Oral Submucous FibrosisPhase 2ECOSMFNCT03511261
Efficacy of Curcumin in Oral Submucous Fibrosis
A Phase 2 study testing 10% Curcumin mucoadhesive gel, Curcumin capsules 500mg and 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg in people with Oral Submucous Fibrosis, run by H.K.E.S's S.Nijalingappa Institute of Dental Science and Research at 1 site in India.
Trial summary
The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF). Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Oral Submucous Fibrosis
- What is being tested?
- 10% Curcumin mucoadhesive gel, Curcumin capsules 500mg and 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2014to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 200 clinical stage 2 OSMF patients
Who cannot join
- Clinical stage 1 \& 3 OSMF patients, oromucosal disorders with clinical features same as OSMF, patients who are under treatment, clinically diagnosed cases not ready for incisional biopsy, patients suffering from medically compromised conditions.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
HKE'S S.N Institute of dental sciences & research center
Kalaburagi, Karnataka, 585102
Jayashree Mudda, MDS, +919741804012, jayashreemudda@gmail.com
About this study
Official title: Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.
The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF).
Read the detailed description
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.
- Conditions
- Oral Submucous Fibrosis
- Being tested
- 10% Curcumin mucoadhesive gel, Curcumin capsules 500mg, 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg, Placebo capsule
- Keywords
- Oral submucous fibrosis, curcumin, potentially malignant disease
- Medical subject headings
- Oral Submucous Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Curcumin mucoadhesive gelDrug
Also called curcuminoid
Group 1 10%of mucoadhesive gel for topical application two times per day.
Curcumin capsules 500mgDrug
Also called curcuminoid
Group 2 curcumin 500 mg capsules for oral intake two times per day
5% curcumin mucoadhesive gel + Curcumin capsules 250 mgDrug
Also called curcuminoid
Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day
Placebo capsuleDrug
Also called non curcuminoid
Group 4 placebo capsules for oral intake two times per day
| Study group | Role | What they receive |
|---|---|---|
| 10%Curcumin mucoadhesive gel | Active comparator | Drug: Curcumin arm Curcumin10% mucoadhesive gel
Group 1 patients:
Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months Receives: Drug: 10% Curcumin mucoadhesive gel |
| Curcumin capsules 500mg | Active comparator | Group 2 patients:
Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months Receives: Drug: Curcumin capsules 500mg |
| 5% Curcumin gel+Curcumin capsules 250mg | Active comparator | Group 3 patients:
Drug: 5% Curcumin mucoadhesive gel \& Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months Receives: Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg |
| Placebo capsules | Placebo comparator | Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burning sensation and pain
Visual Analogue Scale
Measured: 6 months for each patient
Secondary outcomes (1)
Interincisal distance, tongue protrusion and cheek flexibility
All these will be measured in mm at designated time intervals using digital vernier calliper.
Measured: 6 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Submucous FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- four groups, each group with different formulations.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syeda Arshiya Ara, H.K.E.S's S.Nijalingappa Institute of Dental Science and Research
- Investigators
- Syeda Arshiya Ara, MDS, Principal investigator, HKE'S S.N Institute of dental sciences & research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511261
- Sponsor's protocol ID
- HKESSNDCG/OMR/2014/CT1
- Acronym
- ECOSMF
- Status last verified
- Apr 2018
- First submitted
- 27 Jan 2017
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26604488
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.
- ClinicalTrials.gov ID
- NCT03511261
- Acronym / sponsor ID
- ECOSMF / HKESSNDCG/OMR/2014/CT1
- Conditions
- Oral Submucous Fibrosis
- Keywords
- Oral submucous fibrosis, curcumin, potentially malignant disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- H.K.E.S's S.Nijalingappa Institute of Dental Science and ResearchUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- four groups, each group with different formulations.
| Arm | Type | Receives |
|---|---|---|
| 10%Curcumin mucoadhesive gel | Active comparator | Drug: 10% Curcumin mucoadhesive gelDrug: Curcumin arm Curcumin10% mucoadhesive gel Group 1 patients: Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months |
| Curcumin capsules 500mg | Active comparator | Drug: Curcumin capsules 500mgGroup 2 patients: Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months |
| 5% Curcumin gel+Curcumin capsules 250mg | Active comparator | Drug: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mgGroup 3 patients: Drug: 5% Curcumin mucoadhesive gel \& Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months |
| Placebo capsules | Placebo comparator | Drug: Placebo capsuleGroup 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 200 clinical stage 2 OSMF patients
Key exclusion criteria (1 listed)
- Clinical stage 1 \& 3 OSMF patients, oromucosal disorders with clinical features same as OSMF, patients who are under treatment, clinically diagnosed cases not ready for incisional biopsy, patients suffering from medically compromised conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% Curcumin mucoadhesive gelAlso: curcuminoidGroup 1 10%of mucoadhesive gel for topical application two times per day. | Drug | 10%Curcumin mucoadhesive gel |
| Curcumin capsules 500mgAlso: curcuminoidGroup 2 curcumin 500 mg capsules for oral intake two times per day | Drug | Curcumin capsules 500mg |
| 5% curcumin mucoadhesive gel + Curcumin capsules 250 mgAlso: curcuminoidGroup 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day | Drug | 5% Curcumin gel+Curcumin capsules 250mg |
| Placebo capsuleAlso: non curcuminoidGroup 4 placebo capsules for oral intake two times per day | Drug | Placebo capsules |
Primary outcome
Burning sensation and pain
Time frame: 6 months for each patient
Visual Analogue Scale
1 secondary outcome
Interincisal distance, tongue protrusion and cheek flexibility
Time frame: 6 months for each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Background: PubMed 26604488Hazarey 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.
- Individual participant dataSharing planned: No
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The Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syeda Arshiya Ara, MDS principal investigator
HKE'S S.N Institute of dental sciences & research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10% Curcumin mucoadhesive gel, Curcumin capsules 500mg and 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg in people with Oral Submucous Fibrosis, run by H.K.E.S's S.Nijalingappa Institute of Dental Science and Research at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayashree Mudda, MDS (+919741804012, jayashreemudda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burning sensation and pain (time frame: 6 months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03511261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.