Comparative Effect of Nigella Sativa and Conventional Management for OSMF
Słowa kluczowe
Abstrakcyjny
Opis
OSMF is a chronic insidious disorder of the oral cavity which has a great potential to turn malignant. The clinical manifestations of OSMF comprise of white, marble-like appearance of the oral mucosa with loss of flexibility and formation of palpable fibrous bands extending from the anterior to the posterior region of the oral cavity.Other features include burning sensation on taking spicy food, loss of papillae of the tongue, loss of natural pigmentation of the lips and restricted mouth opening.
There is no definitive treatment available for OSMF due to its complex etiology. The most essential component in the management of OSMF is the discontinuation of the habit of areca nut chewing by the patient followed by conservative or surgical treatment. Currently, steroids are the most commonly used drug group in managing OSMF because of their ability to reduce the inflammatory process and increasing the apoptosis of inflammatory cells thereby decreasing fibrosis. However, they are not very useful in reversing the pathology and restoring mucosal elasticity and can cause mucosal thinning with long term use ultimately resulting in worsening of the symptoms of the disease.
Many in- vitro and in- vivo studies have been conducted to establish the anti neoplastic, anti inflammatory, immunomodulatory, antihypertensive, antimicrobial, anti-parasitic, antioxidant and hypoglycemic properties of N.sativa oil. Among all the constituents of Nigella sativa, Thymoquinone (Tq) is the most pharmacologically active constituent responsible for most of its properties. Nigella sativa has been used widely in different food preparations in the form of a flavoring agent or a spice. It is also recognized as 'safe' in the inventory of United States Food and Drug administration.
Daktyle
| Ostatnia weryfikacja: | 06/30/2020 |
| Pierwsze przesłane: | 07/01/2020 |
| Szacowana liczba przesłanych rejestracji: | 07/13/2020 |
| Wysłany pierwszy: | 07/19/2020 |
| Ostatnia aktualizacja przesłana: | 07/13/2020 |
| Ostatnia opublikowana aktualizacja: | 07/19/2020 |
| Rzeczywista data rozpoczęcia badania: | 07/31/2020 |
| Szacowana data zakończenia podstawowej działalności: | 07/31/2021 |
| Szacowana data zakończenia badania: | 11/30/2021 |
Stan lub choroba
Interwencja / leczenie
Dietary Supplement: Group 2
Drug: Group 1
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Active Comparator: Group 1 Participants in group 1 will be given corticosteroid lotion (Betamethasone valerate 0.1%) and will be advised to apply it topically (0.5 ml) on the buccal mucosa thrice a day along with physiotherapy using ice cream sticks three times a day for the duration of 10 minutes (3-5minutes on each side). | Drug: Group 1 it is a conventionally used drug for treating OSMF |
| Experimental: Group 2 Group 2 will be given commercially available, cold pressed N.sativa (Black seed) oil and will be advised to apply it topically over the buccal mucosa (1 ml) thrice a day along with physiotherapy using ice cream sticks three times a day for the duration of 10 minutes (3-5minutes on each side). | Dietary Supplement: Group 2 Using N.sativa oil as an alternative to conventional management will help us to find a treatment option which is non-invasive, cost effective, inexpensive, easy available and belongs to a natural source with almost no side effects. |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - Patients with the age of 18 years and above - Patients clinically diagnosed with Oral submucous fibrosis - Patients who have not received any treatment for Oral submucous fibrosis in the last three months. - Patients who are willing to quit the habit of eating pan, gutka and areca nut - Patients who are willing to attend the follow up visits Exclusion Criteria: - Patients who are less than 18 years of age - Patients who are already using pain medications, corticosteroids or immunosuppressive drugs in any other form - Patients with a history of malignancy - Patients presenting with oral lesions other than Oral submucous fibrosis (OSMF) - Patients who are allergic to the drug material used in the clinical trial - Patients who will not give consent |
Wynik
Podstawowe miary wyników
1. Pain assessed using visual analogue scale (VAS) [6 months]
2. Inter-incisal mouth opening (IMO) assessed using vernier caliper [6 months]
Miary wyników wtórnych
1. Cheek Flexibility assessed following the method of Mathur and Jha (1993) [6 months]
2. Tongue protrusion [6 months]
