Clinical trial NCT05578027: Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Moxibustion
Skin surface temperature
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A pilot study
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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:

  * 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change in skin surface temperature at the local stimulated area when using mild moxibustion manipulation at Mingmen acupoint
timeFrame: During procedure
measure: Change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Study officials:
References: