Oral SubMucous FibrosisPhase 3NCT02714543
Evaluation of Efficacy of Aloevera in the Treatment of Oral Submucous Fibrosis- A Clinical Study
A Phase 3 study testing aloevera juice, Hydrocortisone and Hyaluronic Acid in people with Oral SubMucous Fibrosis, run by The Oxford Dental College, Hospital and Research Center, Bangalore, India.
Trial summary
Oral submucous fibrosis is a chronic, insidious disease caused by arecanut use and is associated with both significant morbidity (including burning sensation and reduced oral opening) and an increased risk of malignancy. Read more about this study
- Who is it for?
- Ages 17 to 60 years
- Conditions the study is for
- Oral SubMucous Fibrosis
- What is being tested?
- aloevera juice, Hydrocortisone and Hyaluronic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Nov 2015
- Phase
- Phase 3
- 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 17 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinically diagnosed stage 2 OSMF patients.
- Patients who were ready to quit the habit and accept regular follow up protocol.
Who cannot join
- Patients with stage 1 \& 3 OSMF.
- Patients with history of hypersensitivity to aloevera.
- Pregnant women \& lactating mothers.
- Patients who had undergone any other treatment for OSMF.
About this study
Oral submucous fibrosis is a chronic, insidious disease caused by arecanut use and is associated with both significant morbidity (including burning sensation and reduced oral opening) and an increased risk of malignancy. Treatment of Oral SubMucous Fibrosis has largely been symptomatic and is associated with high recurrence rate. Aloevera has immunomodulatory, anti-inflammatory, wound healing, antioxidant and antineoplastic activities. All such properties of Aloevera suggest the possibility of its use in the management of oral submucous fibrosis.
In the present study, 74 patients of Oral SubMucous Fibrosis were randomly divided into 2 groups (Group A \& B). Group A patients were instructed to drink 30ml of aloe vera juice twice daily before food and to apply 5mg (approx 1 scoop) of aloe vera gel over the lesion 3-4 times daily for 3 months. Group B patients were given intralesional injections of 1.5ml Hydrocortisone acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were also prescribed SM Fibro (Alpha lipoic acid 50mg, Beta-carotene 10mg, Elemental copper 1mg, Elemental selenium 75mcg, Lycopene 5mg, Vitamin E 10 IU, Zinc sulphate 27.45mg in form of the capsule) for 3 months. Patients were assessed for burning sensation, interincisal mouthopening, cheek flexibility and tongue protrusion at an interval of 1, 2 and 3 months.
Read the detailed description
Material and Methods The present study was conducted in the Department of Oral Medicine and Radiology at The Oxford Dental College and Hospital, Bangalore, India between November 2013 to August 2015. Approval from the institutional ethical committee was obtained for the study. Patients with Oral SubMucous Fibrosis (Stage 2 according to Pindborg) were enrolled in the study. Pregnant women, lactating mothers, patients with known history of hypersensitivity to aloevera and those who had received prior treatment for OSMF were excluded. 74 patients who were ready to quit the habit and accept regular follow up treatment protocol were included in the study. An informed consent was obtained from all the patients after the nature of the study and its procedures were explained. A thorough clinical examination was done and the following parameters were measured and recorded by an independent examiner.
- The intensity of burning sensation was recorded using a Numerical Rating Visual Analogue Scale.
- The interincisal mouth opening was measured using a metal scale and divider from the mesioincisal angle of upper central incisor to the mesioincisal angle of lower central incisor and recorded in millimeters.
- Cheek flexibility (CF) was measured according to the method described by Bailoor and Nagesh. Two points were marked, one on each side of the face at 1/3rd the distance from angle of the mouth on a line joining the tragus of the ear and the angle of the mouth. The distance measured between these two points was V2. The subject was asked to blow his cheek fully and the distance measured between the same two points was V1. CF=V2-V1.
- Tongue protrusion was assessed from normal mesioincisal angle of upper central incisor to the tip of the tongue when maximally extended with mouth wide open.
The patients were randomly divided into 2 groups (Group A \& B). Group A patients were given pure aloevera gel and pure aloevera juice (Processed and manufactured by Hemant Sai, Sun Vision Company, Neel RLI Pvt Ltd). They were instructed to drink 30ml of aloevera juice twice daily before food and to apply 5mg (approx 1 scoop) of aloevera gel over the lesion 3 times per day for 3 months. Group B patients were given intralesional injections of Hydrocortisone acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were also prescribed Cap SM Fibro twice daily for 3 months. Same baseline parameters were measured and recorded at an interval of 1, 2 \& 3 months by the same examiner who measured the baseline values and was unaware of the treatment received by the study subjects.
- Conditions
- Oral SubMucous Fibrosis
- Being tested
- aloevera juice, Hydrocortisone, Hyaluronic Acid, antioxidant, aloevera gel
- Keywords
- OSMF, Aloevera, Hydrocortisone, Hyaluronidase
- 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.
aloevera juiceDrug
aloevera juice to drink twice daily for 3 months.
HydrocortisoneDrug
intralesional injection of hydrocortisone 100mg once a week for 6 weeks
Hyaluronic AcidDrug
injection hyaluronic acid 1500IU once a week for 6 weeks
antioxidantDrug
Also called Capsule SM Fibro
Capsules SM Fibro (antioxidants) once daily for 3 months.
aloevera gelDrug
aloevera gel one scoop to be applied 3-4 times daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| aloevera group | Experimental | aloevera juice twice daily for 3 months. aloevera gel one scoop to be applied 3-4 times daily for 3 months Receives: Drug: aloevera juice; Drug: aloevera gel |
| steroid group | Active comparator | intralesional injection of hydrocortisone 100mg and injection hyaluronic acid 1500IU once a week for 6 weeks with Capsules SM Fibro once daily for 3 months. Receives: Drug: Hydrocortisone; Drug: Hyaluronic Acid; Drug: antioxidant |
What is being measured
The primary outcome is the main question the study is designed to answer.
burning sensation
Visual analogue scale
Measured: 3 months
mouth opening
interincisal mouth opening was measured using a metal scale and divider from the mesioincisal angle of upper central incisor to the mesioincisal angle of lower central incisor and recorded in millimeters
Measured: 3 months
cheek flexibility
Two points were marked, one on each side of the face at 1/3rd the distance from angle of the mouth on a line joining the tragus of the ear and the angle of the mouth. The distance measured between these two points was V2. The subject was asked to blow his cheek fully and the distance measured between the same two points was V1. CF=V2-V1. measured in milimeters
Measured: 3 months
tongue protrusion
from mesioincisal angle of upper central incisor to the tip of the tongue when maximally extended with mouth wide open. measured in milimeters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionNov 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Oxford Dental College, Hospital and Research Center, Bangalore, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anuradha Pai, The Oxford Dental College, Hospital and Research Center, Bangalore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714543
- Sponsor's protocol ID
- OxfordDC
- Status last verified
- Mar 2016
- First submitted
- 19 Feb 2016
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Aloevera in the Treatment of Oral Submucous Fibrosis- A Clinical Study
- ClinicalTrials.gov ID
- NCT02714543
- Acronym / sponsor ID
- OxfordDC
- Conditions
- Oral SubMucous Fibrosis
- Keywords
- OSMF, Aloevera, Hydrocortisone, Hyaluronidase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The Oxford Dental College, Hospital and Research Center, Bangalore, IndiaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Mar 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.
Oral submucous fibrosis is a chronic, insidious disease caused by arecanut use and is associated with both significant morbidity (including burning sensation and reduced oral opening) and an increased risk of malignancy. Treatment of Oral SubMucous Fibrosis has largely been symptomatic and is associated with high recurrence rate. Aloevera has immunomodulatory, anti-inflammatory, wound healing, antioxidant and antineoplastic activities. All such properties of Aloevera suggest the possibility of its use in the management of oral submucous fibrosis.
In the present study, 74 patients of Oral SubMucous Fibrosis were randomly divided into 2 groups (Group A \& B). Group A patients were instructed to drink 30ml of aloe vera juice twice daily before food and to apply 5mg (approx 1 scoop) of aloe vera gel over the lesion 3-4 times daily for 3 months. Group B patients were given intralesional injections of 1.5ml Hydrocortisone acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were also prescribed SM Fibro (Alpha lipoic acid 50mg, Beta-carotene 10mg, Elemental copper 1mg, Elemental selenium 75mcg, Lycopene 5mg, Vitamin E 10 IU, Zinc sulphate 27.45mg in form of the capsule) for 3 months. Patients were assessed for burning sensation, interincisal mouthopening, cheek flexibility and tongue protrusion at an interval of 1, 2 and 3 months.
Detailed description
Material and Methods The present study was conducted in the Department of Oral Medicine and Radiology at The Oxford Dental College and Hospital, Bangalore, India between November 2013 to August 2015. Approval from the institutional ethical committee was obtained for the study. Patients with Oral SubMucous Fibrosis (Stage 2 according to Pindborg) were enrolled in the study. Pregnant women, lactating mothers, patients with known history of hypersensitivity to aloevera and those who had received prior treatment for OSMF were excluded. 74 patients who were ready to quit the habit and accept regular follow up treatment protocol were included in the study. An informed consent was obtained from all the patients after the nature of the study and its procedures were explained. A thorough clinical examination was done and the following parameters were measured and recorded by an independent examiner.
- The intensity of burning sensation was recorded using a Numerical Rating Visual Analogue Scale.
- The interincisal mouth opening was measured using a metal scale and divider from the mesioincisal angle of upper central incisor to the mesioincisal angle of lower central incisor and recorded in millimeters.
- Cheek flexibility (CF) was measured according to the method described by Bailoor and Nagesh. Two points were marked, one on each side of the face at 1/3rd the distance from angle of the mouth on a line joining the tragus of the ear and the angle of the mouth. The distance measured between these two points was V2. The subject was asked to blow his cheek fully and the distance measured between the same two points was V1. CF=V2-V1.
- Tongue protrusion was assessed from normal mesioincisal angle of upper central incisor to the tip of the tongue when maximally extended with mouth wide open.
The patients were randomly divided into 2 groups (Group A \& B). Group A patients were given pure aloevera gel and pure aloevera juice (Processed and manufactured by Hemant Sai, Sun Vision Company, Neel RLI Pvt Ltd). They were instructed to drink 30ml of aloevera juice twice daily before food and to apply 5mg (approx 1 scoop) of aloevera gel over the lesion 3 times per day for 3 months. Group B patients were given intralesional injections of Hydrocortisone acetate 25mg/ml and hyaluronidase (1500 IU) weekly for 6 weeks. They were also prescribed Cap SM Fibro twice daily for 3 months. Same baseline parameters were measured and recorded at an interval of 1, 2 \& 3 months by the same examiner who measured the baseline values and was unaware of the treatment received by the study subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aloevera group | Experimental | Drug: aloevera juice, Drug: aloevera gelaloevera juice twice daily for 3 months. aloevera gel one scoop to be applied 3-4 times daily for 3 months |
| steroid group | Active comparator | Drug: Hydrocortisone, Drug: Hyaluronic Acid, Drug: antioxidantintralesional injection of hydrocortisone 100mg and injection hyaluronic acid 1500IU once a week for 6 weeks with Capsules SM Fibro once daily for 3 months. |
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinically diagnosed stage 2 OSMF patients.
- Patients who were ready to quit the habit and accept regular follow up protocol.
Key exclusion criteria (4 listed)
- Patients with stage 1 \& 3 OSMF.
- Patients with history of hypersensitivity to aloevera.
- Pregnant women \& lactating mothers.
- Patients who had undergone any other treatment for OSMF.
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 |
|---|---|---|
| aloevera juicealoevera juice to drink twice daily for 3 months. | Drug | aloevera group |
| Hydrocortisoneintralesional injection of hydrocortisone 100mg once a week for 6 weeks | Drug | steroid group |
| Hyaluronic Acidinjection hyaluronic acid 1500IU once a week for 6 weeks | Drug | steroid group |
| antioxidantAlso: Capsule SM FibroCapsules SM Fibro (antioxidants) once daily for 3 months. | Drug | steroid group |
| aloevera gelaloevera gel one scoop to be applied 3-4 times daily for 3 months | Drug | aloevera group |
Primary outcome
burning sensation
Time frame: 3 months
Visual analogue scale
mouth opening
Time frame: 3 months
interincisal mouth opening was measured using a metal scale and divider from the mesioincisal angle of upper central incisor to the mesioincisal angle of lower central incisor and recorded in millimeters
cheek flexibility
Time frame: 3 months
Two points were marked, one on each side of the face at 1/3rd the distance from angle of the mouth on a line joining the tragus of the ear and the angle of the mouth. The distance measured between these two points was V2. The subject was asked to blow his cheek fully and the distance measured between the same two points was V1. CF=V2-V1. measured in milimeters
tongue protrusion
Time frame: 3 months
from mesioincisal angle of upper central incisor to the tip of the tongue when maximally extended with mouth wide open. measured in milimeters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aloevera juice, Hydrocortisone and Hyaluronic Acid in people with Oral SubMucous Fibrosis, run by The Oxford Dental College, Hospital and Research Center, Bangalore, 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
burning sensation (time frame: 3 months). The study lists 4 primary outcomes in all. 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 21 Mar 2016.