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Clinical Research and Intelligent Platform Construction of Qingfu Chaijin Granules in Treating Dysmenorrhea of Qi Stagnation and Blood Stasis Type Uterine Adenomyosis

Clinical Research and Intelligent Platform Construction of Qingfu Chaijin Granules in Treating Dysmenorrhea of Qi Stagnation and Blood Stasis Type Uterine Adenomyosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000455
Enrollment
Unknown
Registered
2024-09-19
Start date
2024-07-08
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

adenomyosis

Interventions

placebo group:Qingfu Chaijin Granules Simulant is orally administered, with the same specifications, appearance, and packaging as Qingfu Chaijin Granules. Take it half an hour after breakfast and dinn
High dose group:High dose Qingfu Chaijin granules taken with boiling water half an hour after meals in the morning and evening 1 bag each time twice a day for a course of 3 months without stopping dur
Low dose group:Low dose Qingfu Chaijin granules, taken with boiling water half an hour after meals in the morning and evening, 1 bag each time, twice a day, for a course of 3 months without stopping d

Sponsors

Wangjing Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Meets the Western diagnostic criteria for adenomyosis; (2) Meets the traditional Chinese medicine differentiation criteria for qi stagnation and blood stasis syndrome; (3) Individuals aged between 18-50 with regular menstrual cycles (21-35 days); (4) Visual Analog Scale (VAS) score for dysmenorrhea symptoms = 4 points; (5) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with undiagnosed abnormal uterine bleeding or endometrial lesions acute pelvic inflammatory disease intrauterine adhesions and pelvic tuberculosis; (2) Patients who have received the same traditional Chinese medicine treatment in the past month; (3) The average diameter of the uterus is greater than 10.0cm; (4) Hemoglobin concentration<90g/dL; (5) Blood creatinine exceeds the upper limit of normal value or any one of ALT and AST exceeds 1.5 times the upper limit of normal value; (6) Pregnant or lactating women who are preparing for pregnancy within six months; (7) Patients with serious primary diseases such as heart cerebrovascular liver kidney and hematopoietic system diabetes thyroid disease and psychosis; (8) Individuals with allergic constitution and those who are allergic to the relevant ingredients of this medicine; (9) Participated in other clinical studies within the past month; (10) Individuals who require frequent use of painkillers due to other underlying illnesses; (11) Suspecting or confirming a history of alcohol addiction or drug abuse or other lesions or conditions that based on the researcher's judgment reduce the likelihood of inclusion or complicate inclusion such as frequent changes in work environment unstable living environment etc. which can easily lead to loss of follow-up; (12) Researchers believe that participants are not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale;the Cox Menstrual Symptom Scale;

Secondary

MeasureTime frame
Hemoglobin levels;Menstrual volume score;Serum CA125 levels; Serum CA199 level;Usage of Ibuprofen;Quality of Life Score;Traditional Chinese Medicine Syndrome Score;Uterine volume size and lesion size of localized adenomyosis;

Countries

China

Contacts

Public ContactWang Hao

Wangjing Hospital China Academy of Chinese Medical Sciences

pgwanghao@126.com+86 135 8157 7090

Outcome results

None listed

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