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临床试验/CTRI/2024/04/065540
CTRI/2024/04/065540尚未招募2 期

A Phytopharmacotherapeutic evaluation of Ambasthaki Hibiscus Sabdariffa Linn Sp.Pl. calyx in the management of Pandu Roga Iron Deficiency Anaemia

Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Improvement in the symptoms of Pandu Roga (Iron Deficiency Anaemia). Increase in the HB % level. Increase in the level of range of Iron profile

研究概览

简要总结

Anaemia is defined as haemoglobin (Hb) levels <12.0 g/dL in women and <13.0 g/dL in men. Haemoglobin is needed to carry oxygen and if you have too few or abnormal red blood cells, or not enough haemoglobin, there will be a decreased capacity of the blood to carry oxygen to the body’s tissues. Various reasons of anaemia are deficiencies in foliate, vitamins A, B12, haemoglobinopathies; and infectious diseases, but major reason of anaemia is iron deficiency. Iron is abundant in HB that carries oxygenated blood to various parts of the body. Iron Deficiency Anaemia occurs when iron losses or physiological requirements exceed absorption. Blood loss in females through the menses, or blood loss from GI tract, genitourinary tract, malabsorption, pregnancy, exceed use of NSAID etc. are the main causes for iron deficiency anaemia. In Ayurveda anaemia can be well correlated with Pandu roga. Pandu is pitta pradhana vyadhi associated with rasa and rakta dhatu. In short pandu roga means raktalpata. Pandu is a clinical condition characterized by whitish yellow discoloration of skin, eyes, nails, weakness, loss of appetite, skin dryness, dyspnoea etc. Hibiscus sabdariffa L., a member of the Malvaceae family, is an annual herb having amla pradhana madhur, tikta, kashaya rasa, Amla vipaka, Dipana property. Chemical composition of Ambashthaki calyx shows that it contains iron and vitamin c which are useful in the management of the Iron Deficiency Anaemia as iron will replace deficient iron on the body and vitamin c helps in the absorption of iron, so taking these points into consideration present study is being planned to evaluate effect of Ambasthaki calyx in the management of Iron Deficiency Anaemia. Total no of patients is 66. Ambasthaki calyx churna will be given 5gm twice a day with luke warm water after meal. Study design is single arm, single centred, interventional type, clinical study.

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
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with symptoms of Pandu Roga.
  • Patients with Hb% within level of 7-11 gm /dl.
  • Patients of either sex with age group of 20-50 years.

排除标准

  • Pandu Roga in age group below 20 years and above 50 years.
  • Haemoglobin level less than 7gm/dl.
  • Anaemia due to internal bleeding, external bleeding, gastric and duodenal ulcer, haemorrhoids, pregnancy induced Anaemia.
  • Patients suffering from other systematic diseases like AIDS, Cancer, Tuberculosis, Diabetes Mellitus etc.
  • Patient with history of disorders related with haemopoietic system like Sickle Cell Anaemia, Haemophilia.
  • Patients suffering from other infectious diseases like Malaria, Jaundice etc.
  • Pregnant woman and Lactating mothers.
  • Other causes of Anaemia apart from iron deficiency, apparent by history, physical examination, laboratory tests.
  • Patients with hepatic and renal dysfunction.

结局指标

主要结局

Improvement in the symptoms of Pandu Roga (Iron Deficiency Anaemia). Increase in the HB % level. Increase in the level of range of Iron profile

时间窗: 60 days

次要结局

  • The study will provide easily available, cost effective, safe treatment modality with lesser side effects.(60 days)

研究者

发起方
Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Gitanjali Ambad

Choudhary Brahm Prakash Ayurveda Charak sansthan Khera Dabar New Delhi South west DELHI

研究点 (1)

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