Efficacy of Curcumin in Oral Submucous Fibrosis (ECOSMF)
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|ClinicalTrials.gov Identifier: NCT03511261|
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oral Submucous Fibrosis||Drug: 10% Curcumin mucoadhesive gel Drug: Curcumin capsules 500mg Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg Drug: Placebo capsule||Phase 2|
200 clinical stage 2 OSMF patients selected randomly by simple random technique with clinically & histopathologically confirmed diagnosis are divided into 4 groups with 50 patients each.
In Group 1 patients are given 10% of curcumin mucoadhesive gel and are instructed to use it topically twice daily making it a daily dose of 1gm.
In Group 2 patients are given 500mg of curcumin capsules and are instructed to take 2 capsules twice daily making a daily dose of 1gm.
In Group 3 patients will be given 5% of curcumin mucoadhesive gel and will be instructed to use it topically twice daily & 250mg of curcumin capsules to be taken twice daily making it a daily dose of 1gm.
Group 4 is considered as control group and provided with formulations without the active drug.
The mean scores of 4 groups will be statistically tested using Anova technique.
The differences in clinical parameters at 15 days, 1 month, 3 months & clinical & histopathological paramerters at 6 months will be compared between groups 1, 2, 3 & 4 by using students 't' test & correlation is also used for knowing the association of variables.
For all tests, a 'p' value of 0.05 or less will be utilized for statistical significance.
Other non parametric tests can also be applied where ever necessary for data analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||four groups, each group with different formulations.|
|Masking Description:||single blinded|
|Official Title:||Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: 10%Curcumin mucoadhesive gel
Drug: Curcumin arm Curcumin10% mucoadhesive gel
Group 1 patients:
Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months
Drug: 10% Curcumin mucoadhesive gel
Group 1 10%of mucoadhesive gel for topical application two times per day.
Other Name: curcuminoid
Active Comparator: Curcumin capsules 500mg
Group 2 patients:
Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Drug: Curcumin capsules 500mg
Group 2 curcumin 500 mg capsules for oral intake two times per day
Other Name: curcuminoid
Active Comparator: 5% Curcumin gel+Curcumin capsules 250mg
Group 3 patients:
Drug: 5% Curcumin mucoadhesive gel & Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months
Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day
Other Name: curcuminoid
Placebo Comparator: Placebo capsules
Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Drug: Placebo capsule
Group 4 placebo capsules for oral intake two times per day
Other Name: non curcuminoid
- Burning sensation and pain [ Time Frame: 6 months for each patient ]Visual Analogue Scale
- Interincisal distance, tongue protrusion and cheek flexibility [ Time Frame: 6 months for each patient ]All these will be measured in mm at designated time intervals using digital vernier calliper.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511261
|Contact: Jayashree Mudda, MDSfirstname.lastname@example.org|
|HKE'S S.N Institute of dental sciences & research center||Recruiting|
|Gulbarga, Karnataka, India, 585102|
|Contact: Jayashree Mudda, MDS +919741804012 email@example.com|
|Principal Investigator:||Syeda Arshiya Ara, MDS||HKE'S S.N Institute of dental sciences & research center|