NCT07917637
Ashwagandha Added to Risperidone for Quality of Life and Inflammation in Schizophrenia
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Change in Serum TNF-alpha Concentration From Baseline to Week 8
Timeframe: Baseline and Week 8
Secondary (7)
Change in Total SQLS-R4 Score From Baseline to Week 8
Change in Total BPRS Score From Baseline to Week 8
Change in SQLS-R4 Psychosocial Domain Score From Baseline to Week 8
Change in SQLS-R4 Cognition and Vitality Domain Score From Baseline to Week 8
Change in BPRS Affective Symptom Domain Score From Baseline to Week 8
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Change in BPRS Positive Symptom Domain Score From Baseline to Week 8
Change in BPRS Negative Symptom Domain Score From Baseline to Week 8
Arms and interventions
Ashwagandha Plus RisperidoneExperimental
Participants received risperidone 4 mg/day combined with standardized Withania somnifera (ashwagandha) extract 1,000 mg/day, administered orally in two divided doses of 500 mg for eight weeks. The ashwagandha extract contained 5% withanolides.
Placebo Plus RisperidonePlacebo comparator
Participants received risperidone 4 mg/day combined with matching placebo capsules administered orally for eight weeks. The placebo capsules were matched in appearance to the ashwagandha capsules.
Dietary supplements: Withania somnifera (Ashwagandha) Extract, Placebo capsules
Drugs: Risperidone 4mg/day
Sites
1 site in 1 country
- Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi SelatanMakassar, South Sulawesi, Indonesia