“Clinical study for the evaluation of efficacy and safety of Unani formulation in the management of Cirrhosis of Liverâ€

The study entitled “Clinical study for the evaluation of efficacy and safety of Unani formulation in the management of Cirrhosis of Liver†is open label, single arm study will be carried out in department of Moalajat, Majeedia Unani Hospital, Jamia Hamdard, New Delhi. Diagnosed patients of cirrhosis of liver, who fit into the inclusion criteria, will be enrolled for the study. Test drugs which are selected for the study are safe and effective in liver diseases are mentioned in Unani literature. The test drugs will be prepared in the PG lab of department of Moalajat. Standardization and extraction of test drugs will be conducted in the department of Ilmul Advia, School of Unani Medical Education and Research, Jamia Hamdard. A written consent sheet will be provided to the patient in a language known to him/her before enrolment. Duration of the therapy will be three months with sample size of 30 patients and the follow up will be at baseline,15th ,30th,60th and 90th day. The Mizaj(temperament) of the patients will be assessed before treatment. The parameters for evaluation of efficacy and safety will be clinical sign and symptoms, MELD score, Child Pugh score, APRI score, biochemical parameters (CBC with ESR, LFT, KFT, B. Sugar, S. Electrolytes, S.GGT, HbA1C, HBsAg, AHCV, PT/INR and radiological parameters (USG and Fibroscan). The investigations will be done before the treatment, on 30th day and after completion of the treatment. At the end of the study the data thus generated will be statistically analyzed.