A Randomized Controlled Trial of Ragi Modak (Finger Millet) as a Dietary Supplement in Iron Deficiency Anemia among Adolescents.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- 1.To study the effect of Ragi Modak on Iron Deficiency Anemia.
研究概览
简要总结
Title A Randomized Controlled Trial of Ragi Modak (Finger Millet) as a Dietary
Supplement in Iron Deficiency Anemia among Adolescents.
Aim To study the effect of ragi modak (Finger Millet)as a dietary supplement in iron
deficiency anemia among Adolescents.
Objectives Primary Objectives
To study the effect of Ragi Modak on Iron Deficiency Anemia.
To compare the clinical efficacy of Ragi Modak with that of Iron & Folic acid
Supplement
Secondary Objectives
To study the effect of Ragi modak on sign and symptoms of iron deficiency
anemia (Pandu) and Calcium deficiency (Asthikshaya)
To Study and collect literature regarding Ragi (Finger Millet) from Ayurvedic
classical & Modern texts
To review the literature regarding Pandu & Anemia from Ayurvedic classical
& Modern texts
Methodology study design
Study design An open label, Randomized Controlled Trial
Screening of the School going Adolescents will be done on the basis of Inclusion and
exclusion criteria
76 subjects will be selected for the study
Informed consent from their Parents or Guardian will be taken
They will be divided into two groups randomly by computerised random
sampling method
Group A Trial group 38 Individuals will be given Elemental iron 60 mg plus 500mcg folic acid
2BD plus 2BD Ragi Modak for 60 days and group B will be given Elemental iron 60 mg plus 500 mcg folic acid
2BD
Then Assessment will be done by Objective on D-0 ,D-60 and Subjective Parameters
On Day 0 Day 30 and Day 60 before and after study
Statistical analysis with appropriate test and interpretation will be done
Observation and Result
Discussion
Conclusion
a Inclusion criteria
- Individuals between the age group of 10 to 18 years irrespective of sex, religion,
education, socio economic status.
-
The subject having Hb greater than 8gm per dl less than11.4 gm per dl.
-
Parents or Guardian willing to give informed consent to participate in study.
b. Exclusion criteria:
-
Subjects having any systemic and congenital diseases.
-
Subjects suffering from Anemia due to other systemic disorders or infections.
-
Having any type of bleeding disorders.
-
Subjects not willing for Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals between the age group of 10 to 18 years irrespective of sex, religion, education, socio economic status.
- •The subject having Hb more than 8gm per dl and less than 11.4 gm per dl.
- •Parents or Guardian willing to give informed consent to participate in study.
排除标准
- •Subjects having any systemic and congenital diseases.
- •Subjects suffering from Anemia due to other systemic disorders or infections.
- •Having any type of bleeding disorders.
- •Subjects not willing for Trial.
结局指标
主要结局
1.To study the effect of Ragi Modak on Iron Deficiency Anemia.
时间窗: 30,60 days
2. To compare the clinical efficacy of Ragi Modak with that of Iron & Folic acid
时间窗: 30,60 days
Supplement.
时间窗: 30,60 days
3. To study the effect of Ragi Modak on Haematological Parameters viz Serum Iron, Hb, MCV, MCH, MCHC.
时间窗: 30,60 days
次要结局
- 1.To study the effect of Ragi modak on sign & symptoms of iron deficiency(anemia (Pandu) & Calcium deficiency (Asthikshaya))
研究者
Dr Varsha Sagar Karyappa
Government Ayurved college and Hospital, Nagpur.