Clinical trial NCT05815654: Research and Development of WPAPS Based on the Modern Technology of Traditional Chinese Medicine
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Innovation and Technology Commission, Hong Kong
First posted: 2023-04-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 200 participants will be divided into experimental group and control group.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

(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.

Primary outcomes:
measure: Change From Baseline in Scores on the Cox Menstrual Symptom Scale at 3 Months
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: through study completion, an average of 3 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: through study completion, an average of 3 months
Other outcomes:
measure: TCM Body Constitution Scale Questionnaire
timeFrame: baseline, pre-intervention
measure: TCM Syndrome Type Questionnaire
timeFrame: baseline, pre-intervention
measure: Tongue Image Features
timeFrame: through study completion, an average of 3 months
Locations:
city: Kowloon Tong
country: Hong Kong
facility: School of Chinese Medicine Building
state: Kowloon
Study officials:
affiliation: Hong Kong Baptist University
name: Shi Ping Zhang
role: PRINCIPAL_INVESTIGATOR
References: