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临床试验/CTRI/2024/10/075582
CTRI/2024/10/075582尚未招募2/3 期

Randomized controlled clinical trial to evaluate the efficacy of Gudadi mandur in the management of garbhini pandu (iron deficiency anemia in pregnancy)

C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 4310011 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年11月4日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
Hb % will increase

研究概览

简要总结

Women are roota of progeny. Anemia is most commonest haematological disorder of pregnancy. During Garbhini Avastha increased fetal demands and improper functioning of Rasadhatu leads to Garbhini Pandu. Mother will not meet the extra demands of nutrients by diet alone. This lead to certain pathological condition in pregnant women. In addition, there is marked demand of extra iron during pregnancy specially in second half of pregnancy, even an adequate diet cannot provide the extra demand of iron. Thus, there is always remains a physiological iron deficiency state during pregnancy. 

The general principle of treatment that all the disease of pregnant women should be treated by drugs and diet which are predominantly Mrudu ( soft), Madhur ( sweet), Sheeta ( cold), Sukhakar( palatable) . All the diseases should be treated by Sanshaman Chikitsa. Gudadi Mandur is one of such drug.  Shunthi is Deepak, pachak and Raktashodhak. Pippali is Vrushya and Raktavardhak. Tila is Agnivardhak and Stanyajanak. Guda is Raktashodhak. Mandur Bhasma is considered as Raktavardhak.

Study will be conducted on 92 diagnosed patients of Garbhini Pandu ( Iron Deficiency Anemia in Pregnancy) . written consent will be taken. Initial assessment will be done. patients treated with Gudadi Mandur in interventional group and with Dhatri Lauha in control group.patient will be assessed at follow up. Observation and result will be noted and statistical analysis will be done. Discussion and conclusion will be done.

  • Null hypothesis (Ho) - Gudadi Mandur is not effective in the management of Garbhini Pandu ( Anemia in Pregnancy)
  • Alternate hypothesis ( H1)- Gudadi Mandur is effective in the management of Garbhini Pandu ( Anemia in Pregnancy)

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • 1.Diagnosed Patients Of Garbhini Pandu 2.Pregnant Women Of 21 TO 40 Years Age.
  • Patients In Between 14 Weeks To 30 Weeks Of Preganancy.
  • Hb% Above 7gm% And Below 10 gm%.

排除标准

  • Patients Suffering From Severe Aenemia Hb Below 7 gm %.
  • Age Of Garbhini Below 21 Years And Above 40 Years.
  • Anemia Due To Major Disease , Known Case Of Thalassemia, Sickle Cell Anemia, Pernicious Anemia, Aplastic Anemia And Other Complications Like Bleeding Piles And Twin Pregnancy.
  • 4.Any Other Obstetric Complication Like Pre-Eclampsia, Gestational Diabetes.
  • Patients With HbsAg , HIV, VDRL Positive.
  • Any Major Diseases that Interfere With The Corse Of Treatment.

结局指标

主要结局

Hb % will increase

时间窗: 1 month

次要结局

  • Lakshanas of garbhini pandu will dicrease.(2 months)

研究者

发起方
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Rutuja Ramchandra Yamgar

C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001

研究点 (1)

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