A single-arm clinical trial to evaluate the effect of Annabhedi Sindooram in the management of anemia with reference to hemoglobin percentage
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the change in Hb% over the study period at specific time points.
研究概览
简要总结
Anemia, characterized by a deficiency in red blood cells or hemoglobin, results in inadequate oxygen transport and manifests through symptoms such as fatigue, pallor, weakness, and shortness of breath. In the Ayurvedic context, this condition aligns with Pandu, where the function of Rasadhatvagni is significantly impaired. Various etiologies contribute to anemia, including nutritional deficiencies, chronic diseases, genetic disorders, and bone marrow pathologies. This study is designed as a single-arm clinical interventional trial, with an aim to evaluate the efficacy of Annabhedi Sindooram in improving hemoglobin levels in patients attending the OPD of Pankajakasthuri Ayurveda Medical College Hospital, specifically those with Hb% less than 11 gm/dl. The intervention involves administering Annabhedi Sindooram capsules at a dosage of 1-0-1 (A/F) with lime juice for 180 days. The primary outcome will focus on changes in hemoglobin levels, while secondary outcomes will encompass various subjective and objective measures of anemia, assessed at baseline and at defined intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Subjects with Hb% less than 11 gm/dl.
- •Age group between 18 and 60 years.
排除标准
- •Anemia secondary to disorders like liver cirrhosis, rheumatoid arthritis, uremia, or malignancies.
- •Sideroblastic anemia, thalassemia major or minor.
- •Iron deficiency anemia in pregnancy.
结局指标
主要结局
To evaluate the change in Hb% over the study period at specific time points.
时间窗: Baseline (0th Day): Initial Hb% measurement before the start of treatment. | 90th Day: Intermediate Hb% measurement to assess ongoing response. | 180th Day (End of Study): Final Hb% measurement to determine the overall effectiveness of the treatment.
次要结局
- Objective Parameters (CBC, Serum Ferritin, Reticulocyte Count)(Subjective Parameters (Fatigue, QoL, Symptom Assessment))
研究者
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation
