Trial · NCT00525421

A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus

NCT00525421, Phase 2, Completed, Nita Chainani Wu; results first posted 2013-08-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus. Trials, record NCT00525421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00525421

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Trial

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

Title: A Clinical Study of Curcuminoids in the Treatment of Oral Lichen Planus
NCT number: NCT00525421
Status: Completed
Phases: Phase 2
Enrollment: 20 participants, actual
Lead sponsor: Nita Chainani Wu
Conditions: Oral Lichen Planus
Interventions: Curcuminoids, Placebo
First posted: 2007-09-05
Last updated: 2013-08-07
Results first posted: 2013-08-07

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	2 weeks	Numeric Rating Scale (NRS) is patient-reported numerical score for intensity of symptoms (range 0-10, where 0=no oral discomfort and 10=worst imaginable oral discomfort; symptom score over the last 1 week was recorded at baseline, and symptom score since baseline was recorded at follow-up. For Modified Oral Mucositis Index (MOMI) each of 16 oral sites is scored by an examiner for both erythema intensity (range 0-3 where 0=normal, 1=mild, 2=moderate, 3=severe) and area of ulceration (range 0-3 where 0=none, 1=\>0-0.25 cm\^2, 2= \>0.25-1 cm\^2, 3=\>=1cm\^2): right (R) and left (L) buccal mucosa, labial mucosa (upper and lower), lateral tongue (R and L), dorsum of tongue (R and L), ventral tongue and floor of mouth (R and L), maxillary gingiva (R and L), mandibular gingiva (R and L), and soft and hard palate. Total score for clinical signs (MOMI) is the sum of scores for 16 sites; separate scores for erythema and ulceration are the sums of respective scores.
Secondary	Change in Serum C-reactive Protein and Serum Interleukin-6 Levels	2 weeks	Percentage changes from baseline to two weeks in C-Reactive protein (CLP) and interleukin-6 (IL-6).

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	2 weeks		percent change	MEDIAN
SECONDARY	Change in Serum C-reactive Protein and Serum Interleukin-6 Levels	2 weeks		Percent change	MEDIAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	Curcuminoid	NRS	-22	Inter-Quartile Range -33 to -14	percent change
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	Placebo	NRS	0	Inter-Quartile Range -29 to 16.7	percent change
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	Curcuminoid	Erythema	-17	Inter-Quartile Range -29 to -8.3	percent change
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	Placebo	Erythema	0	Inter-Quartile Range -10 to 16.7	percent change
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	Curcuminoid	Ulceration	-14	Inter-Quartile Range -60 to 0	percent change
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	Placebo	Ulceration	0	Inter-Quartile Range 0 to 26.7	percent change
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	Curcuminoid	MOMI	-24	Inter-Quartile Range -38 to -11	percent change
Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)	Placebo	MOMI	-3.2	Inter-Quartile Range -13 to 9.09	percent change
Change in Serum C-reactive Protein and Serum Interleukin-6 Levels	Curcuminoid	CRP	0	Inter-Quartile Range -21 to 19	Percent change
Change in Serum C-reactive Protein and Serum Interleukin-6 Levels	Placebo	CRP	33.3	Inter-Quartile Range 0 to 50	Percent change

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Curcuminoid	10
Overall Study	STARTED	Placebo	10
Overall Study	COMPLETED	Curcuminoid	10
Overall Study	COMPLETED	Placebo	10
Overall Study	NOT COMPLETED	Curcuminoid	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events12

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	Diarrhea	Gastrointestinal disorders	Curcuminoid	2	10	2
other	Diarrhea	Gastrointestinal disorders	Placebo	1	10	1
other	Constipation	Gastrointestinal disorders	Curcuminoid	1	10	1
other	Constipation	Gastrointestinal disorders	Placebo	1	10	1
other	Abdominal pain	Gastrointestinal disorders	Curcuminoid	1	10	1
other	Abdominal pain	Gastrointestinal disorders	Placebo	0	10	0
other	Heartburn	Gastrointestinal disorders	Curcuminoid	1	10	1
other	Heartburn	Gastrointestinal disorders	Placebo	0	10	0
other	Nausea	Gastrointestinal disorders	Curcuminoid	1	10	1
other	Nausea	Gastrointestinal disorders	Placebo	0	10	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Curcuminoid
Total, all-cause mortality	Placebo
Total, other adverse events	Curcuminoid	4	10
Total, other adverse events	Placebo	2	10
Total, serious adverse events	Curcuminoid	0	10
Total, serious adverse events	Placebo	0	10

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
12676044	BACKGROUND	PubMed
17604143	BACKGROUND	PubMed
21907450	RESULT	PubMed

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 comparisons1

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

Comparison
Curcuminoid vs Placebo: serious adverse events

Source 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/NCT00525421

GET https://conductscience.org/api/trials/v1/NCT00525421/registered

API reference For AI assistants