DysmenorrheaNCT05815654
Research and Development of WPAPS Based on the Modern Technology of Traditional Chinese Medicine
A study testing Warm Palace Analgesic Point Sticker in people with Dysmenorrhea, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial summary
The goal of this double-blind randomized controlled trial is to determine the efficacy of Warm Palace Analgesic Point Sticker in relieving dysmenorrhea compared to placebo sticker. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Warm Palace Analgesic Point Sticker
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Dec 2022to 29 Feb 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (1)18-35 years old; (2) Have a regular history of the menstrual cycle (28 days ± 7 days); (3) The first dysmenorrhea occurs before the age of 25, and at least 2 cycles after menarche; (4) No pregnancy/abortion / ectopic pregnancy history before the first dysmenorrhea; (5) Moderate to severe menstrual pain experienced at least 3 menstrual cycles prior to enrollment; (6) TCM syndrome differentiation is Qi stagnation and blood stasis syndrome and cold dampness syndrome.
Who cannot join
- Women with secondary dysmenorrhea (include but not limited to endometriosis, pelvic inflammation or hysteromyoma) confirmed by gynaecologists through B-mode ultrasound; (2) Women with irregular menstrual cycle (menstruation is advanced or delayed no more than 7 days); (3) women who are suffering from uncontrollable nervous system diseases, immune deficiency, haemorrhagic diseases or other serious chronic diseases; (4) women who have taken prostaglandin synthase inhibitor (PGSI) two weeks before enrolment; (5) women who are lactating, pregnant or planning to pregnant in the next 6 months; (6) women who are taking drugs that may affect the results of the study (include but not limited to NSAIDs and oral contraceptives); (7) Women who are receiving moxibustion or have received moxibustion 2 weeks before enrolment; (8) Women who are participating in other clinical studies; (9) Those who cannot cooperate with application treatment; (10) Have a history of severe skin allergy and are allergic to more than 2 kinds of food or drugs.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Chinese Medicine Building
Kowloon Tong, Kowloon, 0000
Po Ching Au, Bachelor, 8526822 4897, ching2022@hkbu.edu.hk
Shi Ping Zhang, PhD, 85234112466 ext. 2466, spzhang@hkbu.edu.hk
About this study
Official title: Research and Development of Warm Palace Analgesic Point Stickers Based on the Modern Technology of Traditional Chinese Medicine: Study Protocol for a Randomized Controlled Trial
The goal of this double-blind randomized controlled trial is to determine the efficacy of Warm Palace Analgesic Point Sticker in relieving dysmenorrhea compared to placebo sticker. The main questions it aims to answer are:
- Can this Warm Palace Analgesic Point Sticker relieve dysmenorrhea?
- It is more effective to certain type of TCM syndrome differentiation? Qi stagnation and blood stasis syndrome or cold dampness syndrome?
Participants will :
- receive test sticker or control sticker five days before every menstruation, once a day, five hours each time, for five consecutive days
- take pictures of tongue
- fill in some questionnaires after treatment
Read the detailed description
This study aims to determine the efficacy of Warm Palace Analgesic Point Sticker in relieving dysmenorrhea compared to placebo sticker through a double-blind, randomized controlled trial.
Two hundred participants will be enrolled. This trial consisting of an intervention phase for three menstrual cycles. After receiving an explanation of the trial and providing online informed consent, participants will be given screening numbers by registration order. Pain intensity of participants who completed the screening test will be assessed as baseline information during a run-in period. The run-in period will not exceed 40days. Before the run-in period, the participants will be offered an online diary and educated on how to record pain intensity using the Numerical Rating Scale (NRS) from one day before menstruation starts until menstruation ends. The participants will be forbidden to self-administer the medications presented in the exclusion or drop-out criteria. Participants with moderate or severe level of pain, average NRS pain scores greater than 4 on the first and second days of menstruation will be selected for enrollment in this trial, and the selected participants will receive randomly generated enrollment numbers. After the screening, the subjects will attend an online interview for evaluation, briefing, and tongue photo capturing and photo taking training. Then subjects will be randomly divided into two groups, the test sticker group, and the control sticker group. The total study period for each subject will be three months. Within three days from the end of the previous menstruation cycle, the participants will contact the research assistant, return their online diary, answer questionnaires regarding outcome measurements, and send back their tongue picture at each assessment. The intervention will be done during three menstrual cycles. One menstrual cycle may range from 21 to 40 days. We plan to conduct this trial for two years, starting from November 2022.
- Conditions
- Dysmenorrhea
- Being tested
- Warm Palace Analgesic Point Sticker
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Palace Analgesic Point StickerDevice
The Warm Palace Analgesic Point Sticker is developed by Changchun University of Traditional Chinese Medicine
| Study group | Role | What they receive |
|---|---|---|
| Warm Palace Analgesic Point Sticker Group | Experimental | Participants in the EG group will be provided test sticker, containing Ding Xiang, Rou Gui, Gan Jiang, Huang Jie Zi, Rou Cong Rong, Xiao Hui Xiang, Hua Jiao, Ai Ye, Xiang Fu, Wu Zhu Yu, Graphene（0.01%）The acupoints for applying the sticker are Guanyuan (CV4), Zigong (EX-CA1), and Sanyinjiao (SP6). The subjects will be reminded to closely observe their skin during the process and remove the sticker in time if the subjects feel itchy or painful, and record the adverse event. Receives: Device: Warm Palace Analgesic Point Sticker |
| Control Group | Placebo comparator | Participants in the CG group will be provided control sticker containing flour.The acupoints for applying the sticker are the same with experimental group Receives: Device: Warm Palace Analgesic Point Sticker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Scores on the Cox Menstrual Symptom Scale at 3 Months
This scale was developed by the University of Virginia to evaluate the severity and duration of dysmenorrhea symptoms. The scale includes 17 items, all of which adopt the 5-level scoring method, in which 0 is for not noticeable / did not occur, 1 is for slightly bothersome / lasted less than 3 hours, 2 is for moderate bothersome/lasting 3-7 hours, 3 is for severely bothersome / lasted 7-24 hours, and 4 is for very severely bothersome / lasted > 24 hours. The severity and duration of symptoms are scored separately, which can not only analyse the overall state but also study the state of each item. The higher the score, the more serious the condition is.
Measured: through study completion, an average of 3 months
Secondary outcomes (2)
Numerical Rating Scale (NRS)
In a Numerical Rating Scale (NRS), patients are asked to select the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: through study completion, an average of 3 months
Beck Anxiety Inventory (BAI)
BAI measures anxiety severity through a self-statement manner. This scale contains 21 items with a four-point scoring method describing anxiety symptoms. On the scale, 0 is for "Not at All", 1 is for "Mildly but it did not bother me much", 2 is for "Moderately -it was not pleasant at times", and 3 is for "Severely - it bothered me a lot", to measure and infer the anxiety severity. Scores may range from 0 to 63 with 4 levels: minimal anxiety (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Dec 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- 200 participants will be divided into experimental group and control group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Shi Ping Zhang, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815654
- Sponsor's protocol ID
- MHX/004/20
- Status last verified
- Oct 2022
- First submitted
- 20 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Development of Warm Palace Analgesic Point Stickers Based on the Modern Technology of Traditional Chinese Medicine: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05815654
- Acronym / sponsor ID
- MHX/004/20
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Innovation and Technology Commission, Hong Kong
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 18 Apr 2023 (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.
The goal of this double-blind randomized controlled trial is to determine the efficacy of Warm Palace Analgesic Point Sticker in relieving dysmenorrhea compared to placebo sticker. The main questions it aims to answer are:
- Can this Warm Palace Analgesic Point Sticker relieve dysmenorrhea?
- It is more effective to certain type of TCM syndrome differentiation? Qi stagnation and blood stasis syndrome or cold dampness syndrome?
Participants will :
- receive test sticker or control sticker five days before every menstruation, once a day, five hours each time, for five consecutive days
- take pictures of tongue
- fill in some questionnaires after treatment
Detailed description
This study aims to determine the efficacy of Warm Palace Analgesic Point Sticker in relieving dysmenorrhea compared to placebo sticker through a double-blind, randomized controlled trial.
Two hundred participants will be enrolled. This trial consisting of an intervention phase for three menstrual cycles. After receiving an explanation of the trial and providing online informed consent, participants will be given screening numbers by registration order. Pain intensity of participants who completed the screening test will be assessed as baseline information during a run-in period. The run-in period will not exceed 40days. Before the run-in period, the participants will be offered an online diary and educated on how to record pain intensity using the Numerical Rating Scale (NRS) from one day before menstruation starts until menstruation ends. The participants will be forbidden to self-administer the medications presented in the exclusion or drop-out criteria. Participants with moderate or severe level of pain, average NRS pain scores greater than 4 on the first and second days of menstruation will be selected for enrollment in this trial, and the selected participants will receive randomly generated enrollment numbers. After the screening, the subjects will attend an online interview for evaluation, briefing, and tongue photo capturing and photo taking training. Then subjects will be randomly divided into two groups, the test sticker group, and the control sticker group. The total study period for each subject will be three months. Within three days from the end of the previous menstruation cycle, the participants will contact the research assistant, return their online diary, answer questionnaires regarding outcome measurements, and send back their tongue picture at each assessment. The intervention will be done during three menstrual cycles. One menstrual cycle may range from 21 to 40 days. We plan to conduct this trial for two years, starting from November 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 200 participants will be divided into experimental group and control group.
| Arm | Type | Receives |
|---|---|---|
| Warm Palace Analgesic Point Sticker Group | Experimental | Device: Warm Palace Analgesic Point StickerParticipants in the EG group will be provided test sticker, containing Ding Xiang, Rou Gui, Gan Jiang, Huang Jie Zi, Rou Cong Rong, Xiao Hui Xiang, Hua Jiao, Ai Ye, Xiang Fu, Wu Zhu Yu, Graphene（0.01%）The acupoints for applying the sticker are Guanyuan (CV4), Zigong (EX-CA1), and Sanyinjiao (SP6). The subjects will be reminded to closely observe their skin during the process and remove the sticker in time if the subjects feel itchy or painful, and record the adverse event. |
| Control Group | Placebo comparator | Device: Warm Palace Analgesic Point StickerParticipants in the CG group will be provided control sticker containing flour.The acupoints for applying the sticker are the same with experimental group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1)18-35 years old; (2) Have a regular history of the menstrual cycle (28 days ± 7 days); (3) The first dysmenorrhea occurs before the age of 25, and at least 2 cycles after menarche; (4) No pregnancy/abortion / ectopic pregnancy history before the first dysmenorrhea; (5) Moderate to severe menstrual pain experienced at least 3 menstrual cycles prior to enrollment; (6) TCM syndrome differentiation is Qi stagnation and blood stasis syndrome and cold dampness syndrome.
Key exclusion criteria (1 listed)
- Women with secondary dysmenorrhea (include but not limited to endometriosis, pelvic inflammation or hysteromyoma) confirmed by gynaecologists through B-mode ultrasound; (2) Women with irregular menstrual cycle (menstruation is advanced or delayed no more than 7 days); (3) women who are suffering from uncontrollable nervous system diseases, immune deficiency, haemorrhagic diseases or other serious chronic diseases; (4) women who have taken prostaglandin synthase inhibitor (PGSI) two weeks before enrolment; (5) women who are lactating, pregnant or planning to pregnant in the next 6 months; (6) women who are taking drugs that may affect the results of the study (include but not limited to NSAIDs and oral contraceptives); (7) Women who are receiving moxibustion or have received moxibustion 2 weeks before enrolment; (8) Women who are participating in other clinical studies; (9) Those who cannot cooperate with application treatment; (10) Have a history of severe skin allergy and are allergic to more than 2 kinds of food or drugs.
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 |
|---|---|---|
| Warm Palace Analgesic Point StickerThe Warm Palace Analgesic Point Sticker is developed by Changchun University of Traditional Chinese Medicine | Device | Control Group, Warm Palace Analgesic Point Sticker Group |
Primary outcome
Change From Baseline in Scores on the Cox Menstrual Symptom Scale at 3 Months
Time frame: through study completion, an average of 3 months
This scale was developed by the University of Virginia to evaluate the severity and duration of dysmenorrhea symptoms. The scale includes 17 items, all of which adopt the 5-level scoring method, in which 0 is for not noticeable / did not occur, 1 is for slightly bothersome / lasted less than 3 hours, 2 is for moderate bothersome/lasting 3-7 hours, 3 is for severely bothersome / lasted 7-24 hours, and 4 is for very severely bothersome / lasted > 24 hours. The severity and duration of symptoms are scored separately, which can not only analyse the overall state but also study the state of each item. The higher the score, the more serious the condition is.
2 secondary outcomes
Numerical Rating Scale (NRS)
Time frame: through study completion, an average of 3 months
Beck Anxiety Inventory (BAI)
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
Shi Ping Zhang principal investigator
Hong Kong Baptist 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 Warm Palace Analgesic Point Sticker in people with Dysmenorrhea, run by Hong Kong Baptist University at 1 site in Hong Kong.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po Ching Au (68224897, ching2022@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Scores on the Cox Menstrual Symptom Scale at 3 Months (time frame: through study completion, an average of 3 months). 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 18 Apr 2023.