A Randomized, Parallel Group, Open Label, Active Controlled Clinical Studyto Evaluate the Safety and Efficacy of a Herbomineral Unani FormulationItrifal Fauladi in the Management of Faqr al-Dam ( Anaemia)

According to WHO Anaemia is a condition in which the number of red cells or the haemoglobin concentration within them is lower than normal. It is recommended that anaemia should be considered to exist in adult whose haemoglobin levels are lower than 13gm/dl (men) or 12gm/dl (women).Around 30% of the world’s population is anaemic and half of these are believed to have Iron Deficiency Anaemia. Globally, it is estimated that 40% of all children aged 6–59 months, 37% of pregnant women and 30% of women 15–49 years of age are affected by anaemia. The conventional medicine has various side effects such as epigastric pain ,heartburn ,nausea ,vomiting, bloating staining of the teeth, metallic taste, colic, usually constipation and some times diarrhoea.  So we select a classical Unani formulation to evaluate the safety and efficacy of the formulation.

This Randomized, Active Controlled, Parallel Group, Open Label, Clinical Study is planned to evaluate the safety and efficacy of the herbomineral Unani formulation  Itrifal Fauladi in the management of  Faqr al-Dam .Participants fulfilling Inclusion and Exclusion criteria will receive either Test or Control drug as per Randomization. In Test drug participants will start with Itrifal Fauladi  7gm  daily for 12 weeks. In Control drug participants will start with Ferrous Sulphate 200 mg/ day once for 12 weeks. Baseline and last follow up laboratory investigation will be done. Duration of study is 84 days.