An interventional study of Acupuncture in Healthy Volunteers, sponsored by Bui Pham Minh Man. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Bui Pham Minh Man · Not applicable, Interventional, and Basic science
Acupuncture is a treatment method since ancient times and it has been recognized as an international treatment method by the World Health Organization. Although the structure and physiological effects of acupoints have been extensively studied, they have not been fully elucidated. A lot of studies on physiological effects of acupoints on the 12 main merdians have been published, but acupoints outside the meridians or acupoints on the eight extraordinary vessels have not been noticed. In particular, the Dazhui is one of the acupoints on the Du Merdian that is often used clinically. In the other side, several researches have shown that using different acupuncture manipulations can achieve different therapeutic effects. In our study, we want to determinate and compare the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations or dispersing acupuncture manipulations at Dazhui in healthy volunteers.
Participants and Methods: A pilot study is conducted by comparing the change in skin surface temperature before and after using sham or tonifying or dispersing acupuncture manipulations at EX-B2 T3 in right side and Dazhui in heatlhy volunteers. A total of 57 participants will be randomly divided into 3 groups (group STD, group TDS and group DST). Each group has 19 participants and undergo 3 trial phases, corresponding to 3 times of acupuncture in 14 days, each time is 7 days apart. For group STD, the first trial phase: participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture; the second trial phase: participants received acupuncture with tonifying manipulations at Dazhui point and tonifying manipulations was replaced by dispersing ones in the third trial phase. For group TDS, the first trial phase: participants received acupuncture with tonifying manipulations at Dazhui point; the second trial phase: participants received acupuncture with dispersing manipulations at Dazhui point and participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture in the third trial phase. Similarly, for group DST, the first trial phase: participants received acupuncture with dispersing manipulations at Dazhui point; the second trial phase: participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture and sham acupuncture was replaced byacupuncture with tonifying manipulations at Dazhui in the third trial phase. The primary outcome was the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying or dispersing acupuncture manipulations at Dazhui point. This trial will be performed as a pilot study.
Bui Pham Minh Man is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Vital sign within normal limits:
Exclusion Criteria:
19 participant received sham acupuncture at EX-B2 T3 point in right side or acupuncture with tonyfying or dispersing manipulations at Dazhui point, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at EX-B2 T3 point in right side as sham acupoint in the first trial phase. We used the same type of acupuncture needles as aboved to acupuncture at Dazhui with tonifying manipulations in the second trial phase and with dispersing manipulatiuons in the third trial phase.
Procedure: Acupuncture
19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase.
Procedure: Acupuncture
19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase.
Procedure: Acupuncture
To conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture the sham acupoint (EX-B2 T3 point) or Dazhui point.
Change temperature of skin surface at at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations at Dazhui
Time frame: During procedure
Change temperature of skin surface at at the acupuncture site, the neck and the face when using dispersing acupuncture manipulations at Dazhui
Time frame: During procedure
Plan to share: Yes — Demographic characteristic and outcome data will be shared
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Bui Pham Minh Man