A preliminary study on the efficacy and safety of Polyherbal Unani formulation in the management of mild to moderate COPD subject with Chronic bronchitis: An open-label clinical study

Chronic bronchitis (CB) is a common but variable phenomenon in COPD. It is occurring worldwide and public health problem over 40 years of age and will remain a challenge for the future. It is a significant cause of chronic morbidity and mortality worldwide. The primary objective of the study was to evaluate the efficacy and safety of Polyherbal Unani formulation in the management of mild to moderate COPD subjects with CB. It was an open-label clinical study conducted on 50 participants. Polyherbal Unani formulation has been given orally with lukewarm water twice a day for three months. It was assessed based on subjective and objective parameters. The subjective parameters were assessed by BCSS (Breathlessness Cough Sputum Scale) and objective parameters by FEV1 and FEV1/FVC. It was observed that the difference between the mean value of BCSS score, p-value came out to be at the end of the study in comparison to baseline were highly significant (p<0.0001), while in FEV1 and FEV1/FVC, p-value came out to be <0.05 respectively which shows significantly increased in FEV1 and FEV1/FVC. The preliminary finding indicate that potential therapeutic role of polyherbal unani formulation in the treatment of Chronic bronchitis. The test drug is cost-effective and safe because of the devoid of any observable side effects.