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 (Unpublished data of CCRAS) The objective of the current study is to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.)