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Ashwagandha for Schizophrenia
Phase 2 & 3
Waitlist Available
Research Sponsored by Chengappa, K.N. Roy, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of a positive symptom exacerbation during the year prior to study entry.
Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or schizoaffective disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test whether a standardized extract of Withania somnifera can reduce psychopathology scores in people with schizophrenia.
Who is the study for?
This trial is for adults with schizophrenia or schizoaffective disorder, who have had a recent symptom exacerbation and score high on specific psychopathology scales. Women must not be pregnant or breastfeeding and should test negative for pregnancy. Participants must not be using certain drugs like immunosuppressants, undergoing addiction treatment (case by case), or have serious unstable illnesses.Check my eligibility
What is being tested?
The study tests if Withania somnifera extract (WSE) can lower psychopathology scores in people with schizophrenia compared to a placebo. It looks at the overall impact on mental health symptoms as well as stress levels measured by the Perceived Stress Scale.See study design
What are the potential side effects?
Potential side effects of WSE are not detailed here but may include allergic reactions based on past adverse events noted in individuals with known allergy to WSE. As it's an herbal supplement, other side effects could vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My symptoms have worsened in the past year.
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positive and Negative Symptom Scale
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Withania Somnifera Extract (WSE)Experimental Treatment1 Intervention
WSE 500 mg bid for 12 weeks
Group II: Placebo tabletsPlacebo Group1 Intervention
Placebo oral tablet bid for 12 weeks
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Who is running the clinical trial?
Chengappa, K.N. Roy, MDLead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Maryland Psychiatric Research CenterUNKNOWN
Stanley Medical Research InstituteOTHER
140 Previous Clinical Trials
10,342 Total Patients Enrolled
83 Trials studying Schizophrenia
6,280 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not tested positive for illicit drugs, except possibly for marijuana or opioids.My symptoms have worsened in the past year.I am currently on medication that suppresses my immune system.I am currently taking antibiotics, anti-viral, or anti-parasitic medications.You are pregnant or currently breastfeeding.You have severe and unstable medical conditions.I have been diagnosed with schizophrenia or schizoaffective disorder.You have behavior that makes it likely that you may need to be hospitalized soon, such as being suicidal or aggressive.I am on medication for addiction, which will need review.You have had a serious allergic reaction or bad experience with WSE in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo tablets
- Group 2: Withania Somnifera Extract (WSE)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical research program have an age limit?
"According to the age requirements set out in the inclusion criteria, the youngest eligible participants must be 18 years old while the oldest can be 64."
Answered by AI
Is this study currently looking for more participants?
"Yes, as of July 6th, 2022 this study is still seeking patients who meet the eligibility criteria. This research was first made public on December 1st, 2018."
Answered by AI
How do I sign up for the chance to participate in this research project?
"Individuals with a diagnosis of schizophrenia who are between 18-64 years old may be eligible for this study which is looking to enroll a total of 66 participants."
Answered by AI
How many subjects are taking lenalidomide in this experiment?
"That is correct. According to the information available on clinicaltrials.gov, this particular trial is still recruiting patients. The trial was first posted on December 1st, 2018 and was updated on July 6th, 2022. The trial is looking for 66 participants at 1 location."
Answered by AI
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