NCT02714543

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

Completed Phase 3 Last updated 15 March 2016

What this trial tests

Phase 3 trial testing aloevera juice in Oral SubMucous Fibrosis in 74 participants. Completed in 1 November 2015.

Timeline

1 November 2013

Primary endpoint
1 August 2015

1 November 2015

Quick facts

Lead sponsor	The Oxford Dental College, Hospital and Research Center, Bangalore, India
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	74
Start date	1 November 2013
Primary completion	1 August 2015
Estimated completion	1 November 2015

Drugs / interventions tested

• aloevera juice — full drug profile →
• Hydrocortisone (hydrocortisone) — full drug profile →
• Hyaluronic Acid (HYALURONIC ACID) — full drug profile →
• antioxidant — full drug profile →
• aloevera gel — full drug profile →

Conditions studied

• Oral SubMucous Fibrosis — all drugs for Oral SubMucous Fibrosis →

Sponsor

The Oxford Dental College, Hospital and Research Center, Bangalore, India

Who can join

Adults 17 to 60, any sex, with Oral SubMucous Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.