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

NCT05815654 | Unknown

• 1 other identifier: MHX/004/20
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 3 months

Secondary Outcomes (2)

• Numerical Rating Scale (NRS)

  through study completion, an average of 3 months

• Beck Anxiety Inventory (BAI)

  through study completion, an average of 3 months

Other Outcomes (3)

• TCM Body Constitution Scale Questionnaire

  baseline, pre-intervention

• TCM Syndrome Type Questionnaire

  baseline, pre-intervention

• Tongue Image Features

  through study completion, an average of 3 months

Study Arms (2)

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.

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

Device: Warm Palace Analgesic Point Sticker

Interventions

Warm Palace Analgesic Point Sticker DEVICE

The Warm Palace Analgesic Point Sticker is developed by Changchun University of Traditional Chinese Medicine

Control Group; Warm Palace Analgesic Point Sticker Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Dysmenorrhea only occur to female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Innovation and Technology Commission, Hong Kong: collaborator

Study Sites (1)

School of Chinese Medicine Building

Kowloon Tong, Kowloon, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Shi Ping Zhang

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po Ching Au

CONTACT

68224897; ching2022@hkbu.edu.hk

Jing Ting Tian

CONTACT

54846560; ayatian@hkbu.eu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be randomly assigned to the experimental group (EG), or the placebo control group (CG) at a ratio of 5:5 stratified by recruitment site. Stratified block randomization will be used according to probability theory. An independent statistician will generate random sequences using R software version 4.2.1 (R Project for Statistical Computing, Vienna, Austria), in which the TCM syndrome type, duration, and the severity of dysmenorrhea will be used as indicators, after a patient's qualification is confirmed, a randomization number and its corresponding sticker will be provided to the assistant by the PI. Then the assistant will give the specific sticker to the subjects to ensure that both the assistant and the subjects will not know which type of sticker they get.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 200 participants will be divided into experimental group and control group.

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 18, 2023
• Study Start: December 20, 2022
• Primary Completion: October 31, 2023
• Study Completion: February 29, 2024
• Last Updated: April 18, 2023

Record last verified: 2022-10

Locations

HK (1)