"An Open Labelled Active Controlled Randomized Clinical Study to Evaluate the Efficacy of Ethanolic Extract of Kokilaksha (Asteracantha longifolia Nees.) in the Management of Iron Deficiency Anemia"

2 billion people – over 30% of the world’s population – are anaemic, many due to iron deficiency. Iron deficiency is the most common and widespread nutritional disorder in the world. In India too, Nutritional iron deficiency is the commonest cause of anemia. It is the only nutrient deficiency which is significantly prevalent in Industrialized Countries and in resource-poor areas, which is frequently exacerbated by infectious diseases. Malaria, HIV/AIDS, hookworm infestation, schistosomiasis, and other infections such as tuberculosis are particularly important factors contributing to the high condition, constituting a public health condition of epidemic proportions affecting a large number of children and women in developing countries. Iron deficiency anemia reduce the work capacity of individuals and entire populations, bringing serious economic consequences and obstacles to national development. Overall, it is the most vulnerable, the poorest and the least educated that are disproportionately affected by iron deficiency, and it is they who stand to gain the most by its reduction. In Ayurveda classics we don’t get any direct reference of Iron deficiency anemia but on symptom analysis, we can try to corelate it with Pandu Roga because of the predominance of Panduta (pallor) in the whole body. A prominent diagnostic feature of Pandu Roga is the pallor on the skin which occurs due to the quantitative and qualitative deficiency of Rasa and Rakta Dhatu caused either in the form of deficiency of haemoglobin and/or red blood cells (RBCs). Considering Panduta (pallor) as the predominant sign, the disease is termed as Pandu Roga. The regular response of iron deficiency anemia to adequate amounts of iron is an important diagnostic and therapeutic feature. Oral administration of simple ferrous salts provides inexpensive and satisfactory therapy. But all allopathic iron preparations are gastric irritant and common side effects of oral iron include nausea, abdominal pain and either constipation or diarrhoea. Ferrous sulphate usually causes severe gastrointestinal side effects like gastritis, constipation/diarrhoea. Parenteral iron therapy may be required if iron cannot be absorbed from intestine and patient experiences intolerable gut symptoms. In Ayurved classics, thorough approach to the treatment of Pandu Roga has been described from Samhita Kala to Adhunika Kala. Various Shodhana and Shamana treatments are enumerated in all the classics and Samgraha Granthas. Various formulations advocated in Ayurved literature are being used successfully in the management of Pandu Roga as well as Iron Deficiency Anemia. Human studies on use of Extract of herbal drug in iron deficiency anemia are lacking. Animal Study have been done on ethanolic extract of Kokilaksha in iron deficiency anemia which yielded significant improvement in erythrocyte count, haemoglobin content, leukocytes count and haematocrit values etc. It is obvious from the foregone introduction that the available contemporary management of iron deficiency anemia, even though being cheap is not devoid of side effects. On the other hand, there are so many Ayurvedic formulations in clinical practice which are not used in routine clinical practices. Documented data of their therapeutic effects are necessary to be highlighted for the social benefits. Another fact to be considered as the main approach for treating anemia is iron supplementation without correcting the metabolism whereas according to Ayurved Pandu is a Pitta dominant Tridoshaja disorder with involvement of vitiation of Rasavaha Srotas. The symptoms of Rasavaha Srotas vitiation are similar to the symptoms of Kapha vitiation. Thus, to reverse the Samprapti (pathogenesis), such a formulation is needed which can counteract Pitta-Kapha and act at Srotas level and correct the metabolism thereby increasing iron absorption. Keeping this in mind for the present study, ethanolic extract of Kokilaksha and ferrous sulphate were selected for the clinical trials in the Iron Deficiency Anemia. Hence, it is planned to check the role of these drugs through an open labelled active controlled randomised clinical trial.