Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2014-01-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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
10% Curcumin mucoadhesive gel
Group 1 10%of mucoadhesive gel for topical application two times per day.
Curcumin capsules 500mg
Group 2 patients:
Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Curcumin capsules 500mg
Group 2 curcumin 500 mg capsules for oral intake two times per day
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
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
Placebo capsules
Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months
Placebo capsule
Group 4 placebo capsules for oral intake two times per day
Interventions
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10% Curcumin mucoadhesive gel
Group 1 10%of mucoadhesive gel for topical application two times per day.
Curcumin capsules 500mg
Group 2 curcumin 500 mg capsules for oral intake two times per day
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
Placebo capsule
Group 4 placebo capsules for oral intake two times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
14 Years
45 Years
ALL
No
Sponsors
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H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
OTHER
Responsible Party
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Syeda Arshiya Ara
Professor & Research scholar
Principal Investigators
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Syeda Arshiya Ara, MDS
Role: PRINCIPAL_INVESTIGATOR
HKE'S S.N Institute of dental sciences & research center
Locations
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HKE'S S.N Institute of dental sciences & research center
Kalaburagi, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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References
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Hazarey VK, Sakrikar AR, Ganvir SM. Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial. J Oral Maxillofac Pathol. 2015 May-Aug;19(2):145-52. doi: 10.4103/0973-029X.164524.
Other Identifiers
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HKESSNDCG/OMR/2014/CT1
Identifier Type: -
Identifier Source: org_study_id
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