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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nita Chainani Wu, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00525421
First received: September 4, 2007
Last updated: August 5, 2013
Last verified: August 2013
Results First Received: May 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Oral Lichen Planus
Interventions: Drug: Curcuminoids
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
23 patients with symptomatic oral lichen planus (OLP) presenting to the oral medicine clinic at the University of California, San Francisco (UCSF) between October 2007 and November 2008 were screening for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 patients had elevated liver enzymes at baseline and were excluded prior to randomization

Reporting Groups
  Description
Curcuminoid Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
Placebo Placebo : identical placebo tablets three times per day for 12 days

Participant Flow:   Overall Study
    Curcuminoid   Placebo
STARTED   10 [1]   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 
[1] Enrollment started october 2007



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Curcuminoid Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
Placebo Placebo : identical placebo tablets three times per day for 12 days
Total Total of all reporting groups

Baseline Measures
   Curcuminoid   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.2  (11.7)   60.8  (8.6)   58.5  (10.1) 
Gender 
[Units: Participants]
     
Female   8   5   13 
Male   2   5   7 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 
Symptom Score for OLP [1] 
[Units: Participants]
     
NRS 3-5   5   6   11 
NRS 5.5-8   5   4   9 
[1] Numerical Rating Scale (NRS): 0=No oral discomfort, 10=worst imaginable oral discomfort
Presence of Oral Ulcerations 
[Units: Participants]
     
Ulcerations at Baseline   3   4   7 
No Ulcerations at Baseline   7   6   13 
Past medication for OLP [1] 
[Units: Participants]
     
Topical Steroids   8   7   15 
No Topical Steroids   2   3   5 
Prednisone   6   5   11 
No Prednisone   4   5   9 
Azathioprine   1   1   2 
No Azathioprine   9   9   18 
Any Prior Medication for OLP   9   8   17 
No Prior Medication for OLP   1   2   3 
[1] Subjects who used medications in the past for OLP


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline to Two Weeks in Symptoms and Signs of Oral Lichen Planus (OLP)   [ Time Frame: 2 weeks ]

2.  Secondary:   Change in Serum C-reactive Protein and Serum Interleukin-6 Levels   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nita Chainani-Wu
Organization: University of California San Francisco
phone: 415-476-2045
e-mail: nita.wu@ucsf.edu


Publications of Results:
Other Publications:

Responsible Party: Nita Chainani Wu, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00525421     History of Changes
Other Study ID Numbers: H1113-30233-01
Study First Received: September 4, 2007
Results First Received: May 22, 2013
Last Updated: August 5, 2013