Clinical study on Abhraloha in iron deficiency Anemia
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2019/01/017303
- Lead Sponsor
- Shree Dhootapapeshwar Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 57
1.Women >18 years to <65 years old.
2.Women diagnosed with iron deficiency anemia (criteria stated in Annexure 1) and Hb<=10 g/dL and >7gm/dl and serum ferritin <30ug/L
3.Women in postpartum period 10 days after delivery
4.Women with negative urine pregnancy test.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method