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

NCT05578027 | Completed

• 1 other identifier: 677/HDDD-DHYD
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Moxibustion; Skin surface temperature

Outcome Measures

Primary Outcomes (2)

• Change in skin surface temperature at the local stimulated area when using mild moxibustion manipulation at Mingmen acupoint

  During procedure

• Change in skin surface temperature at the knee area on both sides when using mild moxibustion manipulation at Mingmen acupoint

  During procedure

Study Arms (2)

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.

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.

Procedure: Mild moxibustion with moxa stick

Interventions

Mild moxibustion with moxa stick PROCEDURE

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.

Group A: P1M2; Group B: M1P2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bui Pham Minh Man: lead

Study Sites (1)

Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City

Ho Chi Minh City, Vietnam

Location

Related Links

• Deng H, Shen X. The mechanism of moxibustion: ancient theory and modern research. Journal of Evidence-Based Complementary and Alternative Medicine. 2013;2013
• 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.
• 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
• 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.

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Model Details: A pilot study

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: October 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

VN (1)