Efficacy and Safety of Beta-glucan Supplement in Chronic Obstructive Pulmonary Disease Patients

NCT ID: NCT05878834

Last Updated: 2023-05-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-25

Study Completion Date

2023-12-20

Brief Summary

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The objectives of this study are to evaluate Efficacy and safety of beta-glucan supplement in chronic obstructive pulmonary disease patients.

Detailed Description

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There are 72 patients in this study. They are randomly divided into 2 groups which are beta-glucan supplement group and placebo group. The supplement will be taken 1 capsule/day for 12 weeks. Forced expiratory volume in 1 second/Forced vital capacity, Modified Medical Research Council Dyspnea Score, Breathlessness, Cough, and Sputum Scale, 6 Minute Walk Test, Diffusing capacity for carbon monoxide, Tumor necrosis factor alpha, Interleukin-6, C-reactive protein, glutathione, aspartate transaminase, alanine transaminase, alkaline phosphatase, creatinine, and blood urea nitrogen are assessed before and after taking supplement 6 and 12 weeks.

Conditions

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Chronic Obstructive Pulmonary Disease Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Beta-glucan supplement group

Beta-glucan supplement capsule composes of beta-glucan 250 mg, broccoli 75 mg, quercetin 50 mg.

Group Type EXPERIMENTAL

Beta-glucan supplement group

Intervention Type DIETARY_SUPPLEMENT

Take 1 capsule 1 time per day for 12 weeks.

Placebo group

Placebo capsule is empty capsule.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

Take 1 capsule 1 time per day for 12 weeks.

Interventions

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Beta-glucan supplement group

Take 1 capsule 1 time per day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo group

Take 1 capsule 1 time per day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age more than 18 years
* Chronic Obstructive Pulmonary Disease with Forced expiratory volume in 1 second/Forced vital capacity after receiving bronchodilator medicine more than 70%
* No exacerbation and uncontrolled disease
* 10 pack-years smoking history 10 pack-years but stop smoking more than 1 years
* Willing to participate in this study

Exclusion Criteria

* Respiratory infection in 4 weeks
* Lung cancer
* Liver disease or kidney disease
* Lung surgery history
* Take kung supplement in 2 weeks
* Take warfarin, clopidogrel, aspirin, or digoxin
* Allergic to beta-glucan, broccoli, or quercetin
* Cannot use Spirometry
* Pregnancy and lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pornanong Aramwit, Professor

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Central Contacts

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Pornanong Aramwit, Professor

Role: CONTACT

+66899217255

Other Identifiers

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Oh87/65

Identifier Type: -

Identifier Source: org_study_id

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