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A prospective, randomized, double-blind, multicenter clinical study of Neiyifang in the treatment of congealing cold blood stasis of endometriosis

A prospective, randomized, double-blind, multicenter clinical study of Neiyifang in the treatment of congealing cold blood stasis of endometriosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005646
Enrollment
Unknown
Registered
2022-02-18
Start date
2022-03-01
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

endometriosis

Interventions

Neiyifang formula granule + Drospirenone and Ethinylestradiol Tablets (?) placebo group:Neiyifang formula granule + Drospirenone and Ethinylestradiol Tablets (?) placebo
Drospirenone and Ethinylestradiol Tablets (?) +Neiyifang formula granule placebo group:Drospirenone and Ethinylestradiol Tablets (?) +Neiyifang formula granule placebo

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: ? All cases should meet EM clinical diagnostic criteria and TCM diagnostic criteria of congealing cold blood stasis syndrome; ? 18-40 years old; ? Menstrual cycle between 21 and 35 days, period of 3 to 7 days; (4) VAS score =3, and pain must be continuous or recurrent for at least 6 months; ? Those who voluntarily participated in the experiment and signed the informed consent; ? Those who have not been treated with Western medicine or have been treated with western medicine but have stopped taking medicine for 3 months.

Exclusion criteria

Exclusion criteria: 1) patients with adenomyosis; 2) Patients with serious diseases such as cardiovascular, cerebrovascular, liver, kidney, diabetes and tumor; 3) Mental illness and long-term alcohol or drug use affect cognition; 4) Patients with chronic pelvic pain caused by anxiety and depression (depression scale and anxiety scale =50 points). (Less than 50 on the SELF-rated Anxiety scale/Self-rated Depression scale was considered normal; A score of 50-60 was mild anxiety; A score of 61 to 70 indicates moderate anxiety, while a score of 70 or more indicates severe anxiety.) 5) Long-term use of painkillers or overuse of painkillers (more than 10 days in a month); 6) Suspected or confirmed history of smoking, alcohol and drug abuse; 7) Women who have positive pregnancy test, are pregnant or breast-feeding, or plan to have a pregnancy; 8) allergic constitution and known allergic to the composition of the drug; 9) Participants in other clinical trials or participants in clinical trials within 3 months prior to screening; 10) Patients with coagulation dysfunction and previous thrombotic diseases; 11) Those who are considered unsuitable for the clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
remission rate of EAPP;

Secondary

MeasureTime frame
CA125;TCM syndrome score;COX-Menstrual symptom score;VAS, DYS, NMPP of EAPP;EHP-5;

Countries

China

Contacts

Public ContactYu-Chaoqin

Naval Medical University

chqyu81@163.com13818390984

Outcome results

None listed

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