CTRI/2017/08/009200已完成2 期
CLINICAL EVALUATION OF NAVAYASA CHURNA IN THE MANAGEMENT OF IRON DEFICIENCY ANAEMIA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
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 between 18 to 50 years.
- •2) Patients with iron deficiency anaemia (Hb 8gm-10gm. %),
- •3) S. Ferritin < 30 μg /L
- •4) Patients with peripheral blood smear suggestive of Iron deficiency Anaemia
- •5) Willing and able to participate for 120 days.
排除标准
- •1. Patients suffering from Thalassemia major / Aplastic anaemia / Sickle cell anaemia.
- •2. Patients with evidence of malignancy.
- •3. Stool examination found with positive ova/cyst/parasite of worm infestation.
- •4. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, Bleeding disorders, etc.)
- •5. Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •6. Symptomatic patient with clinical evidence of Heart failure.
- •7. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
- •8. Patients suffering from Diabetes Mellitus (F.B.S. > 250 mg/dl.)
- •9. 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.
- •10. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino
- •Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (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 Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]).
- •11. Alcoholics and/or drug abusers.
- •12. Pregnant / lactating woman
- •13. H/o hypersensitivity to the trial drug or any of its ingredients.
- •14. Patients who have completed participation in any other clinical trial during the past six (06) months.
- •15. Any other condition which the Investigator thinks may jeopardize the study.
研究者
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