Status:
COMPLETED
Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for Schizophrenia
Lead Sponsor:
K.N. Roy Chengappa
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Withania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or to build resistance to stress or diseases in indigenous medical systems in India for centuries. Modern scie...
Detailed Description
The primary aim is to determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total) and stress scores(PSS total) in persons with schizophrenia? The s...
Eligibility Criteria
Inclusion
- Adult males or females (≥ 18 years, to 75 years)
- DSM IV TR diagnosis of schizophrenia or schizoaffective disorder (If officially instituted by study initiation: DSM V diagnoses will be used).
- Ability to provide informed written consent
- PANSS total score ≥ 60, positive symptom cluster, (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content with at least 2 items scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme
- Current symptom exacerbation ≥ 2 weeks, but ≤ 1 year
- Receiving anti-psychotic medications for ≥ 4 weeks
- For women of child bearing age, a negative pregnancy test at screening.
Exclusion
- Testing positive for illicit substances (marijuana or alcohol use will be assessed on a case by case basis, caffeine and nicotine are excepted)
- Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis
- Seriously unstable medical illnesses
- Pregnant or breast feeding women
- Known allergy or history of serious adverse event with WSE
- Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior)
- Currently receiving antibiotics, anti-viral, or anti-parasitic medications
- Currently receiving immunosuppressive medications (e.g. corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs).
- Currently receiving NSAIDs or Aspirin (\>81 mg/day) on a daily basis or PRN use \> 2x/week (in the last 4 weeks).
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2016
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01793935
Start Date
April 1 2013
End Date
July 7 2016
Last Update
January 3 2018
Active Locations (1)
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1
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213