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临床试验/CTRI/2026/01/100567
CTRI/2026/01/100567尚未招募3 期

A Randomized controlled clinical study to evaluate the Haematinic effect Of Dhatri Avaleha over Ferrous Sulphate in IDA among Adolescent Girls.

Dr Vaishnavi Pawale1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1

研究概览

简要总结

Iron Deficiency Anaemia (IDA) is considered as one among the top 10 risks globally and regionally contributing to the 14th leading cause of disease burden in the world. IDA is characterized by a defect in haemoglobin synthesis, resulting in hypochromic and microcytic red blood cells. According WHO a person is said to be anaemic when the haemoglobin concentration is less than 12.0 gm/dl. So its deficiency due to either physiological or pathological reason can affect mental and physical growth resulting in decreased learning capacity and work productivity. In absolute numbers anaemia affects 1.62 billion people globally. Although IDA occurs at all age and involves both the sexes, adolescent girls are more prone to it. There are many reasons of IDA in adolescent girls such as deficient intake or absorption of iron, increased demand during adolescence, heavy blood loss during menstruation and parasitic infestation. The requirement for iron in fact doubles during adolescence as compared to younger age. There is a significant increase in the requirement of iron from pre-adolescent level of approximately 0.7 to 0.9 mg iron per day to 1.40 to 3.27 in adolescent girls. Due to high prevalence of anaemia (Haemoglobin less than12 gm. percentage) among adolescent girls in India, causes 1.8 percentage loss of GDP. Therefore, the burden of anaemia is disproportionately higher in women as compared to men.

According to a study by WHO on anaemia during 1993 to 2005, worldwide prevalence of anaemia was 25 percentage. The prevalence of anaemia among adolescent women in India increased from 54.2 percentage (99 percentage CI 53.6 to 54.8) to 58.9 percentage (99 percentage CI 58.3 to 59.5) over the study period (2015 to 16 to 2019 to 21). Among the 28 Indian states, 21 reported an increase in the prevalence of anaemia. The National Family Health Survey 3 (NFHS 3) data suggests that the prevalence of anaemia in adolescent girls (15 to 19 years) is 56 percentage. According to National Nutrition Monitoring Bureau Survey (NNMBS) 2006, the prevalence of anaemia in adolescent girls (12-14 years) is 68.6 percentage whereas in (15 to 17 years) it is 69.7 percentage. The highest prevalence is between the ages of 12 and 15 years when the requirements of iron are at peak. More than 50 percentage girls in this age group have been reported to be anaemic. Due to the rise in anaemia prevalence among adolescent girls in India it suggests the need for targeted interventions to mitigate the burden of anaemia and enhance the overall health of this population. Main line of treatment according to modern science is considered to be use of Iron supplements (Iron drops or pills). Iron supplements such as ferrous sulphate, ferrous fumerate, ferrous succinate etc. are used in day to day practice but it has various side effects which are frequently encountered such as irritation in the gastrointestinal system, constipation, nausea, vomiting and epigastric pain etc.

In Ayurveda Iron Deficiency Anaemia (IDA) can be clinically compared with Kaphaj pandu roga, because of the predominance of panduta or pallor in the whole body. According to Ayurveda classics it is considered as a santarpanotha vikara. Pandu roga requires treatment such as snehana, tikshna vamana virechana anduse of shaman aushadhis. Shaman aushadhis possessing katu-tikta-usna-guna propertiesare needed. As per this Datri Avaleha mentioned in charaka samhita pandu chikitsa adhyay is said to be having ingredients like amalaki, vanshlochan, draksha, shunthi, yasthimadhu, pippali which contains iron constituents in some ingredients along with that they are balya, pachak, rasayana, GIT stimulant, hepatoprotective, and antioxidant. Though there are many louha formulations mentioned in Ayurvedic classics but due to their non-acceptance and assumed complications from modern system of researches they are usually not preferred by the consumers. So to find out safe and effective herbal medicines that can manage adolescent IDA without any side effects the present study has been chosen to find the Haematinic effect of an Ayurvedic herbal compound named Dhatri Avaleha over Ferrous Sulphate among adolescent girls belonging to 10 to 18 years of age.

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
10.00 Year(s) 至 18.00 Year(s)(—)
性别
Female

入选标准

  • Adolescent girls belonging to age group between 10-18 years with classical signs and symptoms of Panda roga, irrespective of caste and religion will be included in the study.
  • 2.Adolescent girls having hemoglobin percentage between below 12gms to above 8 gm.
  • With microcytic hypochromic anemia will be included.

排除标准

  • 1.Adolescent girls with severe anaemia (below 8 g/dl) and mild-moderate anaemia associated with other systemic disorders like TB, HIV, Cancer, etc.
  • 2.Haemolytic disorders like Thalassemia, Sideroblastic anaemia.
  • 3.Other known cases haemorrhagic diathesis like Haemophilia, ITP, Vit K deficiency etc.
  • 4.Patients on any other medications or health supplements since 4 weeks.

研究者

发起方
Dr Vaishnavi Pawale
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vaishnavi Sadanand Pawale

Shree Jagadguru Gavisiddheshwara Ayurvedic College, Koppal.

研究点 (1)

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