Oral submucous fibrosis (OSMF) is a chronic, insidious disease that is associated with significant functional morbidity and an increased risk for malignancy. It primarily occurs due to areca nut chewing and is characterized by restricted mouth opening, burning sensation on having hot and spicy food and stiffness and blanching of the oral mucosa. OSMF predominantly affects South Asian and East Asian populations. OSMF is the major health issue affecting 14 million Indian population. The malignant transformation rate of OSMF in India has been reported to as high as 27% over many years.

Treatment of OSMF is a challenge. A wide range of treatment including drug management, surgical therapy, and physiotherapy have been attempted till date, with varying degrees of benefit, but none have been able to cure this disease. Several complementary and alternative medicines have been evaluated in OSMF patients like curcumin, aloe vera, spirullina, allicin  and papain. Anti-oxidants like lycopene obtained from tomato extract and herbal anti-oxidants like oxitard are found to be effective in the management of OSMF.

The classical literature of Unani System of Medicine has a large number of formulations which have been used in various diseases of oral cavity. All the important books such as Kitāb al-HāwÄ« fi’l-Tibb by Muhammad b. Zakariyya RāzÄ« (d. 926),al-Mu‘ālajāt al-Buqrātiyya by AbÅ« Hasan Ahmad b. Muhammad TabarÄ« (d. 985), Kāmil al-Sanā‘a al-Tibbiyyaby ‘AlÄ« b. ‘Abbās MajÅ«sÄ« (d. 994),Ghinā Munāby AbÅ« MansÅ«r Hasan QamrÄ« (d. 999),al-QānÅ«n fi’l-Tibb by Ibn SÄ«nā (d. 1037), al-MÅ«jaz fi’l-Tibbby Ibn NafÄ«s QarshÄ« (d. 1288), Kitāb al-TaysÄ«r fi’l-Madāwa wa-al-TadbÄ«r by Ibn Zuhr (d. 1162), Kitāb al-Mukhtārāt fi’l-Tibbby Ibn Hubal (d. 1213), Sharah al-Asbāb wa-al-‘Alāmāt by NafÄ«s b. ‘Iwaz (d. 1439),  MÄ«zān al-Tibb by Akbar ArzānÄ« (d. 1721), IksÄ«r-i A‘zam by Muhammad A‘zam Khān (d. 1902) have exclusive chapters on the diseases of oral cavity.

Formulations mentioned in different formularies and pharmacopoeias of Unani System of Medicine have never been tried in OSMF patients. The formulations discussed/mentioned under the heading of Qulā‘(Stomatitis) have many ingredients which may be useful in OSMF patients. Secondly, the antioxidants have been found to be beneficial in the cases of OSMF and various studies have reported the benefits of these agents in OSMF. Many single and compound drugs mentioned in the Unani classics have many ingredients which have been shown to possess antioxidant activity and may be useful in OSMF. The individual constituents of the present formulations have also been reported to be safe (18). The current study stems from lacunae in the routine usage of unani formulations for this debilitating oral disorder. Therefore, it was hypothesized that unani formulations could be effective in patients with OSMF due to their anti-inflammatory, potent anti-oxidant and anti-carcinogenic properties. In this study, we propose to evaluate the efficacy and safety of Unani drugs Zuroor-e-Qula and Jawarish Amla sada in the management of early and intermediate stage OSMF.