NCT07799285

Brief Summary

This study evaluates the analgesic efficacy of suspended moxibustion applied at acupoints CV4 (Guanyuan), CV8 (Shenque), and bilateral SP6 (Sanyinjiao) in female students with primary dysmenorrhea at Can Tho University of Medicine and Pharmacy. In this single-arm pre-post clinical intervention (N=48), participants received daily 20-minute moxibustion sessions starting 7 days before menstruation through the end of the menstrual period, across three consecutive treatment cycles. The primary outcome was change in VAS pain score; secondary outcomes included RSS-COX symptom burden, number of pain days per cycle, and abdominal skin temperature measured by thermal imaging (FLIR C5).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 24, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

moxibustion; suspended moxibustion; acupoint; CV4; CV8; SP6; primary dysmenorrhea; traditional Chinese medicine; pain; medical students; Vietnam

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analogue Scale (VAS) pain score

    The Cox Menstrual Symptom Scale (RSS-COX) is a validated self-report instrument measuring the frequency and severity of menstrual-related systemic symptoms, including back pain, fatigue, irritability, and headache. Higher scores indicate greater symptom burden.

    Baseline and at the end of Cycle 1, Cycle 2, and Cycle 3 (each menstrual cycle is approximately 28 days)

Secondary Outcomes (3)

  • Change in RSS-COX (Cox Menstrual Symptom Scale) symptom burden score

    Baseline and at the end of Cycle 1, Cycle 2, and Cycle 3 (each menstrual cycle is approximately 28 days)

  • Number of pain days per menstrual cycle

    baseline and after each of three treatment cycles

  • Abdominal skin temperature (measured by FLIR C5 thermal imaging camera)

    Immediately before (T0), immediately after (T1), and 15 minutes after (T2) each moxibustion session, assessed throughout Cycles 1 to 3

Study Arms (1)

Moxibustion group

EXPERIMENTAL

All 48 participants received suspended moxibustion at CV4, CV8, and bilateral SP6 for 20 minutes daily, from 7 days before menstruation through the end of the menstrual period, across three consecutive treatment cycles.

Other: Suspended moxibustion at CV4, CV8, SP6

Interventions

Moxa stick suspended 2-3 cm above the skin at acupoints CV4 (Guanyuan), CV8 (Shenque), and bilateral SP6 (Sanyinjiao), targeting a skin temperature of 40-45°C, administered once daily for 20 minutes p

Also known as: Moxibustion group
Moxibustion group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInclusion Criteria: Aged 18-35 years with a regular menstrual cycle (28 ± 7 days) History of moderate-to-severe dysmenorrhea (VAS ≥ 4) in at least 3 consecutive menstrual cycles prior to enrolment Willing to participate and providing written informed consent Exclusion Criteria: Secondary dysmenorrhea attributable to endometriosis, pelvic inflammatory disease, or uterine fibroids (confirmed by abdominal ultrasound) Neurological disorders, immunodeficiency, or uncontrolled bleeding disorders Any systemic medical condition contraindicating moxibustion Use of prostaglandin synthesis inhibitors (PGSIs) within two weeks prior to enrolment Pregnancy, lactation, or planned pregnancy within the following 6 months Current use of NSAIDs or oral contraceptives Ongoing or recent moxibustion treatment within 2 weeks prior to registration
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-35 years with a regular menstrual cycle (28 ± 7 days)
  • History of moderate-to-severe dysmenorrhea (VAS ≥ 4) in at least 3 consecutive menstrual cycles prior to enrolment
  • Willing to participate and providing written informed consent

You may not qualify if:

  • Secondary dysmenorrhea attributable to endometriosis, pelvic inflammatory disease, or uterine fibroids (confirmed by abdominal ultrasound)
  • Neurological disorders, immunodeficiency, or uncontrolled bleeding disorders
  • Any systemic medical condition contraindicating moxibustion
  • Use of prostaglandin synthesis inhibitors (PGSIs) within two weeks prior to enrolment
  • Pregnancy, lactation, or planned pregnancy within the following 6 months
  • Current use of NSAIDs or oral contraceptives
  • Ongoing or recent moxibustion treatment within 2 weeks prior to registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, Ninh Kieu, 94100, Vietnam

Location

MeSH Terms

Conditions

Pain

Interventions

arginyl-threonyl-prolyl-prolyl-prolyl-seryl-glycine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • lan ngoc chi nguyen

    Faculty of Traditional Medicine, Can Tho University of Medicine and Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 2, 2026

Study Start

December 1, 2025

Primary Completion

July 1, 2026

Study Completion

July 20, 2026

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in this article (VAS pain scores, RSS-COX scores, pain days, and abdominal skin temperature measurements) will be made available to researchers who provide a methodologically sound proposal, beginning 6 months and ending 3 years after publication. Requests should be directed to the corresponding author. Data will be shared after approval of a data access request by the study team.

Shared Documents
ICF, CSR
Time Frame
Data will be available beginning 6 months after publication and ending 3 years after publication.
Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims approved by the study team. Proposals should be directed to the corresponding author. Requestors will need to sign a data access agreement.

Locations