Berberine
DrugBerberine 300mg(three times a day) plus any atypical antipsychotic drug
NCT Number: NCT03548155
The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300 mg,three times a day), as an adjuvant therapy has been used on the basis of the Second-generation antipsychotics(SGAs) monotherapy. All participants were randomly divided into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile, inflammatory factors,adiponectin,leptin were obtained at 0, 4,8 weeks.
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Notify Me18 year–62 year
All sexes
Interventional
Not applicable
Glucose and lipid profile:Fasting blood samples for Fasting blood glucose(FBG),Insulin, Hemoglobin A1c(HbA1c), Total cholesterol(TC), Low-density lipoprotein cholesterol(LDL-C),High-density lipoprotein cholesterol(HDL-C), Triglycerides (TG),Apolipoprotein A(ApoA),Apolipoprotein B(ApoB),Lipoprotein-a(Lp-a) .
Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6 (IL-6), Tumor necrosis factor-α (TNF-α).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Berberine 300mg(three times a day) plus any atypical antipsychotic drug
Any atypical antipsychotic drug as the basic treatment
The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles
Time frame: changes within 0,4,8weeks
Positive and Negative Syndrome Scale(PANSS)has been used to assess symptom severity in schizophrenia.Of the items included in PANSS ,seven constitute a Positive scale,seven form a Negative scale and sixteen constitute a General Psychopathology scale.7-point rating instrument was conceived.A total Score is computed three subscales.Minimum scores is 30 and maximum scores is 210.The higher score are considered the psychiatric symptoms more serious.
Time frame: changes within 0,4,8 weeks
The levels of FBG has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8 weeks
The levels of Insulin has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8 weeks
The levels of TC has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8weeks
The levels of TG has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8weeks
The levels of HDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8weeks
The levels of LDL-C has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8weeks
Evaluate the safety of berberine
Time frame: changes within 0,4,8weeks
The levels of CRP has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8weeks
The levels of IL-1β has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8weeks
The levels of IL-6 has been obtained at 3 point intervals: 0, 4, 8 weeks
Time frame: changes within 0,4,8weeks
The levels of TNF-α has been obtained at 3 point intervals: 0, 4, 8 weeks
Tianjin Anding Hospital
Other
Berberine Effects on Clinical Symptoms and Metabolic Disturbance as an Adjunctive Therapy in Patients With Schizophrenia: a Randomized Double-blind Placebo-controlled Study
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