CTRI/2022/06/043097已完成3 期
Evaluation of efficacy and tolerability of select Ayurveda formulations in moderate Iron Deficiency Anemia – A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- Change in hemoglobin level as compare to standard of care.
研究概览
简要总结
| Anemia is the most common hematological disorder and is one of the most common conditions seen in clinical practice. Iron deficiency anemia is the most common cause of anemia. Most the anemia are easy to treat and thereby improve a person’s productivity. Anemia management can range from simple to complex based on the underlying condition causing it. The most common reason for non-compliance with Iron therapy was found to be “forgetfulness†(63.0%) followed by “side effects†(49.5%) in a study. However another study showed that the leading reported reasons for non-adherence were side effects (63.3%). The present study will explore the effect of the combination of two classical Ayurveda formulations viz., Mandur Vatak and Drakshavaleha on the level of hemoglobin in patients with moderate anemia without exhibiting side effects as compared to the standard of care. If found effective (non-inferior), it could be the first study to document the efficacy and safety of said formulations scientifically. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •i.Participants of age between 18 to 55 years of any sex.
- •ii.Hemoglobin ranging between 8 to 10.9 gm/dl iii.Hematocrit less than 41% in men and less than 36% in women iv.Mean corpuscular volume less than 80% v.Willing to provide informed written consent for participation in the study.
排除标准
- •i.Recent history of severe acute or chronic blood loss from the gastro intestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, surgery, trauma, etc.
- •ii.Participants suffering from megaloblastic anemia (pernicious anemia) (Serum Vit.
- •B12<150 pg/ml) or Hypothyroidism (TSH>10 mIU/L) iii.Patients already on iron supplements at present or during the last 3 months iv.Known case of disease conditions with intestinal malabsorption, alcohol use disorder (AUD) (CAGE score >2), anaemia due to chronic disease and medications, Thalassemia, Sideroblastic anemia, sickle cell, cold hemoglobinuria (Donath-Landsteiner hemolytic anemia), cold agglutinin disease (cold antibody hemolytic anemia), and other hemolytic anemias disseminated intravascular coagulation (DIC), Bone marrow suppression (aplastic anemia and myelophthisic anemia), Myelodysplastic syndromes, mechanical heart valves, hemolytic uremic syndrome (HUS), etc.
- •Known case of other major co-morbidities like chronic cardiac/ pulmonary diseases, malignancy, etc.
- •vi.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
- •creatinine > 1.2mg/dl) vii.Patients on prolonged (> 6 weeks) medication (steroids, immune-suppressants, disease modifying agents, chemotherapy etc.) for any chronic disease that may have an influence on the outcome of the study viii.
- •Pregnant women or women who are planning for conception or lactating mothers.
结局指标
主要结局
Change in hemoglobin level as compare to standard of care.
时间窗: at baseline, and at the end of 12th week
次要结局
- i.Proportion of participants achieving a hemoglobin increase of ≥2 g dL(ii. Change in a score of FACIT –Fatigue scale disease-specific symptoms ])
研究者
研究点 (5)
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