MeridiansNCT05330403
The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians
A study testing Moxibustion in people with Meridians, run by Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Meridians
- What is being tested?
- Moxibustion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2019to 30 Dec 2021
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Had recent medical examination records confirming the absence of cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological diseases
- 20 ≤ age ≤ 40 years, male or female
- Had the ability to communicate with others normally
- An understanding of the entire study protocol
- Signed written informed consent
Who cannot join
- Had mental illnesses, severe depression, alcohol dependence or a history of drug abuse
- Pregnant or lactating
- Were participating in other trials
Trial locations and contacts
1 site in 1 country.
China1 site
the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, 310000
About this study
Official title: The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians With Infrared Thermography
Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes. Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study was designed to assess the heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermography. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.
Read the detailed description
80 eligible subjects were finally included. Among them, 40 participants were assigned to the lung meridian intervention group, and 40 participants were assigned to the heart meridian intervention group. All 80 participants completed the trial.
- Conditions
- Meridians
- Being tested
- Moxibustion
- Keywords
- heart and lung meridians, site specificity, infrared thermography, moxibustion, thermal transport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionProcedure or surgery
In this study, suspended moxibustion was performed by holding an ignited moxa stick at a certain distance (about 3-4 cm) over the skin surface, keeping the moxibustion Site warm without burning the skin.
In the heart meridian intervention group, moxibustion was applied over Site 4 (HT3) of the heart meridian.
In the lung meridian intervention group, moxibustion was performed over Site 1 (LU5) of the lung meridian.
| Study group | Role | What they receive |
|---|---|---|
| the lung meridian intervention group | Experimental | moxibustion intervention was performed over Site 1 (LU5) of the lung meridian Receives: Procedure: Moxibustion |
| the heart meridian intervention group | Experimental | moxibustion intervention was applied over Site 4 (HT3) of the heart meridian Receives: Procedure: Moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature change of relevant sites
Infrared thermal imaging was used to record baseline temperature and the temperature change of corresponding sites along the Heart and Lung meridians.
Measured: Baseline, Moxibustion 5 min, Moxibustion 10 min, Moxibustion 15 min, 5 minutes after stopping moxibustion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start30 Apr 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeridiansStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Responsible party
- Principal investigator, Jianqiao Fang, Zhejiang Chinese Medical University
- Investigators
- Jianqiao Fang, Ph.D, Principal investigator, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330403
- Sponsor's protocol ID
- 2019ZY010-MERIDIAN
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Jiang Y, Hu H, Lou J, Zhang Y, He X, Wu Y, Fang J, Shao X, Fang J. The Moxibustion-Induced Thermal Transport Effect Between the Heart and Lung Meridians With Infrared Thermography. Front Cardiovasc Med. 2022 May 13;9:817901. doi: 10.3389/fcvm.2022.817901. eCollection 2022.
PubMed 35647050
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Moxibustion-Induced Thermal Transport Effect Between The Heart And Lung Meridians With Infrared Thermography
- ClinicalTrials.gov ID
- NCT05330403
- Acronym / sponsor ID
- 2019ZY010-MERIDIAN
- Conditions
- Meridians
- Keywords
- heart and lung meridians, site specificity, infrared thermography, moxibustion, thermal transport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Collaborators
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 15 Apr 2022 (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.
Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes. Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study was designed to assess the heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermography. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.
Detailed description
80 eligible subjects were finally included. Among them, 40 participants were assigned to the lung meridian intervention group, and 40 participants were assigned to the heart meridian intervention group. All 80 participants completed the trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the lung meridian intervention group | Experimental | Procedure: Moxibustionmoxibustion intervention was performed over Site 1 (LU5) of the lung meridian |
| the heart meridian intervention group | Experimental | Procedure: Moxibustionmoxibustion intervention was applied over Site 4 (HT3) of the heart meridian |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Had recent medical examination records confirming the absence of cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological diseases
- 20 ≤ age ≤ 40 years, male or female
- Had the ability to communicate with others normally
- An understanding of the entire study protocol
- Signed written informed consent
Key exclusion criteria (3 listed)
- Had mental illnesses, severe depression, alcohol dependence or a history of drug abuse
- Pregnant or lactating
- Were participating in other trials
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 |
|---|---|---|
| MoxibustionIn this study, suspended moxibustion was performed by holding an ignited moxa stick at a certain distance (about 3-4 cm) over the skin surface, keeping the moxibustion Site warm without burning the skin. In the heart meridian intervention group, moxibustion was applied over Site 4 (HT3) of the heart meridian. In the lung meridian intervention group, moxibustion was performed over Site 1 (LU5) of the lung meridian. | Procedure or surgery | the heart meridian intervention group, the lung meridian intervention group |
Primary outcome
Temperature change of relevant sites
Time frame: Baseline, Moxibustion 5 min, Moxibustion 10 min, Moxibustion 15 min, 5 minutes after stopping moxibustion
Infrared thermal imaging was used to record baseline temperature and the temperature change of corresponding sites along the Heart and Lung meridians.
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 18 Apr 2022.
- Derived from this study: PubMed 35647050Li X, Jiang Y, Hu H, Lou J, Zhang Y, He X, Wu Y, Fang J, Shao X, Fang J. The Moxibustion-Induced Thermal Transport Effect Between the Heart and Lung Meridians With Infrared Thermography. Front Cardiovasc Med. 2022 May 13;9:817901. doi: 10.3389/fcvm.2022.817901. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Jianqiao Fang, Ph.D principal investigator
Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxibustion in people with Meridians, run by Zhejiang Chinese Medical University at 1 site in China.
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 5 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 18 Apr 2022. 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 China. 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?
Temperature change of relevant sites (time frame: Baseline, Moxibustion 5 min, Moxibustion 10 min, Moxibustion 15 min, 5 minutes after stopping moxibustion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05330403, which also lists 1 linked publication.
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 18 Apr 2022.