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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Baseline and 9 weeks
Trial Safety
Safety Progress
Side Effects for
Trial Design
2 Treatment Groups
Silymarin (Milk Thistle)
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
2 Treatment Groups
Primary Treatment: Milk Thistle · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
- “Body Dysmorphic Disorder: 30 Cases of Imagined Ugliness”. 1993. “Body Dysmorphic Disorder: 30 Cases of Imagined Ugliness”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/ajp.150.2.302.
- Dunai, J., I. Labuschagne, D. J. Castle, M. Kyrios, and S. L. Rossell. 2009. “Executive Function in Body Dysmorphic Disorder”. Psychological Medicine. Cambridge University Press (CUP). doi:10.1017/s003329170999198x.
- Jain, Nishant S., Uday Kannamwar, and Lokesh Verma. 2016. “Ethanol Induced Antidepressant-like Effect in the Mouse Forced Swimming Test: Modulation by Serotonergic System”. Psychopharmacology. Springer Science and Business Media LLC. doi:10.1007/s00213-016-4478-4.
- Seamans, Jeremy K., and Charles R. Yang. 2004. “The Principal Features and Mechanisms of Dopamine Modulation in the Prefrontal Cortex”. Progress in Neurobiology. Elsevier BV. doi:10.1016/j.pneurobio.2004.05.006.
- HAMILTON, MAX. 1959. “The Assessment of Anxiety States by Rating”. British Journal of Medical Psychology. Wiley. doi:10.1111/j.2044-8341.1959.tb00467.x.
- Phillips, Katharine A., Ralph S. Albertini, and Steven A. Rasmussen. 2002. “A Randomized Placebo-controlled Trial of Fluoxetine in Body Dysmorphic Disorder”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archpsyc.59.4.381.
- Lu, Ping, Takayoshi Mamiya, Lingling Lu, Akihiro Mouri, Minae Niwa, Hyoung-Chun Kim, Li-Bo Zou, et al.. 2010. “Silibinin Attenuates Cognitive Deficits and Decreases of Dopamine and Serotonin Induced by Repeated Methamphetamine Treatment”. Behavioural Brain Research. Elsevier BV. doi:10.1016/j.bbr.2009.10.024.
- Buchanan, B. G., S. L. Rossell, J. J. Maller, W. L. Toh, S. Brennan, and D. J. Castle. 2013. “Brain Connectivity in Body Dysmorphic Disorder Compared with Controls: A Diffusion Tensor Imaging Study”. Psychological Medicine. Cambridge University Press (CUP). doi:10.1017/s0033291713000421.
- Phillips, Katharine A.. 2002. “Pharmacologic Treatment of Body Dysmorphic Disorder: Review of the Evidence and a Recommended Treatment Approach”. CNS Spectrums. Cambridge University Press (CUP). doi:10.1017/s109285290001796x.
- Rosario-Campos, M C, E C Miguel, S Quatrano, P Chacon, Y Ferrao, D Findley, L Katsovich, et al.. 2006. “The Dimensional Yale–brown Obsessive–compulsive Scale (DY-BOCS): An Instrument for Assessing Obsessive–compulsive Symptom Dimensions”. Molecular Psychiatry. Springer Science and Business Media LLC. doi:10.1038/sj.mp.4001798.
- Burker, Eileen J., Donna M. Evon, Marci Marroquin Losielle, Jerry B. Finkel, and Michael R. Mill. 2005. “Coping Predicts Depression and Disability in Heart Transplant Candidates”. Journal of Psychosomatic Research. Elsevier BV. doi:10.1016/j.jpsychores.2005.06.055.
- Massoubre, C., H. Bonnefond, A. Grosselin, A. Nelva, J. Pellet, and F. Lang. 2009. “Étude préliminaire comparative de l’instrument d’évaluation des troubles de la personnalité DIP avec l’entretien semi-structuré SCID-II”. L'encéphale. Elsevier BV. doi:10.1016/j.encep.2008.09.007.
- Seamans JK, Yang CR. The principal features and mechanisms of dopamine modulation in the prefrontal cortex. Prog Neurobiol. 2004 Sep;74(1):1-58. doi: 10.1016/j.pneurobio.2004.05.006. Erratum In: Prog Neurobiol. 2004 Dec;74(5):321.
- HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
- Phillips KA. Pharmacologic treatment of body dysmorphic disorder: review of the evidence and a recommended treatment approach. CNS Spectr. 2002 Jun;7(6):453-60, 463. doi: 10.1017/s109285290001796x.
- Burker EJ, Evon DM, Marroquin Loiselle M, Finkel JB, Mill MR. Coping predicts depression and disability in heart transplant candidates. J Psychosom Res. 2005 Oct;59(4):215-22. doi: 10.1016/j.jpsychores.2005.06.055. Erratum In: J Psychosom Res. 2006 Jul;61(1):137. Marroquin Losielle, Marci [corrected to Marroquin Loiselle, Marci]. J Psychosom Res. 2006 Mar;60(3):319.
- Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Phillips KA, McElroy SL, Keck PE Jr, Pope HG Jr, Hudson JI. Body dysmorphic disorder: 30 cases of imagined ugliness. Am J Psychiatry. 1993 Feb;150(2):302-8. doi: 10.1176/ajp.150.2.302.
- Phillips KA, Albertini RS, Rasmussen SA. A randomized placebo-controlled trial of fluoxetine in body dysmorphic disorder. Arch Gen Psychiatry. 2002 Apr;59(4):381-8. doi: 10.1001/archpsyc.59.4.381.
- 2016. "Milk Thistle in Body Dysmorphic Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02843451.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
Does this trial permit those aged eighty-five and above to participate?
"This clinical trial has an age requirement of 18 to 65, whereas there are 4 separate trials for those younger and 8 for those older." - Anonymous Online Contributor