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The Observation of Clinical Effectiveness to Cure Hyperprolactinemia caused by Antipsychotic drugs with Kuntai Capsule

The Observation of Clinical Effectiveness to Cure Hyperprolactinemia caused by Antipsychotic drugs with Kuntai Capsule

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPh-17011440
Enrollment
Unknown
Registered
2017-05-19
Start date
2017-06-30
Completion date
Unknown
Last updated
2017-05-22

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

Conditions

Hyperprolactinemia

Interventions

Experimental group:cured by Kuntai Capsule

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Patients who met the following inclusion criteria were eligible for the study: 1. Women aged 18 to 55 years; 2. a primary diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders,4th Revision, now in stable condition, and score of Positive and Negative Syndrome Scale(PANSS) less than 60; 3. patients of outpatient and inpatient department are taking olanzapine or risperidone antipsychotic medications, if take cold medications at the same time, take in this study only after drug withdrawal; 4. had one of the following situations after taking the medications, and specific criteria see below, including (1) breast pain, defined as breast swell, itch or nipple bulge pain; (2)menstrual, including pre-menstrual, delayed menorrhea, irregularly menstrual, menorrhagia and hypomenorrhea, menostaxis. Pre-menstrual defined as menstrual cycle was advanced for 7 days, and last 3 menstrual cycles. Delayed menorrhea defined as menstrual cycle was prolonged for 7 days, and last 3 menstrual cycles. Irregularly menstrual defined as menstrual cycle was advanced or prolonged for 7 days, and for 3 menstrual cycles. Menorrhagia defined as every time the total menstrual quantity more than 80 mL and hypomenorrhea defined as every time the total menstrual quantity less than 20 mL or 2 days. Menostaxis defined as normal cycle and menstrual period more than 7 days; (3) amenorrhea defined as the absence of menstruation for 3 menstrual cycles; (4)galactorrhea defined as starts to lactate during non-lactation. 5. Level of serum prolactin higher than 540 mIU/L; 6. All participants and their guardians gave voluntary, written, informed consent before entering the trial.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating; 2. taking the oral contraceptives for a long time; 3. have obvious physical and nervous system disease in such as heart, liver, kidney ; 4. a history of alcoholism and drug dependence; 5. a primary organic adenomas in the hypothalamus, pituitary gland 6. polycystic ovarian syndrome; 7. primary decreased ovarian reserve; 8. Endometriosis.

Design outcomes

Primary

MeasureTime frame
level of prolactin;Clinical symptoms (e.g., breast tenderness, menoxenia, amenorrhea, lactation, etc.);

Secondary

MeasureTime frame
PANSS;PSQI;

Countries

China

Contacts

Public ContactYuan Chengmei

Shanghai Mental Health Center

yuanchengmei@yeah.net+86 13818132592

Outcome results

None listed

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