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临床试验/CTRI/2025/08/092420
CTRI/2025/08/092420尚未招募2 期

Anaemia redressal through Natural diet and Education - A prospective longitudinal trial

National institute of Naturopathy1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Haemoglobin levels

研究概览

简要总结

Anaemia remains a significant global and national public health concern, particularly affecting young children, adolescent girls, and women of reproductive age. In India, anaemia affects over half of all women in this group, primarily due to iron deficiency and poor dietary practices. Conventional iron supplementation often causes side effects and poor adherence. Natural, iron-rich foods like Moringa oleifera, curry leaves, and Hibiscus sabdariffa offer promising, bioavailable, and culturally acceptable alternatives. Combining these dietary interventions with structured health education may enhance adherence and provide sustainable improvements in anaemia and overall health. Objectives: To assess the short-term and long term impact of natural dietary supplements on haemoglobin levels and quality of life in women with anaemia.

Design: Prospective longitudinal trial, Setting: Community-based recruitment from local centres Sample Size: 100 women of reproductive age (15–49 years) with haemoglobin <12.0 g/dL Duration:1-month intervention, with follow-ups at 3 and 6 months Assessments: Conducted at baseline, end of intervention, and two follow-up points. Measures include: Biochemical markers (haemoglobin, CBC), Anthropometric measurements, Quality of life (SF-36), Menstrual pain (VAS), Vitality (Subjective Vitality Scale), Mental well-being (WEMWBS)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 49.00 Year(s)(—)
性别
Female

入选标准

  • 1.Women of reproductive age 15–49 years 2.Haemoglobin levels less than 12.0 g/dL
  • resident of the target study community for at least 6 months and willing to remain in the area during the intervention period.

排除标准

  • Individuals with severe or life-threatening anaemia requiring immediate medical intervention
  • Individuals currently on iron supplementation or multivitamin therapy in the last 4 weeks
  • Pregnant women
  • Individuals diagnosed with hemoglobinopathies such as thalassemia or sickle cell anemia • Known hypersensitivity or dietary restrictions related to the food items being studied (Moringa, curry leaf, Hibiscus).

结局指标

主要结局

Haemoglobin levels

时间窗: Baseline (Day 0 – Pre-intervention | 2. End of Intervention (1 Month) | 3. Follow-Up 1 (3 Months Post-Baseline): All assessment | 4. Follow-Up 2 (6 Months Post-Baseline)

次要结局

  • Quality of Life (QoL)(Menstrual Pain Intensity)

研究者

发起方
National institute of Naturopathy
申办方类型
Other [Autonomous body]
责任方
Principal Investigator
主要研究者

Nivethitha L

National Institute of Naturopathy. Pune

研究点 (1)

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