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临床试验/CTRI/2025/01/078969
CTRI/2025/01/078969尚未招募2/3 期

Effect of Sharbat Anar Sheerin versus Ferrous Ascorbate in iron deficiency anemia during pregnancy- A randomized controlled trial

National Institute of Unani Medicine1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年1月31日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
36
试验地点
1
主要终点
Improvement in Hb%, Peripheral smear and Hematocrit value

研究概览

简要总结

Iron deficiency anemia is the most common cause of anemia during pregnancy. (WHO) defines anemia in pregnancy as hemoglobin (Hb <11 g/dL), or hematocrit (Hct <33%), at any time during the pregnancy.1 Anemia affects 20% of pregnant women; with iron, folic acid, or combined deficiencies being the most common causes. Based on WHO’s statistics, prevalence of anemia in pregnancy accounts for about 14% in developed and 51%in developing countries; India contributes to 65-75% of the cases.2 Risk factors for iron deficiency anemia (IDA) among pregnant women include a diet lacking adequate iron consumption, obesity, increased parity, low socioeconomic status, low educational attainment, ethnic minority etc.Pregnancy-related factors that worsens preexisting anemia in Indian women include increased iron and nutritional needs, excessive blood loss during labor, infections during the prenatal and postnatal phases and rapid successive pregnancy.3 In pregnant women, IDA is associated with an increased risk of preterm labour, low neonatal weight and perinatal complications. Severe IDA is also associated with increased perinatal and maternal mortality due to lower tolerance to excessive blood loss during delivery and increased risk of infections. Iron deficiency may hinder defective myelination in infants, so that the resulting anemia produces long-lasting defects in mental development and performance that may further impair the child learning capacity. Therefore, every case of anemia should be treated in pregnancy.4Therapy for IDA includes dietary modification, oral iron supplementation, intravenous iron and blood transfusion. WHO suggests 30-60 mg per day iron supplementation for all pregnant women .1 The main issue with oral iron therapy is compliance due to associated gastrointestinal side effects like bloating, diarrhea , heartburn, nausea, constipation, and dark stools.5 Intramuscular iron should be avoided as it is painful, requires multiple injections, stains the buttock, and is associated with gluteal sarcoma .Parentral iron is expensive and is associated with serious adverse effects (SAEs), including anaphylaxis and infusion minor reactions.1,6 Thus, the necessity for an alternative medical system emerges to minimise IDA’s complications and recurrence while providing minimal adverse effects and most economical treatment. Unani system of medicine provides cost effective and easily available medications which are relatively free from side effects. Hence, A randomized standard controlled clinical study is contemplated to evaluate and validate the therapeutic effect of Sharbat Anar Sheerin 7,8*(Punica granatum* Linn) on scientific parameters in IDA during pregnancy.

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 40.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women in the age group of 18 to 40 years, having singleton pregnancy between 13 to 26 weeks of gestation with mild to moderate anemia (Hb 7-10.9g/dl) with or without symptoms of dyspnoea, oedema, weakness, anorexia and fatigue.

排除标准

  • Pregnant women with systemic illnesses e.g HTN (systolic BP ≥140mmHg and diastolic BP ≥90mmHg),DM (FBS≥95mg/dl),TD, multiple gestation and anemia due to other causes like hemolytic anemia and hemorrhagic anemia .

结局指标

主要结局

Improvement in Hb%, Peripheral smear and Hematocrit value

时间窗: baseline and 8 weeks

次要结局

  • No secondary outcome(Not Applicable)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Zoha Zaya

National Institute of Unani Medicine

研究点 (1)

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