondary outcomes (2)
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.
Measured: Change in symptom scores from baseline to 12 weeks.
Quality of Life (QoL)
QoL measured using the St. George's Respiratory Questionnaire (SGRQ)
Measured: Change in quality of life from baseline to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start12 May 2024
- Primary completion18 Sep 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innowage Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mettle Networks, Gyansanjeevani India
- Responsible party
- Sponsor
- Investigators
- Sandeep Shinde, Study chair, Mettle Networks, UKDr Neha Sharma, Study director, Innowage UKDr Bidyanand Jha, Study director, Lexicon MILE, IndiaDr Sadhana Sharma, Principal investigator, Gyansanjeevani IndiaDr Mridu Sharma, Study chair, Mettle Networks, UKDr. Pradyuman S Rathore, Principal investigator, Lexicon MILE, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760286
- Sponsor's protocol ID
- InnUK/MN/0119
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06760286
- Acronym / sponsor ID
- InnUK/MN/0119
- Conditions
- Respiration Disorders, Chronic Respiratory Conditions, Pulmonary Diseases or Conditions, Chronic Disease Management, Respiratory Tract Disorders
- Keywords
- Lung Care, Breathe-Easy, Dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Innowage LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Mettle Networks, Gyansanjeevani India
- Study start
- 12 May 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathe-Easy | Experimental | Dietary Supplement: Lung Care SolutionLung Care Solution |
| Support Group | Active comparator | Other: Support treatmentDietary advise according to the hospital routine clinical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Acute respiratory infection within the last 30 days.
- Current participation in another clinical trial.
- History of severe adverse reactions to similar supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Care SolutionAlso: BionutrivaParticipants 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. | Dietary supplement | Breathe-Easy |
| Support treatmentParticipants in this group engaged in guided lifestyle modifications aimed at improving respiratory health. This included dietary recommendations as part of clinical practice. | Other | Support Group |
Primary outcome
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
2 secondary outcomes
Symptom Severity Scores
Time frame: Change in symptom scores from baseline to 12 weeks.
Quality of Life (QoL)
Time frame: Change in quality of life from baseline to 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Shinde study chair
Mettle Networks, UK
Dr Neha Sharma study director
Innowage UK
Dr Bidyanand Jha study director
Lexicon MILE, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Care Solution and Support treatment in people with Respiration Disorders and Chronic Respiratory Conditions, run by Innowage Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pulmonary function (time frame: Change in forced expiratory volume (FEV1) from baseline to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.