NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Macao Polytechnic University
Conditions: Primary Dysmenorrhea
Interventions: Traditional Chinese herbal sachet (aromatic inhalation), Placebo sachets
Countries: China
Primary dysmenorrhea (painful menstrual periods without an underlying disease) is very common in female college students and can affect sleep, mood, study and daily life. This study tested whether sleeping next to a traditional Chinese herbal sachet - a small cloth bag containing a standardized blend of 13 aromatic herbal materials chosen by an expert consensus (Delphi) process - reduces menstrual pain and menstrual symptoms, and improves anxiety and depression, compared with an identical-looking placebo sachet. Eighty-two female students at Sichuan Nursing Vocational College with primary dysmenorrhea were randomly assigned to the herbal sachet or the placebo sachet. Participants placed the sachet within about 30 cm of the head every night during sleep for 9 weeks, with a fresh sachet every 3 weeks; both groups received the same health education. Pain (visual analogue scale), menstrual symptoms (Cox Menstrual Symptom Scale), anxiety (Self-Rating Anxiety Scale) and depression (Self-Rating Depression Scale) were measured before and within one week after the 9-week intervention. Participants did not know which sachet they received.
Sex: FEMALE
Age: 18 Years to 25 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Female student enrolled at Sichuan Nursing Vocational College * Aged 18-25 years, unmarried and nulliparous * Meets Western and traditional Chinese medicine diagnostic criteria for primary dysmenorrhea * History of primary dysmenorrhea for more than 6 months, with pain in 3 consecutive menstrual cycles * Menstrual symptom score greater than 8, moderate or severe dysmenorrhea (VAS at least 3) * Regular menstrual cycle * No sedative, analgesic or hormonal medication in the week before enrolment, and willing not to take interfering medication during the study * Voluntary participation with signed informed consent Exclusion Criteria: * Gynaecological disease (secondary dysmenorrhea) or irregular menstrual cycle * Planning pregnancy * Other serious physical or psychiatric illness (e.g., autoimmune disease, cancer, heart disease), or conditions requiring surgery * Currently participating in another clinical trial * Unable to complete the study period
- Chengdu, Sichuan, China