A pilot study to evaluate the effect of Drakshapanak at Serum Hemoglobin level in Iron Deficiency Anemia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Serum Hemoglobin level before and after the completion of study
研究概览
简要总结
NEED OF THE STUDY The objective of the pilot study is to evaluate the effect of Drakshapanak, an Ayurvedic Ahara kalpana from the classical literature in the management of Iron deficiency anemia. PREVIOUS RESEARCH WORK: No such previous study available. RATIONAL FOR SELECTION OF INTERVENTIONS/ JUSTIFICATION FOR SELECTION OF TRIAL DRUGS Iron deficiency anemia is one of the foremost common causes of anemia. The use of Ayurveda Aahar Kalpana can be a good solution towards the management of same since these are easily accessible besides being easy to prepare, administer, cost effective and a natural substitute to synthetic iron supplements. It may also help in avoidance of possible side effects of use of supplements.
RESEARCH QUESTIONIs Drakshapanak is effective in accession of Serum Hemoglobin levels in Iron deficiency anemia?
Study DesignStudy Type: Interventional study **(**Single group pre and post study design).
Phase of study: 2ndNumber of Groups: 1 GroupSite of study: Department of Ayurveda Diet and Nutrition, National Institute of Ayurveda, Jaipur.
STUDY SETTING: National Institute of Ayurveda, Jaipur Hospital (outdoor/indoor).
STUDY DURATION: 2 months
Details of Trail drug:
| Sr No. |
Name of IngredientLatin Name
Part used
Quantity (Ratio)
|1.
DrakshaVitis vinifera
Fruit
1
|2.
ParushakGrewia asiatica
Fruit
1
|3.
Kharjoor sarPhoenix dactylifera
Fruit
1
|4.
Kola(Badar bhed)Ziziphus Jujuba
Fruit
1
|5.
JalaWater
N. A
1
|6.
Guda(Jaggery)Saccharum officinarum
N. A
1
|7.
Ikshu Rasa (Sugarcane juice)Saccharum officinarum
N. A
1
|8.
ChaturjaatCinnamomum zeylanicum, Elettaria cardamomum, Cinnamomum tamala,
Mesua ferrea
Fruit, Leaf
Q. S
|9.
KarpurCinnamomum camphora
Extract
Q. S
|10.
MarichaPiper nigrum
Fruit
Q. S
Dose form: Liquid Time of administration: After mealRoute of administration: OrallyAnupana: NoneDuration:
· Time Frame: 8 weeks or 2 months (Including follow-up period)
· Trial Period: The duration of study will be for 8 weeks.
· Follow Up:
Ø First follow up on 2nd week or on 15th day.
Ø Second follow up on 4th week or on 30th day.
Ø Third follow up on 6th week or on 45th day.
Ø Fourth follow up on 8th week or on 60th day.
INVESTIGATIONS:
| Name of Investigation |
Purpose
Timings for Investigations
|Serum Hemoglobin
To diagnose mild to moderate anemia.
Before and after completion of study.
ASSESSMENT CRITERIA: The result of clinical study will be assessed on the basis of changes in Serum Hemoglobin levels before and after the completion of 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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group
- •45 years of either sex that are previously diagnosed with Iron Deficiency Anemia.
排除标准
- •Severe anemic patients Lactating and Pregnant women Women planning pregnancy Using vitamin and mineral supplements Frequent blood donors Have had major surgeries in the past 3 months Plan of surgery in course of study Alcohol consumption Known cases of; Ulcerative colitis, chronic kidney disease, diverticular bleeding, irritable bowel syndrome, helicobacter pylori, hookworm infestation, blood clotting disorders.
- •Using NSAIDs, antacid, corticosteroids, antiviral drugs.
结局指标
主要结局
Change in Serum Hemoglobin level before and after the completion of study
时间窗: 2 Months
次要结局
- N.A(N.A)
研究者
Vaidya Shivani Sanjay Saxena
National Institute of Ayurveda Jaipur