Evaluation of efficacy and tolerability of Abhraloha tablets in iron deficiency anaemia – Phase IV study

Anemia is a condition in which number of RBC becomes insufficient consequently decreased ability of blood to carry oxygen to meet physiological needs of cell. The World Health Organization (WHO) describes iron-deficiency anemia as "the most common and widespread nutritional deficiency in the world." Prevalence of Anaemia is increasing in India and assessing the severity of the problem, it has been even included in the thrust area of health sectors governed by WHO and Ministry of AYUSH, Govt of India. Haemoglobin concentration lower than 12g/dL in women and 13g/dL in men is considered as Anemia.  Prevalence of anemia is more in women and children. About 30 % world populations are anemic All over India, 70% population are anemic. In Gujarat and Vadodara, prevalence rate is 55.3% and 49.2% respectively. 

This study is a multi-centric, prospective, Phase IV trial to evaluate the efficacy and tolerability of Abhraloha in Iron Deficiency Anemia. Abhraloha in the dose of 2 tablets twice times a day with lukewarm water after food for 2 months. Total duration of study is 12 months. There will be total 5 follow-ups during study which will be scheduled on every 15+-5 days.

Study End Points are:Primary end point : Mean change in Hb % and Secondary end point: Safety assessed by incidence of adverse events and any abnormal laboratory parameters during the study duration.