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Efficacy and safety of compound Maodongqing enema and its granule in the treatment of sequelae of pelvic inflammatory disease: a randomized controlled study

Efficacy and safety of compound Maodongqing enema solution and its granule in the treatment of sequelae of pelvic inflammatory disease: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000607
Enrollment
Unknown
Registered
2024-10-25
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sequelae of pelvic inflammatory disease

Interventions

2:Low dose compound Maodongqing enema granules
3:Traditional compound Maodongqing enema granules solution
1:High dose compound Maodongqing enema granules

Sponsors

Guangdong Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (A) patients who met the diagnostic criteria for sequelae of pelvic inflammatory disease that is uterine tenderness and adnexal tenderness on gynecological examination (B) women aged 18-50 years with a sexual history; (C) lower abdominal pain/lumbosacral pain Visual Analog Scales (VAS) =4; (D) regular menstrual cycle (21-35 days); (E) persons who provide informed consent.

Exclusion criteria

Exclusion criteria: (A) women who are or plan to become pregnant or breastfeed within six months; (B) confirmed gynecological malignant tumors benign tumors (including uterine fibroids > 5cm in maximum diameter and submucosal fibroids); Trichomonas and mycotic vaginitis; Acute cervicitis; Endometriosis adenomyosis pelvic venous stasis tuberculous pelvic inflammatory disease and other related symptoms; (C) patients with serum CA125 and erythrocyte sedimentation rate higher than 1.1 times the upper limit of normal reference value; (D) Liver function index (ALT AST) exceeding 1.5 times the upper limit of the normal reference value renal function index Scr exceeding the upper limit of the normal reference value; (E) acute sequelae of pelvic inflammatory disease; (F) patients who have received related treatment and used drugs with similar functional indications within 14 days; (G) patients with serious primary diseases of cardiovascular hepatic renal and hematological systems or mental disorders; (H) persons with allergic constitution or allergic to known drug ingredients; (I) patients who are currently enrolled in or have enrolled in another clinical trial within 3 months before the study; (J) a suspected or real history of alcohol or drug abuse; (K) patients with TCM retention enema contraindications; (L) The investigator considered it inappropriate to conduct the clinical investigation.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scales;

Secondary

MeasureTime frame
Central Sensitization Inventory;Inflammatory factors (TNF-a IL-6 IL-8 CRP);The size and other changes of gynecological B-ultrasound lesions;TCM symptom grading quantitative score and local signs severity grading score;McCormack scale score;Comprehensive efficacy evaluation of TCM;

Countries

China

Contacts

Public ContactLiang Xuefang

Guangdong Hospital of Traditional Chinese Medicine

liangxuefang@gzucm.edu.cn13926082916

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026