Change in Skin Surface Temperature at the Knee Area on Both Sides When Using Mild Moxibustion Manipulation at Mingmen Acupoint With Moxa Stick

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05578027
• Other study ID #: 677/HDDD-DHYD
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Procedure:
• Mild moxibustion with moxa stick
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.

Locations

Country	Name	City	State
Vietnam	Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Bui Pham Minh Man

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skin surface temperature at the local stimulated area when using mild moxibustion manipulation at Mingmen acupoint		During procedure
Primary	Change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint		During procedure

External Links

•   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/biology10010065
•   Deng H, Shen X. The mechanism of moxibustion: ancient theory and modern research. Journal of Evidence-Based Complementary and Alternative Medicine. 2013;2013
•   Kim SY, Chae Y, Lee SM, Lee H, Park HJ. The effectiveness of moxibustion: an overview during 10 years. Evid Based Complement Alternat Med. 2011;2011:306515. doi:10.1093/ecam/nep163
•   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.
•   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.