Effect of Indoor Plants on Cardiopulmonary System

July 24, 2024 updated by: Lina Zhang

Effect of Indoor Plants on Cardiopulmonary System: a Randomized, Crossover, Controlled Trial

This is a randomized controlled human exposure crossover study, aims to explore the health benefits of indoor plants on cardiopulmonary system on adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The researchers will conduct a randomized cross-controlled trial involving 48 healthy adults in Hangzhou, China. These participants will be randomly assigned into two groups, each comprising 24 individuals. Each participant will undergo two separate exposures in an office setting: one exposure without any plants present, and another exposure with 34 to 38 potted plants. A washout period of at least 4 weeks will be implemented between the two exposures. Questionnaires, physical examinations and the collection of biological samples will be conducted prior to exposure and after exposure. In addition, the monitoring of negative air ion, air pollutants and noise exposure, as well as collection of environmental microbial samples, will be conducted on weekdays. Researchers will gather samples of blood, urine, nasal secretion, and exhaled breath condensate from participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Huangzhou, Zhejiang, China, 310000
        • Zhejiang Chinese Medicine University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Living in Hangzhou during the study period;
  • Non-smoking, no history of alcohol or drug abuse;
  • Staying indoors in daytime we required.

Exclusion Criteria:

  • Current or ever smokers;
  • Subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy;
  • Subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension;
  • Subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
  • Subjects with chronic disease, such as diabetes, chronic hepatitis, and kidney disease;
  • Subjects with a history of major surgery;
  • Medication use or dietary supplements intake in recent two months;
  • Unable to cooperate with follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Plants placed in an office environment
Participants in this group will receive an intervention of plants placed in an office environment.
Other: Plants placed in an office environment
The intervention group will be provided with an intervention consisting of 34-38 potted plants arranged in an office environment for a duration of 8 hours (09:00-17:00) on weekdays (Monday to Friday) for 4 weeks.
Active Comparator: Devoid of any plant presence in an office environment
Participants in this group will be exposed to an office environment devoid of any plant presence.
Other: Devoid of any plant presence in an office environment
Participants assigned to the control group will be exposed to an office environment devoid of any plant presence for a duration of 8 hours (09:00-17:00) on weekdays (Monday to Friday) for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity(FVC)
Time Frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
We plan to measure forced vital capacity (FVC) of lung function.
Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Pressure(BP)
Time Frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
We plan to measure systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
Heart Rate Variability(HRV)
Time Frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
We plan to measure Heart Rate Variability (HRV).
Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
C-reactive protein(CRP)
Time Frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
We plan to measure serum concentrations of C-reactive protein(CRP)
Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
Interleukin-6(IL-6)
Time Frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
We plan to measure the serum concentrations of Interleukin-6
Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
Tumor necrosis factor-α(TNF-α)
Time Frame: Time Frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.
We plan to measure the serum concentrations of Tumor necrosis factor-α
Time Frame: Baseline and after 4 weeks plants exposure in first stage, and after washout period, baseline and after 4 weeks plants exposure in second stage.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lina Zhang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Chinese Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lina Zhang, Ph.D, School of Public Health, Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230922-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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