CTRI/2022/09/045556招募中不适用
A Single Centeric Randomized Double Arm-Parallel, Open-label, Interventional, after administration of Tri-Fer and comparator, the subjects were observed for 3-months of treatment duration of establishment Mild hormonal imbalance related iron deficiency
Stockshift India Pvt Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome will be hemoglobin-levels improvements, measured before and after 3
研究概览
简要总结
A Multicentric, Randomized, Double Arm-Parallel, Open-label, Interventional for established Mild Hormonal imbalance related iron deficiency, after administration of IP and Comparator. A total of 50 subjects aged between 18-50 years with Mild-moderate iron deficient anemia due to Mild Hormonal imbalance participated in this study.
Subjects with Mild-moderate iron deficient anemia due to Mild hormonal imbalance is allocated and provided to receive Tri-Fer fixed Dose capsules Bid for 6 months and take 1 capsule twice daily for period of 180 Days but assessment is conducted on 3 months ( 90 days ) on 3 visits during treatment duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects who meet the following criteria shall be considered eligible to participate in the study: 1.Subjects of age group between 18-50 years of women’s are included in the study.
- •2.Female population.
- •3.A diagnostic of mild-moderate iron deficient anemia due to Mild Hormonal imbalance.
- •4.Already established Mild Hormonal imbalance (Tri-Fer as therapy).
- •5.Subjects who are willing to give informed consent without any hindrance are included in the study.
排除标准
- •Subjects below 18 years and above 60 years of age are excluded from the study.
- •Patients with anemia caused by conditions other than iron deficiency.
- •Patients with abnormal laboratory test values at screening.
- •Patients with liver, kidney or circulatory system disease.
- •Patients with a history or present illness that is a malignant tumor or autoimmune disease.
- •Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening.
- •Patients who underwent oral administration of an iron preparation (including an over-the counter drug or supplement) within 4 weeks before the screening.
- •Severe anemia or Hormonal imbalance.
- •Patients who are undergoing or undergone Hormonal therapy in last one year.
- •PregnancyShift T R A N S F E R I N G V A L U E Page 24
- •Subjects with gastro or duodenal ulcers and are also afflicted with dysphagia & odynophagia are excluded from the study.
- •Subjects with persistent GI bleeding and frequent vomiting are excluded from the study.
结局指标
主要结局
The primary outcome will be hemoglobin-levels improvements, measured before and after 3
时间窗: 3month, 6 Month
months of Therapy of Tri-Fer Against the iron sulphate
时间窗: 3month, 6 Month
次要结局
- To assess the hormonal imbalance improvement in the treatment period.(• To assess the hormonal imbalance under observation by hormonal questionnaire.)
研究者
研究点 (1)
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