Oral Submucous FibrosisPhase 2NCT02645656
Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)
A Phase 2 study testing Curcumin Arm in people with Oral Submucous Fibrosis, run by SVS Institute of Dental Sciences at 1 site in India.
Trial summary
Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Read more about this study
- Who is it for?
- Ages 22 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Submucous Fibrosis
- What is being tested?
- Curcumin Arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2013to Feb 2016
- 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 22 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included.
Who cannot join
- Subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.
Trial locations and contacts
1 site in 1 country.
India1 site
SVS Institute of Dental Sciences, Mahabubnagar
Hyderabad, Andhra Pradesh, 509002
About this study
Official title: Topical Application of Curcumin Incorporated in Orabase in OSMF Patients
Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.
Read the detailed description
Anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of NF-κB and COX-2 (increased levels of COX-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines IL-1b, IL-6, and TNF-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase C, that mediate inflammation and tumor-cell proliferation.
Curcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. Antioxidants are implicated in the pathogenesis of OSMF and hence this preparation may be helpful in resolution of this lesion.
- Conditions
- Oral Submucous Fibrosis
- Being tested
- Curcumin Arm
- Keywords
- Oral Submucous Fibrosis, Curcumin
- 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.
Curcumin ArmDrug
Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals
| Study group | Role | What they receive |
|---|---|---|
| Curcumin Arm | Experimental | Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals. Receives: Drug: Curcumin Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in OSMF lesion
The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices.
Measured: up to 6 months
Secondary outcomes (1)
Jaw Opening
Jaw opening in mm will be measured at designated time intervals using an appropriate instrument.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startDec 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SVS Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr R Viswa Chandra, SVS Institute of Dental Sciences
- Investigators
- Ramaraju Devaraju, MDS, Study director, Academic Commitee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645656
- Sponsor's protocol ID
- SVSIDS/OMR/EX1/2013
- Status last verified
- Jan 2016
- First submitted
- 29 Dec 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be released after publishing the findings.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of Curcumin Incorporated in Orabase in OSMF Patients
- ClinicalTrials.gov ID
- NCT02645656
- Acronym / sponsor ID
- SVSIDS/OMR/EX1/2013
- Conditions
- Oral Submucous Fibrosis
- Keywords
- Oral Submucous Fibrosis, Curcumin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SVS Institute of Dental SciencesUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 5 Jan 2016 (estimated)
- 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.
Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.
Detailed description
Anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of NF-κB and COX-2 (increased levels of COX-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines IL-1b, IL-6, and TNF-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase C, that mediate inflammation and tumor-cell proliferation.
Curcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. Antioxidants are implicated in the pathogenesis of OSMF and hence this preparation may be helpful in resolution of this lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curcumin Arm | Experimental | Drug: Curcumin ArmCurcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included.
Key exclusion criteria (1 listed)
- Subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.
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 |
|---|---|---|
| Curcumin ArmCurcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals | Drug | Curcumin Arm |
Primary outcome
Reduction in OSMF lesion
Time frame: up to 6 months
The number of bands and the consistency of the lesion will be evaluated at designated time intervals using appropriate indices.
1 secondary outcome
Jaw Opening
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Individual participant dataSharing planned: No. Data will be released after publishing the findings.
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EVALUATION OF SALIVA AS LIQUID BIOPSY FOR EARLY DETECTION OF ORAL CANCER IN PATIENTS WITH ORAL-SUBMUCOUS FIBROSIS (OSMF)
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.
Ramaraju Devaraju, MDS study director
Academic Commitee
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 Curcumin Arm in people with Oral Submucous Fibrosis, run by SVS Institute of Dental Sciences 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 5 Jan 2016. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in OSMF lesion (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2016.