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Flavonoid

Quercetin for COPD (polyphenols Trial)

Phase 2

Recruiting

Led By Nathaniel Marchetti

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Both active and ex-smokers with at least 10 pack-years history of smoking

COPD patients taking H2 antagonists, loperamide or loratadine and willing to stop during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Awards & highlights

polyphenols Trial Summary

This trial looks at how quercetin supplementation affects inflammation and oxidative stress in COPD patients. 8 took 1000mg, 8 500mg and 4 placebo.

Who is the study for?

This trial is for COPD patients aged 40-80 with a specific lung function profile, who have smoked at least the equivalent of 10 pack-years. Participants must not have certain infections or be on conflicting medications, and women of childbearing age must use contraception or abstain.Check my eligibility

What is being tested?

The study tests if quercetin, a dietary supplement, can reduce inflammation and oxidative stress in COPD patients. It's a small-scale trial where participants are given either high-dose (1000 mg/day), low-dose (500 mg/day) quercetin, or placebo.See study design

What are the potential side effects?

Quercetin may cause side effects such as headaches and tingling sensations. Since it's being tested for its anti-inflammatory properties, allergic reactions could occur in those sensitive to it.

polyphenols Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have smoked at least 10 packs of cigarettes a year.

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I am willing to stop taking my COPD medications like H2 antagonists, loperamide, or loratadine during the study.

polyphenols Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

C-reactive protein (CRP), and surfactant protein (SP)-D in serum

Club cell protein 16 (CC16) pg/ml

Secondary outcome measures

Quercetin

polyphenols Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Quercetin 1000 mg/dayActive Control1 Intervention

Quercetin 1000 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally twice daily, one half dose (1 caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.

Group II: Quercetin 500mg/dayActive Control1 Intervention

Quercetin 500 mg/day Quercetin is provided as caplet and each caplet will have 500 mg of quercetin Quercetin will be administered orally once daily, (1 caplet) in the morning after breakfast and matching placebo in the evening after dinner for six months. The placebo is added to match the number of caplets with 1000 mg/day arm

Group III: PlaceboPlacebo Group1 Intervention

Placebo is also provided as caplets that is similar to quercetin in color, taste and texture and will contain all the stabilizers and the inactive ingredients that is present in the quercetin chews. Placebo will be administered orally twice daily, one half dose (1caplet) in the morning after breakfast and one half dose (1 caplet) in the evening after dinner for six months.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Temple UniversityLead Sponsor

297 Previous Clinical Trials

82,943 Total Patients Enrolled

4 Trials studying Emphysema

3,149 Patients Enrolled for Emphysema

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,820 Total Patients Enrolled

8 Trials studying Emphysema

1,309 Patients Enrolled for Emphysema

National Center for Complementary and Integrative Health (NCCIH)NIH

833 Previous Clinical Trials

669,423 Total Patients Enrolled

2 Trials studying Emphysema

36 Patients Enrolled for Emphysema

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age ceiling for enrollment in this trial?

"This clinical trial is looking for volunteers aged 40 and over, but under the age of 80."

Answered by AI

What are the qualifications for participating in this medical experiment?

"This medical research requires 30 people with chronic obstructive pulmonary disease aged between 40 and 80 to sign up."

Answered by AI

Does the FDA sanction Quercetin consumption up to 1000 mg/day?

"Quercetin 1000 mg/day has been given a value of 2 on our team's scale, as there is evidence supporting its safety but no data that confirms efficacy."

Answered by AI

Are there any openings for participation in this experiment?

"This study, which was originally posted on September 1st 2023 and edited lastly on August 15th 2023, is no longer recruiting patients. However, clinicaltrials.gov reports that there are 370 other studies actively seeking participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biological Effects of Quercetin in COPD Phase II

Umadevi Sajjan 2023. "Biological Effects of Quercetin in COPD Phase II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003270.

All > Emphysema