Chinese Herbal Sachet Inhalation for Primary Dysmenorrhea in Female College Students

NCT07778849 | Completed

• 1 other identifier: FCSD/MSN-0079/2023
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Keywords

primary dysmenorrhea; menstrual pain ·; traditional Chinese medicine; herbal sachet; aromatherapy; inhalation; college students

Outcome Measures

Primary Outcomes (1)

• Change from baseline in menstrual pain intensity (Visual Analogue Scale, VAS)

  Pain rated on a 0-10 cm visual analogue scale (0 = no pain, 10 = worst imaginable pain); higher scores mean worse pain.

  Baseline and within 1 week after the end of the 9-week intervention

Secondary Outcomes (5)

• Change from baseline in Cox Menstrual Symptom Scale (CMSS) total score

  Baseline and within 1 week after the end of the 9-week intervention

• Change from baseline in Cox Menstrual Symptom Scale (CMSS) severity subscore

  Baseline and within 1 week after the end of the 9-week intervention

• Change from baseline in Cox Menstrual Symptom Scale (CMSS) duration subscore

  Baseline and within 1 week after the end of the 9-week intervention

• Change from baseline in Zung Self-Rating Anxiety Scale (SAS) standard score

  Baseline and within 1 week after the end of the 9-week intervention

• Change from baseline in Zung Self-Rating Depression Scale (SDS) standard score

  Baseline and within 1 week after the end of the 9-week intervention

Other Outcomes (1)

• Adverse reactions

  Throughout the 9-week intervention

Study Arms (2)

Herbal sachet

EXPERIMENTAL

Nightly inhalation of a Delphi-derived 13-ingredient traditional Chinese herbal sachet placed within 30 cm of the head during sleep, for 9 weeks; sachet replaced every 3 weeks; plus standard health education on primary dysmenorrhea.

Other: Traditional Chinese herbal sachet (aromatic inhalation)

Placebo sachet

PLACEBO COMPARATOR

Identical-appearing sachet containing whole-wheat flour, lily, chrysanthemum and orange-peel powder, used in exactly the same way for 9 weeks; plus the same health education.

Other: Placebo sachets

Interventions

Traditional Chinese herbal sachet (aromatic inhalation) OTHER

Approximately 95-105 g powdered blend of Angelica dahurica (Bai Zhi), Syzygium aromaticum (Ding Xiang), Artemisia argyi (Ai Ye), Foeniculum vulgare (Xiao Hui Xiang), Kaempferia galanga (Shan Nai), Cinnamomum cassia (Rou Gui), Angelica sinensis (Dang Gui), Ligusticum chuanxiong (Chuan Xiong), Cyperus rotundus (Xiang Fu), Aucklandia lappa (Mu Xiang), Rosa rugosa (Mei Gui Hua), Osmanthus fragrans (Gui Hua) and Liquidambar orientalis (Su He Xiang) in a sealed non-woven bag inside a mesh pouch, hung at the bedside within 30 cm of the nose from about 23:00 to 07:00 every night for 9 weeks; replaced every 3 weeks.

Herbal sachet

Placebo sachets OTHER

Sachet of the same size, colour and weight containing whole-wheat flour, lily powder, chrysanthemum powder and orange-peel powder, used identically to the herbal sachet.

Placebo sachet

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan Nursing Vocational College: collaborator
• Macao Polytechnic University: lead

Study Sites (1)

ichuan Nursing Vocational College

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Dysmenorrhea; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Cindy Sin U LEONG, DHSc, RN

  Macao Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Herbal and placebo sachets were matched for appearance, size and weight and prepared by the same supplier; participants were not told which sachet they received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 21, 2026
• Study Start: November 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)