Pharmaceutical Analytical and Interventional study of Darvyadi Granules in Iron Deficiency Anaemia-A Pilot Study

Anaemia is a major public health concern in India and20% of the population suffer globally. The major cause of the disease isrecognized as Iron deficiency. In the present project objective of the study willbe to evaluate the efficacy of Darvyadi Granules in Iron deficiency anaemia inhuman subjects. In Panduroga Rogadhikaraof Charak Samhita, Darvyadi churna is mentioned which is indicated in YakritVikara and Panduroga. It includes 9 ingradients namely Triphala, Trikatu,Darvi, Vidanga and Lauha Bhasma. In the present work this formulation ismodified to Darvyadi Granules for better acceptability and palatability to thepatients. Darvyadi Granules will be prepared in the teaching Pharmacy, PIAR.Raw materials and final product quality assessment will be done in recognizedanalytical laboratories.

Itis an open labeled single centric clinical trial.As it isa pilot study, sample size of 30 subjects irrespective of race, gender,occupation, socio economic status will be considered. The subjective parameterssuch as Pallor,Shortnessof Breath, Fatigue, Palpitation, and Dizziness will be assessed. Hb%, Complete Blood Count, SerumFerritin, Total Iron Binding Capacityand PeripheralSmear of the patient will be investigated to observe the effect. Patients willbe screened for the study based on subjective parameters Hb% and MCV. Patientswill be on treatment with trial drug for a period of 3 months and observationwill be done on every 15th day. The duration of the project will be18 months which includes preparation of the medicine, screening of the patientsand treatment period of 90 days. The observations will be statisticallyanalyzed and documented.