跳至主要内容
临床试验/CTRI/2024/11/077400
CTRI/2024/11/077400已完成Unknown

A pilot study to evaluate the efficacy of Bjain Omeo Anemia Syrup in patients with Anemia

BJAIN PHARMACEUTICALS Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年12月9日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
6
试验地点
1
主要终点
1, % Change in Hemoglobin

研究概览

简要总结

Test Product: Bjain Omeo Syrup

Route of Duration: Syrup orally twice a day

Test Druartion: 60days

Objective is to study the efficacy :

• Change in Haemoglobin, • Change in Iron levels

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects of either gender- male or female of age 18-
  • 2.Healthy subjects with reported diet deficient Anemia of any grade.
  • Mild: Hemoglobin 10.0 g/dL to lower limit of normal. Moderate: Hemoglobin 8.0 to 10.0 g/dL. Severe: Hemoglobin 6.5 to 7.9 g/dL
  • Having signed a Consent Form. 4.Should be able to read and write (in English, Hindi or local language).
  • Having valid proof of identity and age.

排除标准

  • Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
  • Having refused to give her assent by not signing the consent form
  • Taking part in another study liable to interfere with this study
  • Anemia related to any known Chronic disease
  • Having cutaneous hypersensitivity
  • Following a chronic or intermittent medicinal treatment comprising any of the following products: aspirin-based products, antiinflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
  • Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

结局指标

主要结局

1, % Change in Hemoglobin

时间窗: Day 0, Day 30, day 60

2. % Change in Serum Iron

时间窗: Day 0, Day 30, day 60

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
BJAIN PHARMACEUTICALS Pvt. Ltd.
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Poornima Kaushal

CCFT Laboratories

研究点 (1)

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