A Single-Site, Single-Arm, Prospective Clinical Study to Assess the Role of BJain’s Omeo Anemia Syrup in Cases of Nutritional Anemia in Females of Reproductive Age Group.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in hemoglobin levels.
研究概览
简要总结
This clinical study aims to evaluate the effectiveness and safety of BJain’s Omeo Anemia Syrup in improving hemoglobin levels and reducing fatigue in women of reproductive age (18–45 years) with nutritional anemia. Nutritional anemia, primarily caused by iron, folic acid, and vitamin B12 deficiencies, remains a significant public health challenge, affecting approximately 57% of Indian women (NFHS-5, 2019-21).
This single-site, single-arm, prospective study will be conducted over five months at a designated research site. Participants will receive BJain’s Omeo Anemia Syrup (10 mL, twice daily) for three months, with hemoglobin levels and fatigue scores (using the Fatigue Severity Scale) measured at baseline and follow-up visits.
The study aims to assess changes in hemoglobin levels as the primary outcome, with fatigue reduction as a secondary outcome. This research seeks to provide scientific evidence supporting homeopathic interventions for nutritional anemia, offering a potentially well-tolerated alternative to conventional iron supplements.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Diagnosed with nutritional anemia with Hb less than 12 g/dL.
- •Willing to provide informed consent and comply with the study protocol.
排除标准
- •Pregnant or breastfeeding women.
- •Chronic conditions affecting hemoglobin e.g., thalassemia.
- •Known allergy to the investigational product.
- •Any past surgeries in 6 months.
结局指标
主要结局
Change in hemoglobin levels.
时间窗: It will be assessed at 1 month, 2nd month and 3rd month at each follow up.
次要结局
- Change in fatigue scores using the Fatigue Severity Scale (FSS).(Participants will be assessed at baseline, at 2 months, at the end of the 3-months study period.)
研究者
Dr Kiran
BJain Pharmaceuticals Pvt. Ltd.