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临床试验/CTRI/2024/07/070273
CTRI/2024/07/070273尚未招募2/3 期

Effect of Ellum Tippalyadi Lehya in Iron Deficiency Anemia

Government Ayurveda College and Hospital Tripunithura1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年9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
34
试验地点
1
主要终点
Increase in Serum Haemoglobin Level of Participants

研究概览

简要总结

Iron deficiency anemia is the most prevalent form of anemia in the society. Iron deficiency

occurs primarily due to poor dietary intake of iron and also its poor absorption from intestine. Severe

blood loss, as in heavy menstruation, bleeding piles and other hemorrhagic diseases is also a major

etiological factor for this disease. Ayurveda correlates iron deficiency anemia to Pandu. A wide range

of formulations, both herbal and herbo mineral are explained in Ayurveda Samhitas for its management.

Ellum tippalyadi lehya is one such formulation, mentioned in Sahasrayoga. Basically, it is a lohakalpa

in avaleha form. It contains Tila, Pippali, Badara, Lohabhasma, Makshika bhasma, and Shundi and is

indicated in Arshas, Pleeha, Pandu etc. The primary treatment for iron deficiency in conventional med

icine is oral supplementation of iron compounds like ferrous fumarate,ferrous gluconate, ferrous sul

phate etc. But these are often associated with gastric discomforts like nausea vomiting, constipation or

diarrhea, flatulence, metallic taste, staining of teeth or epigastric distress. Ellumtippalyadi lehya can be

effective in iron deficiency anemia owing to the properties of its ingredients, which improves digestion,

reduces the gastric discomforts and also helps in better absorption of iron. A study will be conducted

among people of 18 to 60 years of age to evaluate the effect of Ellum tippalyadi lehya in reducing the

symptoms of iron deficiency anemia. The type of study is single group pre and post interventional.

Participants satisfying the inclusion and exclusion criteria will be selected from the OPD of Government

Ayurveda college Hospital, Tripunithura. Assessment will be done before and after the treatment. Re

sults will be analysed statistically. The data obtained before treatment on 0th day and after the treatment

on the 31st day will be used for statistical analysis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants between 18 to 60 years of age irrespective of sex having Serum Haemoglobin level less than 12gm/dl in females and below 13gms/dl in males.

排除标准

  • Participants with Haemoglobin less than 7gm/dl Participants with Anemia of other Known Cause Participants with Diagnosed Renal, Hepatic, Cardiac Diseases Participants Suffering from Cancer or Other Life-threatening Diseases Participants having severe Blood loss conditions like Heavy Menstruation and Bleeding Piles Pregnant And Lactating Women Participants who are taking any other iron Supplements.

结局指标

主要结局

Increase in Serum Haemoglobin Level of Participants

时间窗: 30 days

次要结局

  • Decrease in Severity of Subjective Criteria such as Pallor, Weakness, Fatigue, Anorexia, Irritability, Dyspnea, Palpitations(30 days)

研究者

发起方
Government Ayurveda College and Hospital Tripunithura
申办方类型
Other [Government Ayurveda College]
责任方
Principal Investigator
主要研究者

Dr N Srilakshmi

Government Ayurveda college Tripunithuru

研究点 (1)

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