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Clinical study on the efficacy, safety and mechanism of Neiyifang granule and decoction in the treatment of dysmenorrhea in endometriosis

Clinical study on the efficacy, safety and mechanism of Neiyifang granule and decoction in the treatment of dysmenorrhea in endometriosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070047
Enrollment
Unknown
Registered
2023-03-31
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

endometriosis

Interventions

Neiyifang decoction group:Neiyifang decoction
equaldose group of Neiyifang granule:equal-dose Neiyifang granule
2/3 dose group of Neiyifang granule:2/3 dose Neiyifang granule

Sponsors

Foshan Fosun Chancheng Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the diagnostic criteria for endometriosis. (2) Patients who meet the diagnostic criteria of kidney deficiency and blood stasis. (3) VAS greater than 2cm during the screening period. (4) Patients aged between 18 and 50 with normal menstruation (21-35 days) without menopause. (5) Patients who have informed consent and are voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: (1) Patients with acute pelvic inflammatory disease, malignant tumor of reproductive organs or local malignant tumor. (2) Patients who have used hormone suppressive therapy or Chinese medicine for endometriosis and stopped taking drugs for less than 3 months. (3) Patients who are lactational, pregnant or have a fertility plan within 3 months. (4) Patients with diseases of the heart, liver, kidney and hematopoietic system, suffer from (chronic) diseases such as diabetes, tuberculosis, hypertension, cancer and so on, which are easy to make physical changes. (5) Patients with severe menstrual disorders. (6) Patients who are being in other trials. (7) Patients who are allergic to traditional Chinese medicine which is used in this study.

Design outcomes

Primary

MeasureTime frame
Visual Analog Scales;Cox menstrual symptom scale;

Secondary

MeasureTime frame
Self-Rating Anxiety Scale;Self-Rating Depression Scale;36-item Short-Form;hemorheology index;inflammatory response indicators;CA125;Gynecological b-ultrasound;Endometriosis Health Profile 30;TCM kidney deficiency and blood stasis syndrome scale;

Countries

China

Contacts

Public ContactSuzhen Wu

Foshan Fosun Chancheng Hospital

fswszm@163.com13809708102

Outcome results

None listed

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