“A prospective community based study for the evaluation of Dhatri Lauha in Anemia (Pandu)â€
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 14
- 主要终点
- i.Mean Change in hemoglobin percentage from baseline.
研究概览
简要总结
Objectives
· Primary objective- To examine the role of Ayurvedic formulation Dhatri Lauha in Anaemia (Pandu)
· Secondary objective-
i) To assess the change in disease specific symptoms.
ii) To evaluate the tolerability of Ayurvedic formulation Dhatri Lauha.
1. Study Design : Interventional
2. Sample Size: 490 ( i.e. 35 each centre)
3. Duration of Study : 10 Month
4. Interventions : Dhatri Lauha ( Anupan : Honey)
5. Study initiated on -13th July 2021
6. Study Completed on -31st March 2022
7. Number of Cases Enrolled- 490
8. Number of cases Completed- 478
9. Number of Drop outs- 12
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •i.Participants of scheduled Tribe community of any gender in the age group 18 to 55 years. ii.Hemoglobin index (Hb gm %} ranging ≥8gm.
- •â‰¤10gm.%) iii.Willing to provide informed written consent.
排除标准
- •i.Recent history of blood loss from the gastro intestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, etc.
- •ii.History or evidence of intestinal mal-absorption iii.History of Major co-morbidity/ serious chronic Renal/ Hepatic/ cardiac/ pulmonary diseases etc.
- •Known / diagnosed case of any other type of anaemia (sickle cell disease, thalassemia, other hemolytic anemia, bone marrow failure, etc).
- •[apparent by history, physical examination, and/or laboratory tests if required.] v.Patients on prolonged (> 6 weeks) medication for any chronic disease that may have an influence on the outcome of the study vi.Patient with diagnosis/ known history of Myelodysplastic syndromes, cancer etc.
- •vii.Pregnant women/ women who are planning for conception/lactating women viii.Patients already on iron supplements at present or during the last 3 months ix.Any current medical condition, which the investigator considers would put the subject at unacceptable risk or affect study compliance.
结局指标
主要结局
i.Mean Change in hemoglobin percentage from baseline.
时间窗: Time frame: at baseline, 4th, 8th, 12th week and end of the 16th week
次要结局
- i.Assessment of changes in disease specific symptoms.(ii.Tolerability assessed by proportion of recruited participants remaining in the trial intervention.)