A Randomized Parallel Group Open Label Active Controlled Clinical Study to evaluate the Safety and Efficacy of Unani Formulations Joshanda (Oral) and Takmid Muhallil (Local) compared with Levocetirizine in the Management of Waram Tajawif al- Anf Muzmin (Chronic Rhinosinusitis)

Chronic Rhinosinusitis (CRS) is a chronic inflammatory disease of the nasal and paranasal sinus mucosa persisting for more than 12 weeks. It is a common condition, affecting about 5–15 percent of the general population, with millions of cases reported annually in India. CRS is one of the leading causes of visits to primary care physicians and is among the top reasons for prescribing antibiotics. Although not life threatening, the condition significantly reduces quality of life due to persistent symptoms such as nasal obstruction, nasal discharge, facial pain or pressure, and loss of smell.

Maxillary sinus is most commonly involved, but pansinusitis may also occur. Complications include ear infections, orbital cellulitis, meningitis, brain abscess, and cavernous sinus thrombosis. Conventional medical management often involves prolonged use of antibiotics, antihistamines, nasal decongestants, steroids, and saline irrigation. These therapies are associated with adverse effects such as sedation, hepatotoxicity, rebound nasal congestion, and gastrointestinal disturbances. In non-responders, surgical procedures like Caldwell-Luc operation are used, but recurrence is common. Thus, there is no permanent cure, highlighting the need for alternative safe and effective options.

In Unani medicine, conditions resembling CRS are described under Nazla and Zukam. Classical Unani texts mention that chronic catarrhal discharges from the brain to nose and throat result in long-standing complaints. Management principles include hot fomentation (Takmid Har), steam inhalation (Inkibab), evacuation of morbid matter (Nuzj Mawad), removal of obstruction (Taftih Sudda), and strengthening of brain (Taqwiyat Dimagh).

Joshanda (oral decoction) and Takmid Muhallil (local hot fomentation) are compound Unani formulations recorded in Bayaz Kabir. They possess anti-inflammatory, antioxidant, antibacterial, antiallergic, analgesic, expectorant, and decongestant properties.

The present randomized, open label, parallel group, active controlled clinical Study has been planned to evaluate the safety and efficacy of these Unani formulations compared with Levocetirizine in the management of chronic rhinosinusitis. The study will assess improvement in symptoms, quality of life, radiological findings, and laboratory parameters to provide scientific validation of the Unani approach.