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A randomized, double blind, placebo-controlled, multicenter trial for Qi Xue Kang oral liquid in the treatment of patients with Qi deficiency and blood stasis syndrome of prolonged menstruation and oligooligarchy

A randomized, double blind, placebo-controlled, multicenter trial for Qi Xue Kang oral liquid in the treatment of patients with Qi deficiency and blood stasis syndrome of prolonged menstruation and oligooligarchy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016338
Enrollment
Unknown
Registered
2018-05-25
Start date
2018-06-30
Completion date
Unknown
Last updated
2018-05-28

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

Conditions

Prolonged menstruation and menopausal patients with Qi deficiency and blood stasis syndrome

Interventions

experimental group:Oral liquid Qi Xue Kang oral liquid
control group:Oral placebo

Sponsors

Beijing Chinese Medicine Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: The subjects must meet all the following criteria before entering the group. 1. aged 18-45 years old, female; 2. patients with Qi deficiency and blood stasis syndrome (prolonged menstrual period): Chinese medicine diagnosis and TCM syndrome diagnosis which conform to the prolonged menstruation, TCM syndrome differentiation belongs to Qi deficiency and blood stasis; Qi deficiency and blood stasis syndrome (menstrual oligarchy) patients: Chinese medicine diagnosis and TCM syndrome diagnosis conforming to oligarchy, TCM syndrome differentiation belongs to Qi deficiency and blood stasis; 3. patients with prolonged menstrual period: a patient with an extended period of Western medicine for abnormal uterine bleeding (abnormal uterine bleeding related to ovulation, abnormal uterine bleeding caused by local abnormal endometrium); patients with oligomenstruum: a patient with western medicine diagnosed as a patient with oligomenstruum in the patients with abnormal uterine bleeding; 4. voluntarily signed informed consent. Volunteers of childbearing age voluntarily perform effective contraception measures during the trial period. 5. To be willing to cooperate with the test scheme, and will be good compliance.

Exclusion criteria

Exclusion criteria: If the subjects meet any of the following criteria, they can not be enrolled: 1. known patients who are allergic to any test drugs and their adjuvants; 2. patients with anaphylaxis; 3. combined with severe cardiovascular, hepatic, renal and hematopoietic primary diseases. 4. diabetic patients; 5. alanine aminotransferase (ALT), aspartate aminotransferase (AST) was higher than the upper limit of normal value of 1.5 times, and serum creatinine (Cr) was higher than the upper limit of normal value (the range of normal values in the laboratory of reference center); 6. alcoholism and drug dependence; 7. those who are unable to cooperate, such as having neurological or psychiatric disorders, such as epilepsy or mental disorders, or unwilling to cooperate; For 8.3 months, use Chinese medicine or western medicine for treatment of prolonged menstruation and oligohydramnios. Other patients with treatment; 9. patients scheduled for major elective surgery during the study period; 10. pregnant, lactation, or planned gestation; Who participated in or participated in other clinical trials within 11.3 months; 12. the researchers considered other patients unsuitable for the trial; In addition, subjects with prolonged menstruation should not be eligible for any of the following criteria: 1. combined with adenomyosis and pituitary tumor; 2. with caesarean section diverticulum; 3. abnormal uterine bleeding and abnormal uterine bleeding caused by atypical hyperplasia. 4. uterine abnormal bleeding caused by myoma of uterus; 5. abnormal uterine bleeding caused by systemic coagulation related diseases. 6. iatrogenic abnormal uterine bleeding; 7. other unclassified uterine bleeding; 8. patients in need of thrombin use or in clinical trials; 9. Patients who had history of blood donation or blood loss within 2 months (> 400 ml).

Design outcomes

Primary

MeasureTime frame
Changes in the length of the menstrual period before and after treatment;The change value of the volume compared with the baseline after treatment;

Countries

China

Contacts

Public ContactXiuxiang Teng

Beijing Chinese Medicine Hospital affiliated to Capital Medical University

tengxx@126.com+86 13717987052

Outcome results

None listed

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