Effect of supplementation of Amla (Emblica officinalis) in Honey on the hematological profile and iron homeostasis in anemic pregnancy: An open -labelled clinical trial.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
RESEARCH QUESTION
Does supplementation of Amla (Emblica officianalis) in anemic pregnant women improve their hematological profile and iron homeostasis
AIM
To assess the effect of supplementation of Amla (Emblica officianalis) in honey in anemic pregnant women on their hematological profile and indices of iron homeostasis
OBJECTIVES
PRIMARY
(1) Estimations of the hematological profile and indices of iron homeostasis before and after supplementation of Amla (Emblica officianalis) in a group of anemic pregnant women for a period of 45 days in addition to their regular iron supplementation.
(2) Estimations of the hematological profile and indices of iron homeostasis before and after 45 days of regular oral iron supplementation in another group of anemic pregnant women.
(3) Comparison of the changes in the hematological profile and iron homeostasis between the two groups after the 45 days of study
SECONDARY
(1) Assessment of the quality of life in anemic pregnant women in general and in relation to gastro intestinal disturbances, nausea and vomiting using standard questionnaires with and without Amla supplementation.
(2) Correlation analyses among indices of iron homeostasis, oxidative stress and inflammation.
METHODOLOGY
After the successful registration in CTRI Pregnant women with mild iron deficiency anemia on oral iron therapy visiting the Obstetrics and Gynecology department antenatal out patient clinic meeting the inclusion and exclusion criteria will be recruited as the participants of the study
They will be divided into two groups by block randomization with stratification by convenient sampling method
Control group will be supplemented with usual oral iron therapy (60mg elemental iron three times a day) along with life style modifications which is advised by their treating doctor
Interventional group will be provided supplementation of two amla in honey (one in the morning and one in the night) every day for 45 days along with usual oral iron therapy (60mg elemental iron three times a day) and life style modifications which is advised by their treating doctor
The investigations including serum hepcidin, oxidative stress, serum ferritin and soluble transferrin receptor and hsCRP levels and hematological profile will be assayed before and after intervention along with their quality of life
The data will be statistically analysed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Hemoglobin level between 9 to 11 milligram per deciliter Age between 18 to 35 years 1st and 2nd trimester of pregnancy On oral iron therapy.
排除标准
- •Patients with a history of anemia due to any other conditions like bleeding piles cardiac or renal or liver disorders Diabetes Mellitus Hypertension Pregnancy induced complications like hyperemesis gravidarum antepartum hemorrhage pre eclampsia eclampsia GDM jaundice Patients with a history of drug abuse Patients with a history of allergy to amla or honey.
结局指标
主要结局
Hemoglobin level
时间窗: 45 days
Hematological profile
时间窗: 45 days
Indices of iron homeostasis
时间窗: 45 days
次要结局
- Quality of life(45 days)