A Clinical Study to Evaluate the Efficacy and Safety of Polyherbal Unani formulations in the management of IltihÄb TajÄwÄ«f- al-Anf Muzmin (Chronic Rhinosinusitis)

IltihÄb TajÄwÄ«f -al-Anf (Sinusitis) is the mucosal inflammation of the paranasal sinuses1. However, as this condition is invariably associated with inflammation of the nasal mucosa. Hence, nowadays the term Rhinosinusitis (RS) has been preferred. Rhinosinusitis is of two types - acute and chronic. Chronic rhinosinusitis is chronic inflammatory disease of nasal and paranasal sinus mucosa where symptomatology has continued beyond 12 weeks . Rhinosinusitis affects a tremendous proportion of the population, accounts for millions of visits to primary care physicians each year and is the fifth leading diagnosis for which antibiotics are prescribed . Chronic inflammation of the sinus mucosa is a common disease. Chronic rhinosinusitis is usually the result of incompletely resolved acute rhinosinusitis . The maxillary sinus is the most commonly involved paranasal sinus in chronic rhinosinusitis. However, the inflammation of the other sinuses is not uncommon and sometimes all the sinuses are involved, resulting in pansinusitis. Chronic rhinosinusitis affects approximately 5–15% of the general population. The national institute of allergy and infectious disease (NIAID) estimated that about 134 million Indians suffered from chronic rhinosinusitis. The symptoms of chronic rhinosinusitis are not life threatening but they are associated with the reduction in quality of life7. Rhinosinusitis typically causes a combination of nasal congestion, nasal blockage, nasal discharge and may be accompanied by facial pain or pressure and loss of smell (anosmia). Pain is aggravated on stooping or coughing . Complications of chronic rhinosinusitis are deafness, tinnitus,osteomyelitis, orbital abscess, orbital cellulitis, meningitis, brain abscess, subdural abscess, extradural abscess, cavernous sinus thrombosis, acute suppurative otitis media, chronic suppurative otitis media, pharyngitis, tonsillitis, persistent laryngitis and tracheobronchitis. Medical management of chronic rhinosinusitis often requires multiple medications including antibiotics, antihistamines, nasal decongestants, topical or oral steroids and saline irrigation. Antibiotics causes several side effects such as Cushing syndrome, abdominal tenderness, bloating, cramps, diarrhoea, epistaxis, haematuria etc. Antihistaminic side effects are mydriasis, sedation, dry eyes, dry mouth, constipation, and urinary retention. Significant overdose of antihistamines can cause serious toxicity and even death. Levocetirizines leads to mild sedation, somnolence, dry mouth and in some patient hepatotoxicity noticed . Fexofenadine is not safe in patient with long QT interval, bradycardia and hypokalemia. Nasal decongestants like oxymetazoline and xylometazoline cannot give for more than 5 days because of the potential for rebound congestion and rhinitis medica mentosa . Patient who does not respond to medical treatment requires surgical treatment (Caldwell-Luc operation). There is no solution for permanent relief and need an alternative approach which is effective and safe. There are many single as well as compound Unani drugs which are effective in chronic rhinosinusitis but many of them have not been evaluated clinically on scientific parameters. The limitation of management of chronic rhinosinusitis available in modern medicine necessitate a scientific search for effective, safe and convenient medication for the disease. Keeping this in view, the present study is designed to evaluate the efficacy and safety of polyherbal Unaniformulations in the form of JoshÄnda (decoction) of Asl-al-SÅ«s, Barg-i-GÄozabÄnand along with InkibÄb (steam Inhalation) of Sabus Gandum (wheat husk) and SirkÄ (vinegar) in case of chronic rhinosinusitis10,15,16,17,18. Pharmacological action of these Unani formulations are anti-inflammatory, analgesics, neurotronic and nasal decongestant