A study to evaluate the safety and effectiveness of Unani formulation Itrifal Muqawwi Dimagh compared with Fexofenadine in patients with chronic rhinosinusitis

INTERVENTION: Intervention1: Itrifal Muqawwi Dimagh: Dosage form Semisolid compound Route of administration Oral Dosage 10 g on an empty stomach with water once daily in the morning for 4 weeks 1 Amla Khushk 50 gm 2 Post Bahera 50 gm 3 Post Halela Zard 100 gm 4 Tukhm i Khashkhash Safaid 50 gm 5 Gul i Khatmi 50 gm 6 Gul Surkh 50 gm 7 Kishneez Khushk Dhaniya 450 gm 8 Maghz i Badam Shirin 50 gm 9 Ghee Clarified Butter 100 gm 10 Shakar Safaid Sugar 2.5 kg 11 Waraq i Nuqra Silver foil 5 gm Control Intervention1: Fexofenadine Hydrochloride: Dosage Form Tablet Dose One Tablet 120 mg OD Mode of Administration orally Duration 4 weeks Instructions Participants will be advised to take one tablet once daily orally with water at bedtime for 4 weeks Avoid taking the medicine with fruit juices such as grapefruit apple or orange juice Avoid taking antacids within 2 hours of taking this medicine CONDITION: Health Condition 1: J329‐ Chronic sinusitis, unspecified PRIMARY OUTCOME: 1 Change in Sino Nasal Outcome Test 22 SNOT 22 score as compared to baseline ; 2 Change in Visual Analogue Scale VAS score for disease severity as compared to baselineTimepoint: 1 Change in Sino Nasal Outcome Test 22 SNOT 22 score as compared to baseline ; 2 Change in Visual Analogue Scale VAS score for disease severity as compared to baseline SECONDARY OUTCOME: 1 Safety assessment by monitoring Adverse Events ; 2 Changes in laboratory parameters Haemogram LFTs KFTs and Urine Examination ; 3 Changes in radiological findings assessed by Xray PNS Waters view ; Timepoint: Adverse Events At 2 weeks and 4 weeks ; Lab investigations At baseline and 4 weeks ; Xray PNS At baseline and 4 weeks INCLUSION CRITERIA: The following Participants will be included in the study 1 Participants of any gender aged 18 to 60 years 2 Participants who fulfilled the following AAO HNS American Academy of Otolaryngology Head and Neck Surgery criteria Twelve weeks or longer of two or more of the following signs and symptoms a Mucopurulent Drainage anterior posterior or both b Nasal Obstruction congestion c Facial Pain Pressure Fullness or d Decreased or loss of Sense of Smell Hyposmia Anosmia AND Inflammation is documented by one or more of the following findings a Purulent not clear mucus or edema in the middle meatus or anterior ethmoid region b Polyps in nasal cavity or the middle meatus And or c Radiographic imaging showing inflammation of the paranasal sinuses 3 Ability to understand and give informed consent for participation 4 Wil