A Comparative clinical study to evaluate the efficacy of Vidangadi Churna with that of Krimighna Dashemani Churna on Krimi Roga (Worm infestation) in Children.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in the clinical features of Krimi Roga.
研究概览
简要总结
INTRODUCTION:
Helminthic infestations contribute to global burdenof diseases in children, especiallyin tropical and subtropical regions. Epidemiologicalsurveys regarding worm infestation in various part of the country reveal a highincidence of helminthiasis. Slums and rural areas are highly effected probablydue to defective measures of sewage disposal an poor practices of hygiene. Krimi(Helminthic infestations) can cause health problems in children like nutrientsdeficiency, anaemia, skin diseases, diarrhoea, pain in abdomen etc.
OBJECTIVES OF THE RESEARCH
-
To assess the Krimighnaeffect of Vidangadi churnaby thereduction/absence of Ova and Cysts or either of them in stool examination.
-
Toassess the effect of Vidangadi churnainother associated symptoms of krimii.e.
-
To improve the quality of life of thechildren.
METHODOLOGY:
TYPE OF STUDY DESIGN**:** a randomized, SINGLE blind, DOUBLE ARM, INTERVENTIONAL,comparative STUDY.
SAMPLE SIZE **:**60 patients (30 in each group)
GROUPING AND DRUG DELIVERY REGIMEN:
Group A : Vidangadi Churna twice a day with honey.
Group B: Krimighna Dashemani Churna twice a day with honey.
| S.No |
Age (Yrs)
Dose
(Krimghna dashemani churna / Vidangadi churna)
|1.
3-5
3 gm in divided doses
|2.
6-9
~= 4.5 gm in divided doses
|3.
10-12
~= 6 gm in divided doses
DURATION: 4 weeks.
FOLLOW UP: 1 month with fortnightly visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group- 3 years to 12 years.
- •Children with symptoms of Krimi (worm infestation) and positive stool examination result for ova and cysts.
- •Children of either gender, irrespective of caste, religion, and socio-economic status will be taken.
- •Parents/Guardians willing to give informed written consent to participate in the study.
排除标准
- •Children below 3 years and above 12 years of age.
- •Negative Ova or Cysts in stool.
- •Other non-intestinal parasitic infestation.
- •Children with chronic ailments like tuberculosis, malignancy or other severe conditions etc.
- •Parents/Guardians not willing to give informed written consent to participate in the study.
结局指标
主要结局
Reduction in the clinical features of Krimi Roga.
时间窗: 0 day, 8th day, 15th day, 22nd day and 29th day.
次要结局
- 1) Stool examination result negative for ova and cyst.(2) Changes in the haematological and bio-chemical parameters.)