Chewable cough tablets with improved palatability: A comparative phase II clinical trial

Abstract

Cough is the common disease condition which affects patients of every age. Numerous OTC medications available in community pharmacies however no antiviral treatment and even antibiotics has been shown to be effective without pre-existing lung infection. The treatment approach of medicinal herbs has been recognized for many decades and even longer for the treatment and prevention of cough. The aim of this study was to evaluate the safety and efficacy of Mukalbion poly herbal chewable tablets for the treatment of cough with improved palatability against a marketed brand (Poly herbal). For the formulation development of test group, the herbs were supplied by the Procurement department of Herbion Pakistan Pvt. Ltd. Althea officinalis (roots), Hedera helix (leaves) and Sisymbrium irio (seeds) were used for the manufacturing of Mukalbion (poly herbal, test group) chewable tablet. The comparative control clinical trial was carried out during a time frame of 07 months with sample size of 70 patients as per epidemiological software for sample size and each group contained 35 (±5) patients. Chewable tablets were administered and evaluated for effectiveness after 15 days of treatment. The data were collected by the patients through clinical trial questionnaire. The validated quality of life questionnaire (LCQ) was also used for assessment. The results were analyzed by applying paired sample T test by using IBM SPSS version 20.00. The p value was ≤0.005 at 95% confidence interval for cough variables including cough bouts, viscosity of sputum, chest congestion, sore throat and shortness of breath. The LCQ cough scale score was higher in test group as compared to control group. The test group also showed well tolerated in term of palatability. None of the patient claimed any of the side effects and no compliance were observed against the marketed brand.