Honghuaruyi Wan for Endometriosis Dysmenorrhea

NCT04942015 | Unknown Phase 4 DMC

• 1 other identifier: HHRYW2021-05
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endometriosis is a common gynecological disease. It is a gynecological disease caused by the growth and reproduction of the endometrium beyond the surface of the uterine tissue and organs, which causes recurrent abdominal pain, infertility and other main symptoms. The recurrence of endometriosis and the side effects of medication have troubled clinicians and patients for a long time and the search for new drugs is going on all the time. Honghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea. In this study, the therapeutic effects of Honghuaruyi Wan provided by Tibet Qizheng Tibetan Medicine Co.,Ltd on secondary dysmenorrhea in patients with endometriosis was evaluated clinically. A multi-center, randomized, double-blind, placebo-controlled clinical trial was designed to provide evidence-based medical evidence for Honghuaruyi Wan in the treatment of endometriosis dysmenorrhea. In the design of this trial, the therapeutic effects and safety of Honghuaruyi Wan in the treatment of dysmenorrhea secondary to endometriosis were evaluated with Honghuaruyi Wan in the treatment group and placebo in the control group.

Conditions

Endometriosis; Dysmenorrhea

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale/Score (VAS)

  Draw a horizontal line of 10 cm on the paper. One end of the horizontal line is 0, indicating no pain.The other end is 10, which means severe pain; The part between the two ends represents different levels of pain. A higher score means a worse outcome.

  Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)

• Endometriosis Health Profle-5（EHP-5）

  The core questionnaire contains 5 questions，every question has 5 answers：Never=0，Very few=1，Sometimes=2，Often=3，Always=4. The minimum and maximum values are between 0 to 20 and a higher value means a worse outcome.

  Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)

• The 5-level EQ-5D version（EQ-5D-5L）

  There are 6 questions in the scale，the first 5 questions has 5 answers：No=0， A little bit=1， Moderate=2， Serious=3 Very serious=4. The minimum and maximum values are between 0 to 20 and a higher value means a worse outcome. The 6th question is about the status of the day visited. The minimum and maximum scores are between 0 to 100 and a higher value means a better outcome.

  Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)

Secondary Outcomes (5)

• Visual Analogue Scale/Score (VAS) of the maximum non-menstrual pelvic pain

  Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)

• The number of ibuprofen sustained-release capsules (or other NSAIDs) used

  Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)

• Number of days off for staff/students due to dysmenorrhea

  Baseline through 6th consecutive menstrual cycle. (One cycle = 28±7days)

• The maximum diameter of the uterus

  Baseline, After treatment (3rd menstrual cycle). (One cycle = 28±7days)

• The maximum diameter of the cysts

  Baseline, After treatment (3rd menstrual cycle). (One cycle = 28±7days)

Study Arms (2)

Honghuaruyi Wan

EXPERIMENTAL

Honghuaruyi Wan will be used in this arm. Patients should start taking medicine with warm water on the first day of menstruation. For patients with VAS score \< 7 points, 1g / time, twice a day; for patients with VAS score ≥ 7 points and pain is hard to bear, 2g / time, twice a day. According to the above usage and dosage, take 3 menstrual cycles continuously, and observe 3 menstrual cycles after stopping the drug.

Drug: Honghuaruyi Wan

Placebo

PLACEBO COMPARATOR

Placebo of Honghuaruyi Wan will be used in this arm. Patients should start taking medicine with warm water on the first day of menstruation. For patients with VAS score \< 7 points, 1g / time, twice a day; for patients with VAS score ≥ 7 points and pain is hard to bear, 2g / time, twice a day. According to the above usage and dosage, take 3 menstrual cycles continuously, and observe 3 menstrual cycles after stopping the drug.

Drug: Placebo of Honghuaruyi Wan

Interventions

Honghuaruyi Wan DRUG

Honghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea.(Pill (15 pills/plate ×2 plates/box))

Honghuaruyi Wan

Placebo of Honghuaruyi Wan DRUG

Honghuaruyi Wan simulation agent. Made of starch,dextrin and edible pigment from Tibet Qizheng Tibetan Medicine Co.,Ltd. ( Pill (15 pills/plate ×2 plates/box))

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet the diagnostic criteria for endometriosis and have dysmenorrhea VAS score ≥4 points;
• Age 18 to 45;
• Regular menstrual cycle (28±7 days);
• Not pregnant at the time of seeing a doctor and no pregnancy plan during the medication, can insist on contraception;
• No pelvic nodules or adnexal masses, or pelvic nodules or adnexal masses ≤4cm;
• CA125 is normal or slightly elevated (below 200U/ml).
• Patients who voluntarily signed the informed consent and had conditional follow-up.

You may not qualify if:

• Patients who have known to have malignancies of reproductive organs or other malignancies;
• Suffering from serious diseases or mental diseases such as cardiovascular, cerebrovascular, liver, kidney or hematopoietic system;
• Uterine fibroids (≥3cm) and adenomyosis (uterine over 6 weeks of gestation, the reference value of uterine tridiameter at 6 weeks is 12cm, 7.5cm, 4.5cm);
• Those who received hormone drug therapy within 3 months before enrollment;
• lactating patients.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Related Publications (1)

• Han M, Liang XF, Gao J, Wang Y, Cao LX, Wang BJ, Wang Y, Zhuoma Z, Liu JP, Du HL. Honghua Ruyi Pill, a compound herbal medicine, improves endometriosis-related dysmenorrhea: A multicenter randomized, double-blind, placebo-controlled trial. J Integr Med. 2025 Dec 29:S2095-4964(25)00203-1. doi: 10.1016/j.joim.2025.12.011. Online ahead of print.

  PMID: 41529972 DERIVED

MeSH Terms

Conditions

Endometriosis; Dysmenorrhea

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mei Han

  Centre for Evidence-based Chinese Medicine, Beijing University of Chinese Medicne

  STUDY CHAIR

Central Study Contacts

Mei Han

CONTACT

+86 10 64287002; hanmeizoujin@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 28, 2021
• Study Start: June 21, 2021
• Primary Completion: May 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share