An interventional study of Warm Palace Analgesic Point Sticker in Dysmenorrhea, sponsored by Hong Kong Baptist University. Status unknown at 1 site in Hong Kong. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Hong Kong Baptist University · Not applicable, Interventional, and Treatment
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:
Participants will :
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.
402 studies on the registry are indexed under Dysmenorrhea; 94 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 336 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Hong Kong Baptist University is the lead sponsor of 84 studies on the registry; 23 are open to participants now.
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(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.
Exclusion Criteria:
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.
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.
Device: Warm Palace Analgesic Point Sticker
Participants in the CG group will be provided control sticker containing flour.The acupoints for applying the sticker are the same with experimental group
Device: Warm Palace Analgesic Point Sticker
The Warm Palace Analgesic Point Sticker is developed by Changchun University of Traditional Chinese Medicine
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.
Time frame: through study completion, an average of 3 months
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'.
Time frame: 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).
Time frame: through study completion, an average of 3 months
TCM Body Constitution Scale Questionnaire
We will use the questionnaire developed by Prof. Wang Qi, School of Traditional Chinese Medicine, BUCM, to diagnose body constitution of subjects. There are totally 60 questions describing symptom of 9 constitutions, and each symptom is scored via 1-5: a score of one denotes that the symptom is not noticeable; while a score of five denotes that the symptom is severely bothersome.A score higher than 40% means that the patient belongs to that constitution.
Time frame: baseline, pre-intervention
TCM Syndrome Type Questionnaire
We will use a 16-item questionnaire to differentiate the type of dysmenorrhea. 16 questions describe symptoms of 5 syndrome type of dysmenorrhea, and each symptom is scored via 0-4: a score of zero denotes that the symptom is not noticeable; while a score of four denotes that the symptom is severely bothersome.A score higher than 75% means that the patient belongs to that syndrome type.
Time frame: baseline, pre-intervention
Tongue Image Features
We will distinguish the color of tongue with a color board, which used for judgement of TCM body constitution and syndrome type of dysmenorrhea
Time frame: through study completion, an average of 3 months
Started Dec 2022 (actual). Primary completion is estimated for Oct 2023, 10 months after the start.
Of 177 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 15. This study's planned 10 months is above that.
Counting every sponsor, half of 187 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Hong Kong Baptist University