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Herbal Supplement

Milk Thistle for Body Dysmorphic Disorder

Q: To what ailments is Milk Thistle typically prescribed?

<p>Milk Thistle is regularly administered to treat <a href="https://www.withpower.com/clinical-trials/nash">NASH</a>, and can also provide relief from hepatitis, long-term <a href="https://www.withpower.com/clinical-trials/cirrhosis">cirrhosis</a> of the liver, and nonalcoholic fatty liver disease.</p>

Phase 2

Waitlist Available

Led By Jon E Grant, JD, MD, MPH

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 9 weeks

Awards & highlights

Study Summary

This trial will study the effects of milk thistle on 15 people, divided into two 4-week phases with a one-week break in between. One phase will have the participants taking milk thistle, and the other phase will have them taking a placebo. The trial will be double-blind, meaning neither the participants nor the researchers will know which group is taking the milk thistle until the trial is over.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)

Secondary outcome measures

Clinical Global Impression- Severity and Improvement (CGI)

Hamilton Anxiety Rating Scale (HAM-A)

Hamilton Depression Rating Scale (HAM-D)

+1 more

Side effects data

From 2020 Phase 2 trial • 22 Patients • NCT02473913

17%

Nausea

Insomnia

Bloating

Headaches

100%

80%

60%

40%

20%

Study treatment Arm

Milk Thistle

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Silymarin (Milk Thistle)Experimental Treatment1 Intervention

Each subject will have a 4 week treatment phase with milk thistle.

Group II: PlaceboPlacebo Group1 Intervention

4 week placebo phase before or after milk thistle phase depending on randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Milk Thistle

2015

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,001 Previous Clinical Trials

817,730 Total Patients Enrolled

Jon E Grant, JD, MD, MPHPrincipal InvestigatorUniversity of Chicago

7 Previous Clinical Trials

877 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity for this research endeavor?

"Affirmative, clinicaltrials.gov displays that this investigation is actively recruiting candidates. Initially advertised on October 1st 2016, the trial necessitates 15 participants to be recruited at one location."

Answered by AI

Is this particular trial the inaugural study of its type?

"Currently, two trials for milk thistle are ongoing in multiple cities and countries. The first experiment took place in 2009, sponsored by Madaus Inc., with 140 participants making it through Phase 2 & 3 of the drug approval process. Since then, 18337 studies have been conducted."

Answered by AI

Who can participate in this clinical trial?

"Only those with body dysmorphic disorder and aged between 18-65 are eligible to participate in this research. 15 individuals need to be enrolled into the study."

Answered by AI

Does this trial currently have open enrollment?

"Per the information on clinicaltrials.gov, this trial is proactively seeking volunteers. The original posting was made on October 1st 2016 and the entry has since been updated November 2nd 2022."

Answered by AI

To what ailments is Milk Thistle typically prescribed?

"Milk Thistle is regularly administered to treat NASH, and can also provide relief from hepatitis, long-term cirrhosis of the liver, and nonalcoholic fatty liver disease."

Answered by AI

Has the FDA sanctioned Milk Thistle for medical use?

"Milk thistle has only been through two rounds of clinical testing, suggesting that the safety level is approximately a 2. Unfortunately, there is not yet any evidence to indicate its efficacy."

Answered by AI