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临床试验/CTRI/2025/10/096536
CTRI/2025/10/096536尚未招募2/3 期

A Randomized Controlled Trial to Evaluate the Efficacy of Gomutra Bhavita Lohbhasma with Milk in the Management of Pandu with Special Reference to Iron Deficiency Anemia

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
141
试验地点
1
主要终点
Change in hemoglobin levels from baseline to week 8

研究概览

简要总结

Anemia, particularly iron deficiency anemia, is a major global health concern, affecting a large proportion of the population, especially women and children in developing countries like India. The present study is a randomized controlled trial designed to evaluate the efficacy of Gomutra Bhavita Lohabhasma with milk in the management of Pandu with special reference to iron deficiency anemia. Lohabhasma, an Ayurvedic formulation, is traditionally used to replenish iron stores and enhance hematopoiesis. The Bhavana process with Gomutra is believed to potentiate its efficacy and detoxify the metal component, while milk as an adjuvant supports nourishment and reduces gastrointestinal irritation. The study will include 141 participants randomly divided into three groups: Group I will receive Gomutra Bhavita Lohabhasma with milk, Group II will receive the same drug with water, and Group III will receive standard iron supplementation. The treatment period will be 8 weeks with follow up every 15 days. Hemoglobin and other hematological parameters, along with clinical symptoms of anemia, will be assessed before and after treatment. This research aims to validate the traditional Ayurvedic approach using modern clinical methodology and to explore a safe, effective, and culturally acceptable alternative in the management of iron deficiency anemia.

研究设计

研究类型
Interventional
分配方式
Other
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

  • Individuals diagnosed with iron-deficiency anemia.

排除标准

  • Severe anemia.
  • Patients with Lactose intolerance.
  • Patients with systemic diseases, bleeding disorders or on other iron supplements.

结局指标

主要结局

Change in hemoglobin levels from baseline to week 8

时间窗: baseline and week 8

次要结局

  • Changes in haematological parameters such as Heamoglobin, Serum Iron Level,(Serum Ferritin, Total Iron Binding Capacity etc.)
  • Improvements in anemia-related symptoms, such as fatigue, weakness, and(pallor.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Haritha T N

National Institute of Ayurveda

研究点 (1)

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