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A multicenter, randomized, double-blind, placebo-controlled clinical trial of kunning oral solution for the prevention of postoperative intrauterine adhesions (hysteroscopic intrauterine adhesions separation)

A multicenter, randomized, double-blind, placebo-controlled clinical trial of kunning oral solution for the prevention of postoperative intrauterine adhesions (hysteroscopic intrauterine adhesions separation)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004358
Enrollment
Unknown
Registered
2021-01-31
Start date
2021-02-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Intrauterine adhesions

Interventions

experimental group: kunning oral solution
control group:placebo

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following criteria to be selected: (1) It meets the diagnostic criteria of western medicine for intrauterine adhesions, and it belongs to mild or moderate intrauterine adhesions; (2) In line with the TCM syndrome differentiation, the diagnostic criteria of qi stagnation and blood stasis syndrome; (3) Female patients >= 18 years old and <= 45 years old; (4) Intrauterine adhesions occurred after intrauterine surgery, and hysteroscopic intrauterine adhesions separation was needed; (5) Volunteer to participate in clinical trials and sign informed consent.

Exclusion criteria

Exclusion criteria: Subjects meeting one or more of the following criteria will be excluded: (1) Physiological amenorrhea, such as pregnancy or lactation, or less menstruation and amenorrhea caused by hyperprolactinemia, polycystic ovary syndrome, premature ovarian failure, pituitary disease or thyroid disease; (2) Those who plan to become pregnant within the last 3 months; (3) Patients with other endometrial diseases (such as fibroids, tuberculosis, uterine malformation, endometriosis, etc.) confirmed by hysteroscopy; (4) Patients with acute and subacute genital tract inflammation; (5) Complicated with other diseases, such as breast disease, thrombosis prone disease, lung disease, etc.; (6) Patients with severe hypertension, cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases; (7) ALT and AST of liver function exceed 1.5 times of the upper limit of reference value, or SCR of kidney function exceed the upper limit of reference value; (8) Patients who had undergone intrauterine adhesion separation; (9) Patients with mental or neurological diseases; (10) Patients with malignant tumor disease; (11) Patients treated with estrogen or progesterone one month before surgery; (12) People with allergic constitution, allergy or intolerance to known ingredients or any excipients of the drug studied; (13) Suspecting or having a history of alcohol and drug abuse; (14) Participating in or currently participating in other clinical trials within the last 3 months; (15) The researchers consider it inappropriate to conduct clinical trials.

Design outcomes

Primary

MeasureTime frame
Menstruation score;Markers of endometrial receptivity;TCM syndrome scoring;Endometrial thickness under ultrasound;Endometrium and subendometrium blood flow parameters under ultrasound;Endometrial typing;Hysteroscopic evaluation of uterine cavity morphology;

Countries

China

Contacts

Public ContactShi Wang
wangs@bcerd.com+86 13466582966

Outcome results

None listed

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