CTRI/2013/04/003528已完成4 期
A prospective, double blind random study to evaluate the efficacy and safety of ProGo powder to improve hemoglobin and sugar levels in elderly anaemic patients. - Nil
Spectrum Clinical Research Pvt Ltd0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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. Understand and voluntarily sign an informed consent form.
- •2. Age 50 years and older.
- •3. Able to adhere to the study visit schedule and other protocol requirements.
- •4. Women with Hemoglobin concentration >= 10 g/dL and < 12 g/dL and men with >= 11 g/dL and < 13 g/dL.
- •5. Situational anemia.
排除标准
- •1. Red blood cell transfusions within the past 3 months.
- •2. Estimated glomerular filtration rate (eGFR) of < 30 ml/min (by abbreviated MDRD).
- •3. Use of erythropoiesis stimulating agents (ESA) in the past 3 months.
- •4. Active infection defined as symptomatic, requiring active treatment (prophylaxis allowed) or hospitalized for > 24 hours primarily for infection within the past month.
- •5. Uncontrolled hypertension defined as diastolic blood pressure > 100 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions during screening period.
- •6. Other primary uncorrected cause for anemia including:
- •a. Known active inflammatory disease including autoimmune diseases (e.g., systemic lupus
- •erythematosis, rheumatoid arthritis, mixed connective tissue disease, sarcoidosis, bronchiolitis obliterans, vasculitis, polymyalgia rheumatica, temporal arteritis).
- •b. Chronic active infection (e.g., HIV, viral hepatitis).
- •c. Acute infection within past 3 months (pneumonia, sepsis, bacteremia, prostatitis).
- •d. Receipt of immunosuppressive therapy in the past 2 years.
- •e. Any cancer (aside from nonâ??melanoma skin cancer) in the past 2 years or on therapy for cancer.
- •7. Elevated AST or ALT >= 2x upper limit of normal.
- •8. Total bilirubin > 1.5 mg/dL.
- •9. Use of any other experimental drug or therapy within 28 days of initial screening visit.
- •10. Subjects expected to consume nonâ??steroidal anti inflammatory drugs (NSAIDs), corticosteroids,
- •methotrexate, furosemide or anticoagulants during the course of this study.
- •11. Elevated TSH, or other signs of hypothyroid condition.
- •12. History of cerebral vascular accident, a clinical diagnosis of angina or myocardial infarction, any coronary interventions (PCI, Bypass, Stent placement) within the prior 12 months to reduce the risk of subject requiring
- •aspirin therapy during the trial.
- •13. Dementia defined as the inability to independently provide informed consent.
- •14. Recent history of gastrointestinal bleed.
研究者
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