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临床试验/CTRI/2025/10/095858
CTRI/2025/10/095858尚未招募2/3 期

Randomized controlled clinical trial to determined the effect of darvyadi churna with madhu in the managment of garbhini pandu W.S.R. to iron deficiency anemia .

Dr.Suprriya Karkhilay1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年10月21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
82
试验地点
1
主要终点
Increase Hemoglobin % in 8 weeks

研究概览

简要总结

Anaemia which is most prevalent nutritional deficiency disease in both the developed and developing countries with its prevalence rate higher in children and women of child bearing age. Globally, 30% of the total world population are anaemic and half of these have Iron Deficiency Anaemia. According to WHO, 50% of children and women and 25% of men in developing countries like India are suffering from Iron Deficiency Anaemia.1

The disease Pandu has been vividly and quite in detail described in Ayurveda. There are no direct references of Garbhini Pandu (anemia in pregnancy) in Ayurveda, except Acharya Kashyapa has described Pandu as a symptom of Garbhini in the description of Rakta Gulma,2 Acharya Harita has also described Vivarnatva as one of the eight complications of Garbha.3 Pandu Vyadhi is considered as pitta pradhan. The vitiating factors of pitta can also be taken as a cause of Pandu Vyadhi. Based on the clinical features of Pandu Roga, such as Alpa Rakto (poor quality and reduced quantity of blood tissue), Swetakshi (pallor of palpebral conjunctiva), Akshikoot Shotha (periorbital edema), Nashtagni (impaired metabolism), and Nirutsah (fatigue).4 .5 Pandu Vyadhi is a disease characterized by pallor of body which resembles with ‘Anemia’ of modern science. Rakta has been considered as a key factor for the Jeevana, Preenana, dharana, and Poshana Karma of the body.6 Many times it is seen that Rakta gets vitiated by doshas, mainly by pitta dosha as Rakta and pitta share an Ashrayashrayi bhava, leading to Pandu Vyadhi.7

Considering Panduta (pallor) as the predominant sign, the disease is termed as Pandu Roga. The nearest correlation of iron deficiency Anemia (IDA) can be made with Pandu Roga, because of the predominance of Panduta or pallor in the whole body.

In modern medicine for the treatment and prevention of iron deficiency Anemia, Ferrous sulphate is used when the amount of iron taken from the diet is not adequate.9 Ayurveda can provide better management in this area. The need for discussion of Pandu becomes important because it is the commonest nutritional disorder all over the world and major problems of mankind especially in countries like India due to low economic status, illiteracy, malnutrition in a part of the population.10

Need of Study

Iron-deficiency Anemia (IDA) is the most common nutritional deficiency in the world. It manifests as a hypochromic microcytic Anemia with low blood indices and serum ferritin. IDA is the most common form of Anemia in the women of reproductive age group and is frequently seen among pregnant women in developing countries with a prevalence of 35-75 per cent.11 In India, the prevalence of Anemia among pregnant women is about 65-75 per cent12. Anemia has a significant impact on the health of the mother as well as that of the foetus. It leads to preterm delivery, intrauterine growth retardation, low birth weight, postpartum haemorrhage, cardiac failure and increased risk of infections.13 Females of lower socioeconomic status  have a lower odds of anaemia screening in pregnancy compared with higher socioeconomic status counterparts.14

In Ayurveda Pandu Chikitsa Darvyadi Churna with Madhu is mentioned by Acharya Charaka in Pandu Chikitsa.15 Darvyadi yoga contains 9 ingredients. One of its ingredients is Ayoraj (Lauha Bhasma) which makes formulation ideal indication for the treatment of Pandu Roga. it also contain Triphala and Trikatu have role in the maintenance of digestive fire (Jatharagni).16 moreover amlaki contains ascorbic acid which facilitates iron absorption by forming a chelate with ferric iron at acid pH that remains soluble at the alkaline pH of the duodenum.17 Vidanga has Krimihara properties and worm infestation is usually seen in children suffering from Pandu Roga. All the drugs are easily available in market and cost effective solution to treat Pandu. Ferrous sulphate is proven modern drug18 hence it has taken as control group.The purpose of the clinical trial is primarily to establish the efficacy of this drug as it is easy to take and having no side effects. So this study is an attempt to find a better solution for the treatment of Pandu with special reference to Iron deficiency Anemia in pregnant women. Hence study has been planned as “ Randomised controlled clinical study to determine the effect of Darvyadi Churna with Madhu in the management of   Garbhini Pandu W.S.R. to Iron deficiency Anemia”

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 35.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women, belonging to the age group of 21 to 35 years having clinical signs and symptoms of Garbhini Pandu, i.e., Panduta (pallor), Bhrama (giddiness), Daurbalya (general weakness), Shwasa (dyspnea),Akshikutshotha
  • Pregnant women of 2nd trimester and 7th month of 3rd trimester of pregnant women.
  • Pregnant women of second or third trimester of pregnancy with 7 g% to 10 .9 g% of hemoglobin
  • Microcytic hypochromic appearance of red blood cells in peripheral smear.
  • Pregnant women who give concent for study.

排除标准

  • Pregnant women suffering from pregnancy-related complications such as pregnancy-induced hypertension, hyper emesis gravidarum, pre eclampsia, etc.
  • Pregnant women with high-risk pregnancy
  • Pregnant women having severe anemia .
  • Bleeding Disorders like Haematemesis, Malena, bleeding hemorrhage etc .

结局指标

主要结局

Increase Hemoglobin % in 8 weeks

时间窗: Increase Hemoglobin % in 8 weeks

次要结局

  • Decrease breathlessness, palpitation, fatigue(In 8 weeks with oral grug)

研究者

发起方
Dr.Suprriya Karkhilay
申办方类型
Other [Own research study]
责任方
Principal Investigator
主要研究者

Dr Suprriya Karkhilay

SST Ayurveda mahavidyalay Sangamner

研究点 (1)

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