Trial · NCT02473913

Milk Thistle in Trichotillomania in Children and Adults

NCT02473913, Phase 2, Completed, University of Chicago; results first posted 2020-11-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Milk Thistle in Trichotillomania in Children and Adults. Trials, record NCT02473913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02473913

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Milk Thistle in Trichotillomania in Children and Adults
NCT number: NCT02473913
Status: Completed
Phases: Phase 2
Enrollment: 22 participants, actual
Lead sponsor: University of Chicago
Conditions: Trichotillomania, Hair Pulling Disorder
Interventions: Milk Thistle, Placebo
First posted: 2015-06-17
Last updated: 2020-11-20
Results first posted: 2020-11-04

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores	Baseline and 13 weeks	The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the NIMH-Trichotillomania Symptom Severity Scale (NIMH-TSS). The change in scores from baseline to after 13 weeks will be assessed. The NIMH-TSS consists of 5 questions related to the following aspects of TTM: average time spent pulling, time spent pulling on the previous day, resistance to urges, resulting distress and daily interference. NIMH-TSS scores range from 0 to 25, with higher scores indicating higher severity.
Secondary	Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)	Up to 13 weeks	The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the MGH-Hair Pulling Scale (MGH-HPS). At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. The MGH-HPS is a self report scale that assesses severity of Trichotillomania in the past week. There are seven total items each rated for severity from 0 to 4. Higher scores indicate higher symptom severity.
Secondary	Clinical Global Impression- Severity and Improvement (CGI)	Up to 13 weeks	The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the CGI. At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. The CGI-Severity is rated on a 7-point scale, with the severity of illness ranging from 1 (normal) through 7 (among the most severely ill patients). CGI-Change scores range from 1 (very much improved) through 7 (very much worse).
Secondary	Sheehan Disability Scale (SDS)	Up to 13 weeks	The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the Sheehan Disability Scale (SDS). At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. The scale itself assesses the level of functional impairment from trichotillomania (or target disorder). The subject is asked to rank the extent to which work/school, family life/home responsibilities, or social life are impaired by their symptoms on a scale from 0 (not at all) to 10 (extremely). The three numerical ratings can then be summed to produce a single measure of global functional impairment from 0 (unimpaired) to 30 (highly impaired).
Secondary	Hamilton Anxiety Rating Scale (HAM-A)	Up to 13 weeks	The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the Hamilton Anxiety Rating Scale (HAM-A), a 14 item scale. At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Secondary	Hamilton Depression Rating Scale (HAM-D)	Up to 13 weeks	The entire study for the subject will last 13 weeks. Every two weeks and after the one week washout period the subject will take the Hamilton Depression Rating Scale (HAM-D). At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. Classification of symptoms are scored as follows: 0 - absent: 1 - doubtful or trivial: 2 - present. Classification of symptoms where more detail can be obtained can be expanded to: 0 - absent; 1 - mild; 2 - moderate; 3 - severe; 4 - incapacitating. In general the higher the total score the more severe the depression. HAM-D score level of depression: 10 - 13 mild; 14-17 mild to moderate; \>17 moderate to severe.
Secondary	Trichotillomania Scale for Children/Parent (TSC-C & TSC-P)	Up to 13 weeks	The entire study for the subject will last 13 weeks. The subject will take the TSC-C (child version).The parent of the subject will fill out the TSC-P (parent version). At each of these visits the outcome will be assessed. Pre treatment and after the one week washout period scores reported. The scale itself assesses severity of trichotillomania and provides a sub score for severity. The severity score is produced by adding up the scores for questions 1 through 5 and dividing that sum by 5. The second sub score is on distress/impairment with questions such as "in the past week, how often did you feel like pulling your hair?". The sub score for distress/impairment is produced by adding the scores for questions 6-12 and dividing that sum by 7. The sum of both sub scores provides a total score. Total scores (ranging between 0 and 4) were compared pre treatment and post treatment. Higher scores indicate a higher severity and distress impairment score.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores	Baseline and 13 weeks		score on a scale	MEAN
SECONDARY	Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)	Up to 13 weeks		score on a scale	MEAN
SECONDARY	Clinical Global Impression- Severity and Improvement (CGI)	Up to 13 weeks		score on a scale	MEAN
SECONDARY	Sheehan Disability Scale (SDS)	Up to 13 weeks		score on a scale	MEAN
SECONDARY	Hamilton Anxiety Rating Scale (HAM-A)	Up to 13 weeks		score on a scale	MEAN
SECONDARY	Hamilton Depression Rating Scale (HAM-D)	Up to 13 weeks		score on a scale	MEAN
SECONDARY	Trichotillomania Scale for Children/Parent (TSC-C & TSC-P)	Up to 13 weeks	For some subjects, the scale was not filled out at follow-up visits (in error).	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores	Milk Thistle	Pre-Treatment	9.4	Standard Deviation 5.4	score on a scale
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores	Placebo	Pre-Treatment	9.4	Standard Deviation 5.0	score on a scale
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores	Milk Thistle	Post-Treatment	6.3	Standard Deviation 5.3	score on a scale
Change in NIMH Trichotillomania Severity Scale (NIMH-TSS) Scores	Placebo	Post-Treatment	7.4	Standard Deviation 5.1	score on a scale
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)	Milk Thistle	Pre-Treatment	13.5	Standard Deviation 6.8	score on a scale
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)	Placebo	Pre-Treatment	14.7	Standard Deviation 7.1	score on a scale
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)	Milk Thistle	Post-Treatment	10.4	Standard Deviation 7.6	score on a scale
Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)	Placebo	Post-Treatment	12.3	Standard Deviation 6.5	score on a scale
Clinical Global Impression- Severity and Improvement (CGI)	Milk Thistle	Pre-Treatment	4.1	Standard Deviation 1.0	score on a scale
Clinical Global Impression- Severity and Improvement (CGI)	Placebo	Pre-Treatment	3.9	Standard Deviation 0.6	score on a scale

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental: Milk Thistle, Then Placebo	11
Overall Study	STARTED	Experimetal: Placebo, Then Milk Thistle	11
Overall Study	COMPLETED	Experimental: Milk Thistle, Then Placebo	8
Overall Study	COMPLETED	Experimetal: Placebo, Then Milk Thistle	8
Overall Study	NOT COMPLETED	Experimental: Milk Thistle, Then Placebo	3
Overall Study	NOT COMPLETED	Experimetal: Placebo, Then Milk Thistle	3

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Milk Thistle	3	18	3
other	Nausea	Gastrointestinal disorders	Placebo	2	21	2
other	Bloating	Gastrointestinal disorders	Milk Thistle	1	18	1
other	Bloating	Gastrointestinal disorders	Placebo	1	21	1
other	Abdominal Pain	Gastrointestinal disorders	Milk Thistle	0	18	0
other	Abdominal Pain	Gastrointestinal disorders	Placebo	1	21	1
other	Dry Mouth	General disorders	Milk Thistle	0	18	0
other	Dry Mouth	General disorders	Placebo	1	21	1
other	Flatulence	Gastrointestinal disorders	Milk Thistle	0	18	0
other	Flatulence	Gastrointestinal disorders	Placebo	1	21	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Milk Thistle	0	18
Total, all-cause mortality	Placebo	0	21
Total, other adverse events	Milk Thistle	6	18
Total, other adverse events	Placebo	7	21
Total, serious adverse events	Milk Thistle	0	18
Total, serious adverse events	Placebo	0	21

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Milk Thistle vs Placebo: deaths from any cause	Trial comparisons
Milk Thistle vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02473913

GET https://conductscience.org/api/trials/v1/NCT02473913/results?page=2

API reference For AI assistants