Schizophrenia
Conditions
Interventions
Trial group:Modified Peony and Licorice Granules, Oral administration, 1 bag, twice a day. Course of treatment: 8 weeks.
Placebo group:Chinese herbal placebo,Oral administration, 1 bag, twice a day. Course of treatment: 8 weeks.
Sponsors
Beijing Anding Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18-45 years old 2. Complies with ICD-10 diagnostic criteria for schizophrenia; 3. Have been treated with antipsychotic drugs for at least 3 months, and the dosage of antipsychotic drugs has remained unchanged in the past month. Currently, my condition is stable, and my baseline PANSS score is less than 70 points; 4. At least one clinical manifestation of hyperprolactinemia, including infrequent menstruation (periods longer than 35 days), amenorrhea (three cycles or more than six months), lactation, decreased libido, and sexual frigidity; 5. Serum prolactin level>24ng/ml; 6. Meets the diagnostic criteria for traditional Chinese medicine syndrome of liver and kidney deficiency. The diagnosis of liver and kidney insufficiency is as follows: main symptoms: low or sparse menstrual flow, soreness and weakness of the waist and knees. Secondary symptoms: tinnitus, indifferent sexual desire. Tongue and pulse: pale red tongue, thin white coating, and thin pulse. At least two main and secondary symptoms must be met before diagnosis (tongue and pulse are not included in the list). 7. Informed consent must be signed by the individual or legal guardian and they must be able to comply with the research protocol.
Exclusion criteria
Exclusion criteria: 1. Having unstable physical illnesses; 2. Has engaged in suicidal and aggressive behavior; 3. Has engaged in excessive drinking behavior in the past year; 4. Has engaged in drug abuse behavior in the past year; 5. Currently receiving treatment with traditional Chinese medicine and other natural therapies; 6. History of allergies to traditional Chinese medicine; 7. Pregnant/breastfeeding, or refusing contraception during the trial period. 8. Autogenous hyperprolactinemia (non drug-induced)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in serum prolactin and other sex hormone levels in participants;Scale assessments (including PANSS, BARS, SAS, AIMS, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in serum prolactin and other sex hormone levels in subjects; | — |
Countries
China
Contacts
Public ContactZhang Zhiyang
Beijing Anding Hospital,Capital Medical University
Outcome results
None listed