Promoting the Ayurvedic intervention for Iron Deficiency Anemia (IDA) among tribal females (18 to 45 years of age) in Mawpat and Mylliem Block of East Khasi Hills District of Meghalaya
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 3,750
- 试验地点
- 1
- 主要终点
- Awareness about the anaemia, screening of haemoglobin level in females of age 18 to 45 years in said area, evaluation of the effectiveness of Ayurveda interventions in the prevention and treatment of anemia on a mass scale, decrease in mortality rate due to IDA and overall well being of female.
研究概览
简要总结
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Firstly recruitment of manpower for study and purchase of said equipment, reagents, etc. will be made.
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Awareness training and workshop programs will be organized for health workers as well as locals regarding the importance of dietary and hygiene habits in personal as well as community health status. Distribution of IEC material will be circulated among the selected area.
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Further screening for Anemia will be done by questionnaire among the female population of Mawpat and Mylliem Block of East Khasi Hills district of Meghalaya by organizing the awareness cum screening camps by the recruited mobile camp team. (30,000 females).
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On the basis of questionnaire, those females who report symptoms of anaemia and will give consent will be screened for Haemoglobin percentage (Hb %) by digital hemoglobinometer. (15,000 females).
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On the basis of Hb% those consented females who are going to fall under the range of moderate anaemia (more than 8gm/dl less than10.9 gm/dl) will undergo further lab investigation for CBC. (75,00 females)
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On the basis of MCHC (less than 30%) & MCV (less than 87 cubic micron) value & Hb level (more than 8gm/dl less than 10.9 gm/dl) the consented females will undergo the medication. (3750 females)
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For initial 7 days females will undergo deworming by Krimimudgar Ras as per specified doses.
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Further for 90 days females will be given Purnarva Mandoor and Drakha Aveleha in specified doses.
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At the end of 90 days the females have to undergo post lab test for CBC. (3750 females)
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Among the selected 3750 females for treatment 1500 will be selected randomly for pre & post serum ferritin (Day 0 & Day 97).
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Two-three camps in each block in a month planned by dividing the total area in specified subgroups making it stratified sample survey study.
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Nutritional assessment will be made on the 24-hour dietary recall method and quality of life assessment will be made via the WHOQOL-BREF questionnaire.
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All the data collected will be statistically analyzed and publications will be made. 14. Further a comparative analysis could be undertaken between the current study & the effect of modern medicines within same inclusion & exclusion criterias data available or published online or provided by the concern authority.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Hemoglobin level between 8gm to 10.9gm/dl.
- •Willing to provide informed written consent for participation in the study.
排除标准
- •Recent history of severe acute or chronic blood loss from the gastrointestinal or other sources in the form of Haematemesis, Melena, Bleeding Piles, Hemoptysis, Menorrhagia, malaria, surgery & traumas.
- •Known case of pernicious Anemia, anemia due to chronic disease and medications, Thalassemia, sickle cell anemia, Bone marrow suppression (aplastic anemia) mechanical heart valves, hemolytic uremic syndrome (HUS) or Hypothyroidism.
- •Patients already on iron supplements at present or during the last 3 months.
- •Known case of disease conditions with intestinal malabsorption, alcohol use disorder (AUD), (CAGE score more than 2).
- •Known case of other major co-morbidities like chronic cardiac or pulmonary diseases & malignancy.
- •Known cases with concurrent serious Hepatic Dysfunction or Renal Dysfunction.
- •Patients on prolonged (more than 6 weeks) medication (steroids, immunosuppressants, disease modifying agents, chemotherapy etc.) for any chronic disease that may have an influence on the outcome of the study Pregnant women or lactating mothers.
结局指标
主要结局
Awareness about the anaemia, screening of haemoglobin level in females of age 18 to 45 years in said area, evaluation of the effectiveness of Ayurveda interventions in the prevention and treatment of anemia on a mass scale, decrease in mortality rate due to IDA and overall well being of female.
时间窗: ï¶ Twice Post-intervention follow-up after completion of medicine and tests, after 15 days and 30 days via telephone.
次要结局
- To estimate the prevalence of IDA among(reproductive age women of said areas.)
研究者
Dr Manoj Nesari
Northeastern Institute of Ayurveda and Homeopathy