NCT05815654

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hong Kong Baptist University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DEVICE	Warm Palace Analgesic Point Sticker	The Warm Palace Analgesic Point Sticker is developed by Changchun University of Traditional Chinese Medicine

Timeline

• Start date: 2022-12-20
• Primary completion: 2023-10-31
• Completion: 2024-02-29
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: Hong Kong