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临床试验/CTRI/2019/08/020493
CTRI/2019/08/020493尚未招募1 期

An open labelled single arm clinical study of Raktamarisha Ghana vati in Garbhini Pandu.

Sane Guruji Arogya Kendra1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年2月9日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Efficiency of Raktamarisha as a Pathya in pregnancy.

研究概览

简要总结

The study is Open labelled single arm clinical study of RAKTAMARISHA GHANA VATI (an Anubhuta yoga) in Garbhini Pandu. Total 50 Patients will be selected by calculating prevalence rate for the study for duration of 2 months. Effect of Drug will be studied and conclusion will be drawn according to observations and results.

Nowadays anaemia is a very common in pregnancy and it’s a life threatening disease. During pregnancy it can cause Preterm Labour pains, Abruptio placentae, Intrauterine growth Restriction, Low birth weight Baby. In puerperium it causes PPH, sepsis, delayed in wound healing of episiotomy and LSCS surgical wound.

RAKTAMARISHA means AMARANTH is a highly nutritious vegetable also proven Nutraceuticals rich in Iron, folic acid, vit C, and other micronutrients. Raktamarish is Raktapittahara according to Bhavaprakash. So extract of this will be taken out by making Ghana and Vati will be prepared to make easy to take and will be helpful for the patients who don’t like to eat vegetables.

Line of treatment for Anemia is Iron supplements, Some patients shows intolerance , Nausea, Vommitting , Gastric Disturbance to Avoid this obstetrician advice RAKTAMARISHA means in Marathi  Laalmath as a Pathya dravya, so study will be conduct to see the efficacy and adverse effects or RAKTAMARISHA in Garbhini Pandu. Raktamarisha is a very cheap and easily available.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.Hb below 10% and above 7% 2.All Garbhini patients fulfilling diagnostic criteria of Pandu.
  • 3.Iron deficiency anaemia, microcytic Hypochromic anaemia, microcytic Normochromic Anemia.
  • 3.2nd and 3 rd trimester patients.

排除标准

  • 1.Multiple pregnancy.
  • 2.Bad Obstetrics history and precious pregnancy.
  • 3.Drug allergy.
  • 4.Haemoglobinopathies like thalassemia, sickle cell anemia, pernicious anemia etc Anemia associated with the haemorrhagic disorders.
  • 5.High risk pregnancy.
  • 6.Secondary anaemia.

结局指标

主要结局

Efficiency of Raktamarisha as a Pathya in pregnancy.

时间窗: 2 months

Effect of Raktamarisha Ghana vati (An anubhuta yoga) in Garbhini Pandu.

时间窗: 2 months

Healthy baby with Healthy mother.

时间窗: 2 months

次要结局

  • Literary review of Raktamarisha will b carried out.(Complications due to Anaemia will reduce.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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