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

NCT02714543 | Completed Phase 3

• 1 other identifier: OxfordDC
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Oral SubMucous Fibrosis

Keywords

OSMF; Aloevera; Hydrocortisone; Hyaluronidase

Outcome Measures

Primary Outcomes (4)

• burning sensation

  Visual analogue scale

  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

  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

  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

  3 months

Study Arms (2)

aloevera group

EXPERIMENTAL

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

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.

Drug: Hydrocortisone; Drug: Hyaluronic Acid; Drug: antioxidant

Interventions

aloevera juice DRUG

aloevera juice to drink twice daily for 3 months.

aloevera group

Hydrocortisone DRUG

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

steroid group

Hyaluronic Acid DRUG

injection hyaluronic acid 1500IU once a week for 6 weeks

steroid group

antioxidant DRUG

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

Also known as: Capsule SM Fibro

steroid group

aloevera gel DRUG

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

aloevera group

Eligibility Criteria

• Age: 17 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Oxford Dental College, Hospital and Research Center, Bangalore, India: lead

MeSH Terms

Conditions

Oral Submucous Fibrosis

Interventions

Hydrocortisone; Hyaluronic Acid; Antioxidants

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Glycosaminoglycans; Polysaccharides; Carbohydrates; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Dept of oral medicine and radiology

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 21, 2016
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 21, 2016

Record last verified: 2016-03