A Multicenter, Randomized, Double-blind Clinical Study on Honghua Ruyi Wan in Treatment of Pelvic inflammatory disease sequelae caused by chronic pelvic pain (qi stagnation and blood stasis syndrome)

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-15006945
• Date of registration: 2015-08-20
• Prospective Registration: Yes
• Primary sponsor: Dongfang Hospital Affiliated to Beijing University of Traditional Chinese Medicine
• Public title: A Multicenter, Randomized, Double-blind Clinical Study on Honghua Ruyi Wan in Treatment of Pelvic inflammatory disease sequelae caused by chronic pelvic pain (qi stagnation and blood stasis syndrome)
• Scientific title: A randomized, double-blind, parallel-group, multicenter clinical study to evaluate the efficacy and safety of Honghua Ruyi Wan in treatment of Pelvic inflammatory disease sequelae caused by chronic pelvic pain (qi stagnation and blood stasis syndrome)
• Date of first enrolment: 2015-09-01
• Target sample size: treatment group:210;control group:70;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=11677
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Jin Zhe

• Name: Wang Tengyan
• Affiliation: Tibet Cheezheng Tibetan Medicine Co.Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 1. Accord with Sequelae of pelvic inflammatory disease diagnostic criteria, Chronic pelvic pain lasts for more than six months;
2. Conform to the TCM Syndrome Differentiation of qi stagnation and blood stasis syndrome;
3. Female ages between 20 to 50 years, married or sexual life history person;
4. The menstrual cycle was 28 to 35 days;
5. The degree of chronic pelvic pain (VAS) score >=40mm;
6. The Subjects informed consent, voluntary acceptance test, procedure to obtain informed consent in accordance with the provisions of GCP.
Exclusion criteria: 1. Pregnancy, or Planned pregnancy within half a year, or Lactation;
2. The examination was confirmed by gynecological tumor (The maximum diameter of uterine fibroids is more than 3cm, submucous myoma, ovarian cyst), trichomonas vaginitis, vulvovaginal candidiasis, acute cervicitis, pelvic inflammatory disease, endometriosis, adenomyosis, pelvic venous stasis syndrome, interstitial cystitis (IC) and related symptoms caused by other diseases;
3. Serum CA-125>=35U/ml or ESR> 25mm/h (Westergren method);
4. Combined with severe primary diseases such as cardiovascular, liver, kidney and blood system or psychopaths;
5. Received similar treatments and similar function drugs within two weeks;
6. Patients are participating in other clinical trials or using antibiotics for treatment within 1 months;
7. Allergic constitution or allergic to the trial drug or allergic to the ingredients;
8. The disabled patients (blind, deaf, mute, amentia, mental disorder, physical disability) prescribed by law;
9. The subjects who were not suitable for this clinical trial that were judged by the investigators;
10. Subjects were suspected or confirmed to a history of alcohol or drug abuse, or classified by the investigator as other diseases or conditions which may reduce the possibility of enrollment or complicate the recruiting, for example, working environment change frequently, unstable living environment, and other problem easiy lost to follow up the trial.

Age minimum: 20
Age maximum: 50
Gender: Female

Health Condition(s) or Problem(s) studied

Pelvic inflammatory disease sequelae caused by chronic pelvic pain

Intervention(s)

treatment group:Honghua Ruyi Wan;control group:placebo;

Primary Outcome(s)

Pain relief after treatment (after the treatment, Compared with baseline, the proportion of patients who's VAS score decreased more than 30%);

Secondary Outcome(s)

Curative effect of the disease;The efficacy of TCM Syndrome;Change of the score of each individual symptoms and local signs;Pain VAS score decreased in each visit;Change of the the masses’ size after the treatment;Change of pelvic blood flow index after treatment;Change of the dimensions of EQ-5D score and EQ-VAS score after treatment;

Source(s) of Monetary Support

Gannan foge Tibetan medicine Co.Ltd