Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Abhraloha: Proprietary medicine indicated in Pandu. It consists of Loha Bhasma, Abhraka Bhasma, Amalaki, Shatavari etc.Total duration of therapy is 2 months
Control Intervention1: Ferro
Sponsors
Shree Dhootapapeshwar Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women >18 years to 2. Women diagnosed with iron deficiency anemia (criteria stated in Annexure 1) and Hb7gm/dl and serum ferritin 3. Women in postpartum period 10 days after delivery 4. Women with negative urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Women with significant vaginal bleeding (estimated blood loss greater than 100 cc) in the 24 hours prior to randomization 2. Women with a history of anemia other than iron deficiency anemia or anemia due to blood loss due to delivery. 3. Women on current treatment with myelo suppressive therapy or asthma therapy 4. Women with recent blood transfusions, or erythropoietin within 3 months prior to screening. 5. Women with history of bleeding tendency, history of blood transfusion within the prior 120 days, hemoglobinopathy or other red cell disorders. 6. Women with serum transaminases, total protein and albumin >1.5 upper limit of normal 7. Women with serum creatinine >1.5 mg/dl 8. Women with known Intolerance to iron derivatives 9. Women with history of alcohol or drug abuse, bleeding disorder 10. Women having any severe active infectious disease requiring hospitalisation. 11. Women who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness. 12. Women with known history of positive screening result for hepatitis B and/or Hepatitis C virus. 13. Women with history of HIV or any immunodeficient conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ï?? To evaluate efficacy of Abhraloha in patients suffering from Iron deficiency anemia by assessing change in Haemoglobin level from baseline to the 8 week or at the final visit at the time of subject discontinuation.Timepoint: Day 0, Day 14, Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. serum ferritin, 2. Iron profile 3. red cell indices assessing change from baseline to final visit at the time of subject discontinuation visit. 4. improvement of signs of Pandurog assessed according to Ayurveda 5. symptomatic improvement in patient using fatigue scale. 6. safety of drug on clinical and laboratory parameters.Timepoint: Day 0, Day 14, Day 28, Day 56 | — |
Countries
India
Contacts
Public ContactDrVishnu Bavane
D.Y.Patil school of Ayurveda,Nerul,Navi Mumbai
Outcome results
None listed