Healthy VolunteersNCT05578027
Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick
A study testing Mild moxibustion with moxa stick in people with Healthy Volunteers, run by Bui Pham Minh Man at 1 site in Vietnam.
Trial summary
Moxibustion plays an important role in Traditional Medicine treatments, which treats and prevents diseases by burning a herb preparation containing Moxa (Artemisia vulgaris, Mugwort) to stimulate the meridians of human body. Moxibustion is considered a safe and effective traditional therapy. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Mild moxibustion with moxa stick
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2022to 30 Jun 2023
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females were individual age between enough 18 and 30 years old.
- BMI: 18.5 - 23 kg/m2
- Mental alertness, good contact, cooperation with researchers.
- Had no psychiatric stress problem during moxibustion day (confirmed by answering the DASS 21 questionaire with stress point less than 15 points).
- Had no history of cardio-vascular disease, diabetes, hyperthyroidism, hypothyroidism.
- Vital sign within normal limits:
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- Heart rates from from 60 to 99 beats/minute.
- Systolic blood pressure between 90 and 139 mmHg.
- Diastolic blood pressure between 60 and 89 mmHg.
- Breathing rate: 16 ± 3 times/minute.
- Body temperature: 36.59 ± 0.43 ℃.
- SpO2 from 95 to 100%.
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
- Not currently participating in other intervention studies.
Who cannot join
- Having an inflammatory injury in the site of the skin to be investigated.
- Medical history of asthma or allergy with moxa smoke.
- Using heat therapy, for example massage, cupping therapy, acupuncture in the site of the skin to be investigated within 24 hours.
- Applying chemical or pharmaceutical products to the site of the skin to be survey before conducting the study.
- Other diseases that could affect or interfere with outcomes, including common cold or flu.
- Playing sport 2 hours before the study.
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- Taking stimulants such as beer, alcohol, coffee and tobacco within 24 hours before conducting the study.
- Skin surface temperature disorders or sensation disorders at lower-back or knee area.
- Staying up at night or having insomnia before moxibustion day.
- Women during menstruation period, pregnancy, or breastfeeding.
- Currently using certain drugs which dilate blood vessels and drop in blood pressure.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City
About this study
Official title: Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick: A Pilot Study
Moxibustion plays an important role in Traditional Medicine treatments, which treats and prevents diseases by burning a herb preparation containing Moxa (Artemisia vulgaris, Mugwort) to stimulate the meridians of human body. Moxibustion is considered a safe and effective traditional therapy. Mild moxibustion is a kind of therapeutic method which characterized by wide indications, simple manipulation and comfortable feeling, is commonly used in clinical treatment. Mingmen acupoint located on the midline of the lower back, in the depression below the spinous process of the 2nd lumbar vertebra (L2). Its indications include Yang-deficiency syndrome, Cold-Stagnation syndrome, Cold Excessive syndrome,... and it is closely related to the knee area through the path of Thoroughfare Vessel (one of the Eight Extraordinary Vessels). In our study, we investigate the change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint with moxa stick in healthy volunteers.
Read the detailed description
Participants and Methods: A randomized controlled trial is conducted by comparing the change in skin surface temperature before and after using mild moxibustion manipulation at the research acupoint (Mingmen (GV-4) acupoint) or the control acupoint (the left side Pishu (BL-20) acupoint) in healthy volunteers. A total of 38 participants will undergo 2 trial phases, corresponding to 2 times of moxibustion in 8 days, each time is 7 days apart. In the first trial phase: participants received moxibustion at left side Pishu (BL-20) acupoint. In the second trial phase: participants received moxibustion at Mingmen (GV-4) acupoint. The primary outcome was the change in skin surface temperature at the local stimulated area and the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint. This trial will be performed as a pilot study.
- Conditions
- Healthy Volunteers
- Being tested
- Mild moxibustion with moxa stick
- Keywords
- Moxibustion, Skin surface temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild moxibustion with moxa stickProcedure or surgery
To conduct this intervention, we used moxa sticks which were 1.5 cm in diameter, 13 cm long, and weighed 12 gram to perform mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) or Mingmen acupoint in 2 trial phases. The main ingredient of the moxa was dried mugwort leaf, produced in Vietnam. All moxa materials were obtained from the Sai Gon TCS Co., Ho Chi Minh City, Vietnam.
| Study group | Role | What they receive |
|---|---|---|
| Group A: P1M2 | Experimental | 19 participants received mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) and the research acupoint (Mingmen) in the first and the second trial phase, respectively. In each trial phase, skin surface temperature at the local stimulated area and the knee area on both sides will be recorded. Receives: Procedure: Mild moxibustion with moxa stick |
| Group B: M1P2 | Experimental | 19 participants received mild moxibustion manipulation at the research acupoint (Mingmen) and the control acupoint (the left side Pishu acupoint) in the first and the second trial phase, respectively. In each trial phase, skin surface temperature at the local stimulated area and the knee area on both sides will be recorded. Receives: Procedure: Mild moxibustion with moxa stick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin surface temperature at the local stimulated area when using mild moxibustion manipulation at Mingmen acupoint
Measured: During procedure
Change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single group
- Model description
- A pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bui Pham Minh Man
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578027
- Sponsor's protocol ID
- 677/HDDD-DHYD
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristic and outcome data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick: A Pilot Study
- ClinicalTrials.gov ID
- NCT05578027
- Acronym / sponsor ID
- 677/HDDD-DHYD
- Conditions
- Healthy Volunteers
- Keywords
- Moxibustion, Skin surface temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bui Pham Minh ManUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Oct 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.
Moxibustion plays an important role in Traditional Medicine treatments, which treats and prevents diseases by burning a herb preparation containing Moxa (Artemisia vulgaris, Mugwort) to stimulate the meridians of human body. Moxibustion is considered a safe and effective traditional therapy. Mild moxibustion is a kind of therapeutic method which characterized by wide indications, simple manipulation and comfortable feeling, is commonly used in clinical treatment. Mingmen acupoint located on the midline of the lower back, in the depression below the spinous process of the 2nd lumbar vertebra (L2). Its indications include Yang-deficiency syndrome, Cold-Stagnation syndrome, Cold Excessive syndrome,... and it is closely related to the knee area through the path of Thoroughfare Vessel (one of the Eight Extraordinary Vessels). In our study, we investigate the change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint with moxa stick in healthy volunteers.
Detailed description
Participants and Methods: A randomized controlled trial is conducted by comparing the change in skin surface temperature before and after using mild moxibustion manipulation at the research acupoint (Mingmen (GV-4) acupoint) or the control acupoint (the left side Pishu (BL-20) acupoint) in healthy volunteers. A total of 38 participants will undergo 2 trial phases, corresponding to 2 times of moxibustion in 8 days, each time is 7 days apart. In the first trial phase: participants received moxibustion at left side Pishu (BL-20) acupoint. In the second trial phase: participants received moxibustion at Mingmen (GV-4) acupoint. The primary outcome was the change in skin surface temperature at the local stimulated area and the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint. This trial will be performed as a pilot study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A pilot study
| Arm | Type | Receives |
|---|---|---|
| Group A: P1M2 | Experimental | Procedure: Mild moxibustion with moxa stick19 participants received mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) and the research acupoint (Mingmen) in the first and the second trial phase, respectively. In each trial phase, skin surface temperature at the local stimulated area and the knee area on both sides will be recorded. |
| Group B: M1P2 | Experimental | Procedure: Mild moxibustion with moxa stick19 participants received mild moxibustion manipulation at the research acupoint (Mingmen) and the control acupoint (the left side Pishu acupoint) in the first and the second trial phase, respectively. In each trial phase, skin surface temperature at the local stimulated area and the knee area on both sides will be recorded. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy males and females were individual age between enough 18 and 30 years old.
- BMI: 18.5 - 23 kg/m2
- Mental alertness, good contact, cooperation with researchers.
- Had no psychiatric stress problem during moxibustion day (confirmed by answering the DASS 21 questionaire with stress point less than 15 points).
- Had no history of cardio-vascular disease, diabetes, hyperthyroidism, hypothyroidism.
Key exclusion criteria (11 listed)
- Having an inflammatory injury in the site of the skin to be investigated.
- Medical history of asthma or allergy with moxa smoke.
- Using heat therapy, for example massage, cupping therapy, acupuncture in the site of the skin to be investigated within 24 hours.
- Applying chemical or pharmaceutical products to the site of the skin to be survey before conducting the study.
- Other diseases that could affect or interfere with outcomes, including common cold or flu.
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 |
|---|---|---|
| Mild moxibustion with moxa stickTo conduct this intervention, we used moxa sticks which were 1.5 cm in diameter, 13 cm long, and weighed 12 gram to perform mild moxibustion manipulation at the control acupoint (the left side Pishu acupoint) or Mingmen acupoint in 2 trial phases. The main ingredient of the moxa was dried mugwort leaf, produced in Vietnam. All moxa materials were obtained from the Sai Gon TCS Co., Ho Chi Minh City, Vietnam. | Procedure or surgery | Group A: P1M2, Group B: M1P2 |
Primary outcome
Change in skin surface temperature at the local stimulated area when using mild moxibustion manipulation at Mingmen acupoint
Time frame: During procedure
Change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint
Time frame: During procedure
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 23 Oct 2023.
- Deng H, Shen X. The mechanism of moxibustion: ancient theory and modern research. Journal of Evidence-Based Complementary and Alternative Medicine. 2013;2013Link provided by the sponsor.
- Sun C, Li Y, Kuang J, Liang X, Wu J, Ji C. The thermal performance of biological tissue under moxibustion therapy. Journal of thermal biology. 2019;83:103-111.Link provided by the sponsor.
- Coiffard B, Diallo AB, Mezouar S, Leone M, Mege JL. A Tangled Threesome: Circadian Rhythm, Body Temperature Variations, and the Immune System. Biology (Basel). Jan 18 2021;10(1)doi:10.3390/biology10010065Link provided by the sponsor.
- Yang Y, Ji L, Li G, Deng X, Cai P, Guan LJJoTCM. Differences in thermal effects of moxibustion at Zusanli (ST 36) and Hegu (LI 4) on various facial areas in healthy people. 2012;32(3):397-403.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Demographic characteristic and outcome data will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mild moxibustion with moxa stick in people with Healthy Volunteers, run by Bui Pham Minh Man at 1 site in Vietnam.
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 14 inclusion and 11 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 23 Oct 2023. 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 Vietnam. 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?
Change in skin surface temperature at the local stimulated area when using mild moxibustion manipulation at Mingmen acupoint (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.