Breathe-Easy: Food Supplement for Respiratory Health

NCT ID: NCT06760286

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-12

Study Completion Date

2024-11-12

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Breathe-Easy

Lung Care Solution

Group Type EXPERIMENTAL

Lung Care Solution

Intervention Type 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.

Support Group

Dietary advise according to the hospital routine clinical practice.

Group Type ACTIVE_COMPARATOR

Support treatment

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Other Intervention Names

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Bionutriva

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mettle Networks

UNKNOWN

Sponsor Role collaborator

Gyansanjeevani India

UNKNOWN

Sponsor Role collaborator

Innowage Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandeep Shinde

Role: STUDY_CHAIR

Mettle Networks, UK

Dr Neha Sharma

Role: STUDY_DIRECTOR

Innowage UK

Dr Bidyanand Jha

Role: STUDY_DIRECTOR

Lexicon MILE, India

Dr Sadhana Sharma

Role: PRINCIPAL_INVESTIGATOR

Gyansanjeevani India

Dr Mridu Sharma

Role: STUDY_CHAIR

Mettle Networks, UK

Dr. Pradyuman S Rathore

Role: PRINCIPAL_INVESTIGATOR

Lexicon MILE, India

Locations

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Gyansanjeevani India

Jaipur, , India

Site Status

Countries

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India

Other Identifiers

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InnUK/MN/0119

Identifier Type: -

Identifier Source: org_study_id

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