NCT07917637Completed
Ashwagandha Added to Risperidone for Quality of Life and Inflammation in Schizophrenia
Effects of Adjunctive Ashwagandha Therapy on Clinical Symptoms, Quality of Life, and Serum TNF-α Levels in Patients With Schizophrenia Receiving Risperidone
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
Schizophrenia is a chronic mental health disorder that affects thinking, emotions, behavior, and quality of life. Although antipsychotic medications such as risperidone are commonly used to manage schizophrenia, some patients continue to experience psychiatric symptoms and reduced quality of life. Inflammation may also contribute to the development and severity of schizophrenia. Ashwagandha (Withania somnifera) is a medicinal plant with potential anti-inflammatory and neuroprotective properties. This study evaluated whether adding ashwagandha to standard risperidone treatment could improve quality of life, reduce psychiatric symptoms, and lower blood levels of tumor necrosis factor-alpha (TNF-alpha), a marker of inflammation, in patients with schizophrenia. This randomized, double-blind, placebo-controlled study included 60 male patients with schizophrenia aged 20 to 45 years. Participants were randomly assigned to receive either ashwagandha plus risperidone or placebo plus risperidone for eight weeks. Quality of life, psychiatric symptoms, and blood levels of TNF-alpha were assessed at the beginning of the study and after eight weeks of treatment. The study aimed to provide additional evidence regarding the potential benefits of ashwagandha as an adjunctive treatment for schizophrenia.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 31 Oct 2026
- Start date
- 13 Mar 2026
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Athitah Pratiwi
- Diseases
- Schizophrenia
- NCT number
- NCT07917637
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 13 Mar 2026 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of anti-inflammatory medications, antibiotics, or antioxidant supplements.
Other illness
- History of substance use within the preceding six months, except caffeine or nicotine.
Other
- Presence of organic medical comorbidities.
- Intellectual disability.
- Changes in antipsychotic treatment during the screening period.
Who the study is looking for
- Male patients aged 20-45 years.
- Diagnosed with schizophrenia according to the International Classification of Diseases, 10th Revision (ICD-10), and the Indonesian Classification and Diagnostic Guidelines for Mental Disorders III (PPDGJ-III).
- Duration of schizophrenia of five years or less since disease onset.
- Having passed the acute agitation phase, defined by a Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score below 15.
- Receiving risperidone at a dose of 4 mg/day.
- Able to read and write.
- Willing to participate and able to provide written informed consent.
Age in the registry: 20 years to 45 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi Selatan Coordinator of this site? Confirm its status | Makassar | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.