Multicentric Open Clinical trial on Dhatrilauha and Annabhedi chendooram in Iron deficiency Anemia

In conventional medicine, various forms of iron viz. Ferrous sulfate, ferrous fumerate etc. are commonly prescribed, but these therapies have their noted adverse effects e.g. nausea, vomitting, abdominal pain, diarrhoea /constipation. Owing to the gravity of the situation, a need for a safe /effective Ayurvedic & Siddha oral dosage forms to improve the haemoglobin level in iron deficiency anaemia was felt. Keeping the gravity of the situation and the public health needs in view, the council has initiated scientific studies on Dhatri Lauha and Annabhedi Chenduram, both promising formulations, and are being successfully prescribed by Ayurvedic and Siddha physicians without any side effects since centuries. The formulations have been standardized after formulating SOPs besides safety / toxicity evaluation. The formulations are found safe and biological activity studies revealed significant haematenic effect. (Unpublished data of CCRAS) The objective of the current study is to assess clinical safety and efficacy through measurable objective parameters.

OBJECTIVES

1) Observe the effect of Dhatri lauha and Annabhedi chenduram on haematological parameters viz. Hb%, MCV, MCHC, TIBC, Serum iron content and Serum ferritin in Iron DeficiencyAnaemia subjects. 2) 2) Observe the clinical safety of Dhatri lauha & Annabhedi chenduram in Iron Deficiency Anaemia subjects. The preparatory arrangements are completed; trial manual is published, and training imparted to70 investigators teams from 20 CCRAS institutes The multicentric clinical trials are in progress at 18 institutes of CCRAS and one collaborating center (MGIMS, Wardha.)