Randomized controlled study of modified Qingre Lishi Decoction and antibiotics in the treatment of chronic endometritis

Phase 1

• Conditions: Chronic Endometritis

• Registration Number: ITMCTR2200005503
• Lead Sponsor: Fuxing Hospital, Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

(1) Age: women of childbearing age, 18-40 years.
(2) Diagnosis of CE by endometrial histopathological CD138 immunohistochemical testing; diagnostic criteria: =1 CD138-positive cells/10 HPF.
(3) TCM syndrome type of Qi deficiency, dampness and heat.
(4) Voluntarily signed written informed consent.
(5) Histopathological diagnosis not suggestive of endometrial hyperplasia and endometrial cancer.
(6) willing to undergo repeat hysteroscopy and endometrial histopathological examination to evaluate CE regression.

Exclusion Criteria

(1) Received estrogen or progestin treatment within 1 month.
(2) Received Chinese herbal medicine and antibiotics within 1 month.
(3) History of allergy to Chinese herbal ingredients and antibiotics in addition to Qinghelian Dampness Soup.
(4) other medical indications requiring antibiotic treatment before re-hysteroscopy and histopathological examination of the endometrium.
(5) Cases requiring estrogen and progestin due to medical condition.
(6) Pregnancy status and pregnancy-related diseases.
(7) No randomized grouping was accepted.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endometrial CD138 Negative conversion rate;

Secondary Outcome Measures

Name	Time	Method
Hysteroscopy microscopic features;Endometrial CD56;