Comparison of Unani formulations Zuroor-e-Qula and Jawarish Amla sada with allopathic antioxidants in management of patients with early-intermediate stage oral submucous fibrosis

Oralsubmucous ï¬brosis (OSMF) is a chronic, insidious disease that is associatedwith signiï¬cant functional morbidity and an increased risk for malignancy. Itprimarily occurs due to areca nut chewing and is characterized by restrictedmouth opening, burning sensation on having hot and spicy food and stiffness andblanching of the oral mucosa. OSMF predominantly affects South Asian and East Asian populations. OSMF isthe major health issue affecting 14 million Indian population. Themalignant transformation rate of OSMF in India has been reported to as high as27% over many years.

Treatmentof OSMF is a challenge. A wide range of treatment including drug management,surgical therapy, and physiotherapy have been attempted till date, with varyingdegrees of benefit, but none have been able to cure this disease. Severalcomplementary and alternative medicines have been evaluated in OSMF patientslike curcumin, aloe vera, spirullina, allicin  andpapain. Anti-oxidants like lycopene obtained from tomato extract andherbal anti-oxidants like oxitard are found to be effective in the managementof OSMF.

Theclassical literature of Unani System of Medicine has a large number offormulations which have been used in various diseases of oral cavity. All theimportant books such as KitÄb al-HÄw**Ä« fi’l-Tibb byMuhammad b. Zakariyya RÄzÄ« (d. 926),al-Mu‘ÄlajÄt al-BuqrÄtiyya byAbÅ« HasanAhmad b. Muhammad TabarÄ«(d. 985), KÄmil al-SanÄ‘a al-Tibbiyyaby ‘AlÄ« b. ‘AbbÄs MajÅ«sÄ« (d. 994),Ghin**Ä MunÄby AbÅ« MansÅ«r Hasan QamrÄ« (d. 999)*,al-QÄnÅ«*n fi’l-Tibb byIbn SÄ«nÄ (d. 1037), al-MÅ«jaz fi’l-Tibbby Ibn NafÄ«s QarshÄ« (d. 1288), KitÄb al-TaysÄ«r fi’l-MadÄwa wa-al-Tadb**Ä«**rby Ibn Zuhr (d.1162), KitÄbal-MukhtÄrÄt fi’l-Tibbby Ibn Hubal (d. 1213), Sharahal-Asb**Äb wa-al-‘AlÄmÄt by NafÄ«s b. ‘Iwaz (d. 1439),  MÄ«zÄnal-Tibb by Akbar ArzÄnÄ« (d. 1721), Iks**Ä«r-i A‘zam byMuhammad A‘zam KhÄn (d. 1902) have exclusive chapters on thediseases of oral cavity.

Formulationsmentioned in different formularies and pharmacopoeias of Unani System ofMedicine have never been tried in OSMF patients. The formulationsdiscussed/mentioned under the heading of Qulđ(Stomatitis)have many ingredients which may be useful in OSMF patients. Secondly, theantioxidants have been found to be beneficial in the cases of OSMF and variousstudies have reported the benefits of these agents in OSMF. Many single andcompound drugs mentioned in the Unani classics have many ingredients which havebeen shown to possess antioxidant activity and may be useful in OSMF. The individual constituents of the presentformulations have also been reported to be safe (18). The current studystems from lacunae in the routine usage of unani formulations for thisdebilitating oral disorder. Therefore, it was hypothesized that unaniformulations could be effective in patients with OSMF due to theiranti-inflammatory, potent anti-oxidant and anti-carcinogenic properties. Inthis 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 intermediatestage OSMF.