drugset / Trial / NCT02714543

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

NCT02714543

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2013-11
Primary completion
2015-08
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Aloe Vera Extract Unknown 5 mg Topical
Comparator Elemental copper Unknown 1 mg Oral
Comparator Elemental selenium Unknown 75 ug Oral
Comparator Hyaluronic Acid Other / unclassified 1500 iu Other
Comparator Hydrocortisone Other / unclassified 100 mg Other
Comparator Lycopene Other / unclassified 5 mg Oral
Comparator Vitamin E Other / unclassified 10 iu Oral
Comparator Zinc Sulfate Unknown 27.45 mg Oral
Subject aloevera juice Traditional medicine (herbal / TCM) 30 ml Oral
Comparator alpha-lipoic acid Small molecule 50 mg Oral
Comparator beta-carotene Small molecule 10 mg Oral