跳至主要内容
临床试验/CTRI/2014/09/005030
CTRI/2014/09/005030招募中2 期

A Preclinical & Clinical evaluation on Keeri Poochi Nei in the treatment of Keeri noi in children

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年6月8日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
40
试验地点
1
主要终点
Absence of ova cyst in stool examination.

研究概览

简要总结

One third of the world’s population is infected with one or more species of intestinal helminth,1 and public health specialists are concerned that these infections impair children’s growth and development. Studies have shown associations between helminth infection and undernutrition, iron deficiency anaemia, stunted growth, poor school attendance, and poor performance in cognition tests.(1) In India several studies have been carried out on the health status of school age  children.These have largely been quantitative and reported morbidity included malnutrition (10.0 – 98.0 % ) worm infestation (2.0 –30.0 %) and anemia ( 4.0 – 15.0 %)  (2) A comparitive study of intestinal parasites prevalent among children living in rural and urban settings in and around Chennai reveals that the overall prevalence of intestinal parsites under  the rural location was 91 % and in contrast under urban setting was 33 % (3) Medicinal plants have served through ages, as a constant source of medicaments for the exposure of a variety of diseases. The history of herbal medicine is almost as old as human civilization. The plants are known to provide a rich source of botanical anthelmintics, antibacterials and insecticides (4) Anthelmintic that are obtained from the natural resources may play an important role in the treatment of worm infection with less side effects (5) Lack of personal hygiene, contaminated food and poor socio-economic environmental sanitation all together contributes for the occurrence of the intestinal worm infestation. High incidence of cases was noted in the age ranging between 6 – 12 years (62%).(6). This is because school going children are more prone to this condition due to pica, unhygienic food habit and contaminated water intake and also due to over crowded situations (7) Ascariasis is caused in children,by Ascariasis lumbricoides characterized by              Abdominal pain , Loss of appetite , Perianal itching . The test drug Keeri poochi nei is chosen from the Non Sastric formulation for Keeri noi which may be correlated with that of Ascariasis. As the individual drugs ( Nigella sativa, piccorhiza korra, coccus nucifera ) of the current study have their anthelmintic activity as per our Siddha literature and recent studies on the drug, which triggered us for the study  to bring out the efficacy of the drug to the effective treatment of Keeri Noi.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Positive investigation of Stool examination with ova and cyst of worms.
  • Having complaints of loss of appetite .
  • Presence of peri anal itching .
  • Pain around the umbilicus.
  • Teeth grinding during sleep (Bruxium ) History of passing worms in the stools.
  • Willing to give both blood and motion specimen for investigation, when required.

排除标准

  • Children below 6 yrs age Patient with chronic diseases like primary complex, chronic renal failure etc., Patients not willing to give blood and motion sample for investigation Enteric fever Amoebiasis.

结局指标

主要结局

Absence of ova cyst in stool examination.

时间窗: 2-3 months

Improvement to be noticed in clinical symptoms.

时间窗: 2-3 months

次要结局

  • Safety profile of Keeri poochi nei

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验