CTRI/2018/08/015146尚未招募4 期
Clinical Evaluation of Drakshavaleha in the Management of Pandu (Iron Deficiency Anaemia). - DIIDA
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients of either sex aged between18 to 50 years.
- •2. IDA documented by hematologic indices.
- •i. Hb 8gm-10gm. %
- •ii. S.Ferritin < 12 ng /mL
- •iii. TIBC >450mcg/dL
- •iv. S.Iron <60μg/dL for male; <50 μg/dL for female
- •v. MCV <80fL/redcell
- •vi. RDW >46fL
- •vii. Reticulocyte count <0.5%
- •(Among these the first 3 are the essential criteria for inclusion)
- •3. Willing and able to participate for 112 days.
排除标准
- •1. Iron deficiency likely or definitely due to blood loss from the intestine or other sites.
- •2. History or evidence of intestinal malabsorption
- •3. Patients suffering from major systemic illness necessitating long term drug
- •treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, Bleeding
- •disorders, etc.)
- •4. Other causes of Anemia (sickle cell disease, thalassemia, other hemolyticAnemia,
- •bone marrow failure, etc.) apparent by history, physical examination, and/or
- •laboratory tests.
- •5. Patients on prolonged ( > 6 weeks) medication with corticosteroids,
- •antidepressants,anticholinergics, etc. or any other drugs that may have an influence
- •on the outcome of the study.
- •6. Patients with concurrent serious hepatic disorder (defined as Aspartate
- •AminoTransferase (AST) and / or Alanine Amino Transferase (ALT), Total
- •Bilirubin, AlkalinePhosphatase (ALP) > 2 times upper normal limit), or Renal
- •Disorders (defined as S. Creatinine >1.2mg/dL), Total Serum Cholesterol & / or
- •Serum Triglycerides > 250 mg/dl, Severe PulmonaryDysfunction (uncontrolled
- •Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease[COPD]).
- •7. Alcoholics and/or drug abusers
研究者
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