Clinical Evaluation of Lohasava and Amalaki Churna in the management of Iron Deficiency Anemia (Pandu)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Change in Hemoglobin percentage
Study Overview
Brief Summary
The nearest correlationof Pandu Roga can be made with iron deficiency anemia (IDA) in Modernsystem of medicine. Iron deficiency anemia arises when the balance of ironintake, iron stores and the body’s loss of iron are insufficient to fullysupport production of erythrocytes. As the IDA is a very common prevalentdisease in the society and the side effects of oral modern ironpreparations are very common, therefore to get a better alternative, anAyurvedic herbomineral medicine, Lohasava and Amalaki Churna, was chosen for a clinical trial in patients suffering from IDA.
Lohasava is a fermentedformulation that contains lauha churna processed with some herbs as triphala,trikatu etc. Iron is absorbed more easily in its ferrous form and ferrous ironsare formed in the acid conditions of gastric contents. Hence the formulationslike Amalaki Churna helps to develop that media which can improve the ironabsorption at gastric level and also acts as a carminative which reduces themal- metabolism of food and body tissues. Amalaki is also known for itsrasayana karma.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •(i)Hb 8gm-10gm.% (ii)S.Ferritin <13 µg/L(female) or <30 µg/L(male) (iii)TIBC level >450mcg/dL (iv)S.Iron<60μg/dL for male;<50 for female (v)MCV level<80fL/red cell (vi)RDW >46fL (vii)Reticulocyte count <0.5% (Among these the first 3 are the essential criteria for inclusion)
- •Willing and able to participate for 112 days.
Exclusion Criteria
- •1.Iron deficiency likely or definitely due to blood loss from the intestine or other sites.
- •2.History or evidence of intestinal malabsorption 3.Major co-morbidity such as a serious chronic medical condition unrelated to iron deficiency apparent on history, physical examination or laboratory tests 4.Other causes of anemia (sickle cell disease, thalassemia,other hemolytic anemia, bone marrow failure, etc.) apparent by history, physical examination, and/or laboratory tests 5.Liver enzymes, AST/ALT > 2 x the upper limit;serum creatinine more than the upper limit.
- •6.Patients on prolonged (> 6 weeks) medication that may have an influence on the outcome of the study 7.Other medical or social factors at discretion of treating physician.
Outcomes
Primary Outcomes
Change in Hemoglobin percentage
Time Frame: Baseline, and 84th day
Secondary Outcomes
- Change in Serum ferritin level(Change in Serum iron level)