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Completed

NCT Number: NCT07799285

Suspended Moxibustion for Primary Dysmenorrhea in Female Medical Students

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).

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho University of Medicine and Pharmacy

Can Tho, Ninh Kieu, 94100, Vietnam

About this study

Primary dysmenorrhea (PD) affects up to 88.2% of female students at Can Tho University of Medicine and Pharmacy, yet fewer than 10% receive structured treatment. Moxibustion, a traditional Chinese medicine thermal therapy, has shown promise in regulating prostaglandin synthesis and improving uterine microcirculation, but no controlled study had previously evaluated a standardized moxibustion protocol in Vietnamese medical students.

Eligible participants were female students and postgraduate trainees aged 18-35 years with regular menstrual cycles (28±7 days) and a history of moderate-to-severe dysmenorrhea (VAS ≥ 4) in at least 3 consecutive cycles prior to enrolment. Exclusion criteria included secondary dysmenorrhea, neurological or bleeding disorders, use of prostaglandin synthesis inhibitors within 2 weeks of enrolment, pregnancy/lactation, and current use of NSAIDs or oral contraceptives.

Suspended moxibustion (moxa stick held 2-3 cm above skin, target skin temperature 40-45°C) was administered once daily at CV4, CV8, and bilateral SP6 for 20 minutes/session, from 7 days before menstruation through the last day of menstruation (approximately 7-10 sessions per cycle), across 3 active treatment cycles. Outcomes (VAS, RSS-COX, pain days, abdominal skin temperature) were assessed at baseline and after each of the three treatment cycles. Statistical analysis used Wilcoxon Signed-Rank tests for paired comparisons, Spearman correlation, and Kruskal-Wallis tests, with Bonferroni correction (SPSS v26).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Treatment and study plan

Suspended moxibustion at CV4, CV8, SP6

Other

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

Other names: Moxibustion group

Primary outcomes

  1. Change in Visual Analogue Scale (VAS) pain score

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

    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.

Secondary outcomes

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

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

    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.

  2. Number of pain days per menstrual cycle

    Time frame: baseline and after each of three treatment cycles

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

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

    Abdominal skin temperature was measured using a FLIR C5 thermal imaging camera to assess the vasodilatory and thermal effect of moxibustion. Temperature was recorded at three time points relative to each moxibustion session: immediately before treatment (T0), immediately after treatment (T1), and 15 minutes after treatment (T2).

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Official study title

Evaluating the Analgesic Efficacy of Suspended Moxibustion in the Treatment of Primary Dysmenorrhea in Female Students at Can Tho University of Medicine and Pharmacy

Acronym: ctump

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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