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CompletedNCT02714543Updated Mar 21, 2016

Evaluation of Efficacy of Aloevera in the Treatment of Oral Submucous Fibrosis- A Clinical Study

A Phase 3 interventional study of aloevera juice and Hydrocortisone in Oral SubMucous Fibrosis, sponsored by The Oxford Dental College, Hospital and Research Center, Bangalore, India. Completed. Open to participants aged 17 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-03-21.

Sponsored by The Oxford Dental College, Hospital and Research Center, Bangalore, India · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
17 Years to 60 Years
Sex
All
01

Study 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. 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.

  1. The intensity of burning sensation was recorded using a Numerical Rating Visual Analogue Scale.
  2. 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.
  3. 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.
  4. 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.

02

Conditions studied

  • Oral SubMucous Fibrosis

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Keywords

  • OSMF
  • Aloevera
  • Hydrocortisone
  • Hyaluronidase
03

In context

Fibrosis

3,256 studies on the registry are indexed under Fibrosis; 466 are open to participants now.

This study's enrollment of 74 is above the median of 50 across 2,130 interventional studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

The Oxford Dental College, Hospital and Research Center, Bangalore, India is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Clinically diagnosed stage 2 OSMF patients.
  2. Patients who were ready to quit the habit and accept regular follow up protocol.

Exclusion criteria

Exclusion Criteria:

  1. Patients with stage 1 \& 3 OSMF.
  2. Patients with history of hypersensitivity to aloevera.
  3. Pregnant women \& lactating mothers.
  4. Patients who had undergone any other treatment for OSMF.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    aloevera group

    aloevera juice twice daily for 3 months. aloevera gel one scoop to be applied 3-4 times daily for 3 months

    Drug: aloevera juice · Drug: aloevera gel

  • Active comparator
    steroid group

    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.

    Drug: Hydrocortisone · Drug: Hyaluronic Acid · Drug: antioxidant

Interventions

  • Drugaloevera juice

    aloevera juice to drink twice daily for 3 months.

  • DrugHydrocortisone

    intralesional injection of hydrocortisone 100mg once a week for 6 weeks

  • DrugHyaluronic Acid

    injection hyaluronic acid 1500IU once a week for 6 weeks

  • Drugantioxidant

    Capsules SM Fibro (antioxidants) once daily for 3 months.

    Also known as: Capsule SM Fibro

  • Drugaloevera gel

    aloevera gel one scoop to be applied 3-4 times daily for 3 months

06

What researchers measure

Primary outcomes

  1. burning sensation

    Visual analogue scale

    Time frame: 3 months

  2. 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

    Time frame: 3 months

  3. 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

    Time frame: 3 months

  4. 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

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02714543
Lead sponsor
The Oxford Dental College, Hospital and Research Center, Bangalore, India
Responsible party
Dr. Anuradha Pai (Professor and Head, Dept of oral medicine and radiology, The Oxford Dental College, Hospital and Research Center, Bangalore, India) — Principal investigator
First posted
Mar 21, 2016
Start date
Nov 2013
Primary completion
Aug 2015
Completion
Nov 2015
Last update
Mar 21, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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