Abstract

ASSESSMENT OF THE EFFICACY AND SAFETY OF SNEC 30 (CURCUMA LONGA) CAPSULES AND SNEC ORAL GEL TOPICAL APPLICATION IN THE TREATMENT OF ORAL SUBMUCOUS FIBROSIS: A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY

Narsingh Verma, Smriti Rastogi*, Vandana Awasthi Abhinav Verma, Dr. Saurabh Arora and Dr. Neha Arora

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Abstract

Background and Aim: Oral submucous fibrosis (OSMF) is a prevalent potentially malignant disorder associated with betel quid chewing frequently observed in the Indian population. The present study aims to evaluate the efficacy and safety of snec 30 (curcuma longa) capsules and snec oral gel topical application in the treatment of oral Submucous fibrosis in a prospective, comparative, randomized study. Materials and Methods: Seventy nine patients were divided randomly into two groups treatment arm A and treatment arm B. After fulfilling the eligibility criteria, subjects were randomly allotted into two groups: thirty nine patients in Treatment Arm A and forty patients in Treatment Arm B. Treatment Arm A subjects received 2 capsules of SNEC30 (curcumin therapy) twice daily with 240 ml water and SNEC ORAL GEL for local application 3 times a day for 12 weeks and Arm B received conventional treatment (prescribed by the investigator). Body weight and height were measured, physical examination was performed, and vital signs including blood pressure and heart rate were recorded. Laboratory parameters were performed at the time of screening. VAS (Visual analog scale) was used as a measure of burning sensation, mouth opening measurement was done in both groups viz., Treatment group A & Treatment group B. The statistical analysis was done using SPSS Version 22.0 statistical Analysis Software. Results: In Group A, the initial burning sensation was 8.4 ± 1.2%, and in Group B, it was 8.76 ± 1.51% (as measured through the visual analog scale). After 3 months, there was complete cessation of burning sensation in treatment arm A. Decrease in burning sensation between the groups was statistically significant (p > 0.05). In Group A, mean mouth opening at baseline (1st visit) was 3.35 ± 1.07 cm which improved to 3.77 ± 1.22 cm after 3 months of the treatment period. In Group B, mean mouth opening at baseline (1st visit) observed was 3.92 ± 1.66 cm which improved to 3.17 ± 1.48 cm after 3 months of the treatment period. On comparing intergroup, the difference was statistically non significant (P > 0.05). However, on comparing intergroup, average percent change in mean mouth opening from 1st visit to subsequent time intervals across the time period was found to be statistically significant (P < 0.05). Conclusion: SNEC 30 capsule and SNEC gel (Test formulations) showed better results than conventional treatment in improving mouth opening; also test formulations were more effective in decreasing burning sensation in OSMF patients.

Keywords: Curcumin, oral submucous fibrosis, self nano emulsifying curcumin.