Primary DysmenorrheaNCT07778849
Chinese Herbal Sachet Inhalation for Primary Dysmenorrhea in Female College Students
A study testing Traditional Chinese herbal sachet (aromatic inhalation) in people with Primary Dysmenorrhea, run by Macao Polytechnic University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Traditional Chinese herbal sachet (aromatic inhalation)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Delphi-Derived Traditional Chinese Herbal Sachet on Pain, Menstrual Symptoms, Anxiety and Depression in Female College Students With Primary Dysmenorrhea: A Randomized, Single-Blind, Placebo-Controlled Trial
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.
Read the detailed description
Design: single-centre, randomized, single-blind (participant), placebo-controlled, two-arm parallel-group trial.
Randomization: participants were numbered in order of recruitment and allocated 1:1 using a computer-generated random number table (SPSS).
Intervention: herbal sachet containing Angelica dahurica root 5 g, Syzygium aromaticum flower bud 5 g, Artemisia argyi leaf 5 g, Foeniculum vulgare fruit 5 g, Kaempferia galanga rhizome 5 g, Cinnamomum cassia bark 10 g, Angelica sinensis root 10 g, Ligusticum chuanxiong rhizome 10 g, Cyperus rotundus rhizome 10 g, Aucklandia lappa root 10 g, Rosa rugosa flower bud 15 g, Osmanthus fragrans flower 15 g and Liquidambar orientalis resin 0.1 g, ground to powder and sealed in a non-woven bag inside a mesh pouch. The formula was developed through a three-round Delphi expert consensus process.
Placebo: sachet of identical appearance and weight containing whole-wheat flour, lily, chrysanthemum and orange-peel powder.
Procedure: both sachets were hung at the head of the bed within 30 cm of the nose from about 23:00 to 07:00 nightly for 9 weeks and replaced every 3 weeks; adherence was supported by a daily calendar record and nightly WeChat reminders. Both groups received the same health education on primary dysmenorrhea.
Sample size: based on a previously reported VAS effect (effect size 0.88, alpha 0.025 two-sided, power 0.90), 68 participants were required, increased by 20% for attrition to 82.
Analysis: within- and between-group comparisons using t-tests or Mann-Whitney/Wilcoxon tests as appropriate.
Safety: participants inhaled the sachet for 5 minutes and were observed for 10 minutes when it was first issued; adverse reactions were monitored throughout.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Traditional Chinese herbal sachet (aromatic inhalation), Placebo sachets
- Keywords
- primary dysmenorrhea, menstrual pain ·, traditional Chinese medicine, herbal sachet, aromatherapy, inhalation, college students
- Medical subject headings
- Dysmenorrhea, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo sachetsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo sachets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
17 menstrual symptoms each rated for severity and duration on 0-4 scales; total score range 0-136, higher scores indicate greater symptom burden.
Measured: Baseline and within 1 week after the end of the 9-week intervention
Change from baseline in Cox Menstrual Symptom Scale (CMSS) severity subscore
Sum of severity ratings for 17 symptoms; range 0-68, higher scores indicate more severe symptoms.
Measured: Baseline and within 1 week after the end of the 9-week intervention
Change from baseline in Cox Menstrual Symptom Scale (CMSS) duration subscore
Sum of duration ratings for 17 symptoms; range 0-68, higher scores indicate longer-lasting symptoms.
Measured: 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
20-item self-report scale; standard score range 25-100, with 50 or above indicating anxiety; higher scores mean more anxiety.
Measured: 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
20-item self-report scale; standard score range 25-100, with 50 or above indicating depression; higher scores mean more depressive symptoms.
Measured: Baseline and within 1 week after the end of the 9-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Nov 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macao Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Nursing Vocational College
- Responsible party
- Principal investigator, Cindy Sin U Leong, Macao Polytechnic University
- Investigators
- Cindy Sin U LEONG, DHSc, RN, Principal investigator, Macao Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778849
- Sponsor's protocol ID
- FCSD/MSN-0079/2023
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant-level data contain identifiable student health information. De-identified data may be made available by the corresponding author on reasonable request, subject to institutional and ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Delphi-Derived Traditional Chinese Herbal Sachet on Pain, Menstrual Symptoms, Anxiety and Depression in Female College Students With Primary Dysmenorrhea: A Randomized, Single-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07778849
- Acronym / sponsor ID
- FCSD/MSN-0079/2023
- Conditions
- Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, menstrual pain ·, traditional Chinese medicine, herbal sachet, aromatherapy, inhalation, college students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Macao Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Sichuan Nursing Vocational College
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: single-centre, randomized, single-blind (participant), placebo-controlled, two-arm parallel-group trial.
Randomization: participants were numbered in order of recruitment and allocated 1:1 using a computer-generated random number table (SPSS).
Intervention: herbal sachet containing Angelica dahurica root 5 g, Syzygium aromaticum flower bud 5 g, Artemisia argyi leaf 5 g, Foeniculum vulgare fruit 5 g, Kaempferia galanga rhizome 5 g, Cinnamomum cassia bark 10 g, Angelica sinensis root 10 g, Ligusticum chuanxiong rhizome 10 g, Cyperus rotundus rhizome 10 g, Aucklandia lappa root 10 g, Rosa rugosa flower bud 15 g, Osmanthus fragrans flower 15 g and Liquidambar orientalis resin 0.1 g, ground to powder and sealed in a non-woven bag inside a mesh pouch. The formula was developed through a three-round Delphi expert consensus process.
Placebo: sachet of identical appearance and weight containing whole-wheat flour, lily, chrysanthemum and orange-peel powder.
Procedure: both sachets were hung at the head of the bed within 30 cm of the nose from about 23:00 to 07:00 nightly for 9 weeks and replaced every 3 weeks; adherence was supported by a daily calendar record and nightly WeChat reminders. Both groups received the same health education on primary dysmenorrhea.
Sample size: based on a previously reported VAS effect (effect size 0.88, alpha 0.025 two-sided, power 0.90), 68 participants were required, increased by 20% for attrition to 82.
Analysis: within- and between-group comparisons using t-tests or Mann-Whitney/Wilcoxon tests as appropriate.
Safety: participants inhaled the sachet for 5 minutes and were observed for 10 minutes when it was first issued; adverse reactions were monitored throughout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbal sachet | Experimental | Other: Traditional Chinese herbal sachet (aromatic inhalation)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. |
| Placebo sachet | Placebo comparator | Other: Placebo sachetsIdentical-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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese herbal sachet (aromatic inhalation)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. | Other | Herbal sachet |
| Placebo sachetsSachet 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. | Other | Placebo sachet |
Primary outcome
Change from baseline in menstrual pain intensity (Visual Analogue Scale, VAS)
Time frame: Baseline and within 1 week after the end of the 9-week intervention
Pain rated on a 0-10 cm visual analogue scale (0 = no pain, 10 = worst imaginable pain); higher scores mean worse pain.
5 secondary outcomes
Change from baseline in Cox Menstrual Symptom Scale (CMSS) total score
Time frame: Baseline and within 1 week after the end of the 9-week intervention
Change from baseline in Cox Menstrual Symptom Scale (CMSS) severity subscore
Time frame: Baseline and within 1 week after the end of the 9-week intervention
Change from baseline in Cox Menstrual Symptom Scale (CMSS) duration subscore
Time frame: 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
Time frame: 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
Time frame: Baseline and within 1 week after the end of the 9-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. Participant-level data contain identifiable student health information. De-identified data may be made available by the corresponding author on reasonable request, subject to institutional and ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Sin U LEONG, DHSc, RN principal investigator
Macao Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese herbal sachet (aromatic inhalation) in people with Primary Dysmenorrhea, run by Macao Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in menstrual pain intensity (Visual Analogue Scale, VAS) (time frame: Baseline and within 1 week after the end of the 9-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.