A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, ACTIVE CONTROLLED, CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF HABB I KHABATH AL HADID COMPARED WITH FERROUS SULPHATE IN THE MANAGEMENT OF FAQR AL DAM (IRON DEFICIENCY ANAEMIA)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Haemoglobin level at 56th Day from baseline
研究概览
简要总结
Anaemia is condition in which the number of red blood cells or the hemoglobin concentration within them is lower than normal
The WHO recommondes that anaemia should be consider to exist in adults whose hemoglobin level are lower than 13 gm/dl in males and 12 gm /dl in females.The several iron containing medication are utilized in modern medicine but oral iron therapy is frequently associated with adverse effect particularly involving GI tract that is constipation diarrhea abdominal bloationg abdominal discomfort and detal staining.
Given the current context it is essential to assess effectiveness of Unani medicine in treating iron deficiency anaemia as they offer safe and cost effective alternative. for this purposed study Habb e Khabsul hadid has been selected.
The aim of the study to generate safety and efficacy data in the managment of iron deficiency anaemia based on modern scientific parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of any gender in the age group of 18-60 years Participants with Iron Deficiency Anaemia (IDA) defined for this study as moderate anaemia with Haemoglobin (Hb) levels between 8 g/dL and 10.9 g/dL and Serum Ferritin level less than 15 µg/L Participants having any of the following signs and symptoms.
- •Pallor of Skin and Mucous Membranes Easy Fatigability Reduced Work or Exercise Capacity Dyspnoea on Exertion Palpitations Ability to understand and give informed consent for participation.
- •Willing to come for follow up visit as per protocol requirement.
排除标准
- •Participants aged less than 18 year and more than 60 years of age.
- •Participants with Hemoglobin less than 8 g/dL and more than 10.9 g/dL Pregnant and Lactating Women Known Case Of Diabetes mellitus History of Acute Blood Loss Known Cases of Cardiovascular/ Hepatic/ Renal Disorders or chronic diseases requiring long-term treatment Known Hypersensitivity to the study drug or any of its ingredients.
结局指标
主要结局
Change in Haemoglobin level at 56th Day from baseline
时间窗: 2nd and 4th week
次要结局
- Change in Serum Ferritin level at 56th day from baseline(Changes in Hematological Parameters (RBC,MCV,MCH,MCHC)at 56th day from baseline)
研究者
Dr Shaikh Reshma Bano Mohammad Haneef
National Research Institute of Unani Medicine for Skin Disorders