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

Research and Development of WPAPS Based on the Modern Technology of Traditional Chinese Medicine

Dysmenorrhea

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.

Warm Palace Analgesic Point Sticker

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

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.

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'.

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).

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.

Participants in the CG group will be provided control sticker containing flour.The acupoints for applying the sticker are the same with experimental group

Research and Development of WPAPS Based on the Modern Technology of Traditional Chinese Medicine

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