A randomized controlled clinical trial to study the efficacy of Vidangadi Mandura in panduroga with special reference to iron deficiency anaemia in school going children.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Hb% with sign and symptoms.
研究概览
简要总结
According to NFHS4 prevalence of Iron deficiency anemia in Urban area is 55.9%, Rural is 59.4% & overall is 58.4%. Anaemia has impact on neurological development. Iron Deficiency can hamper both physical and mental development of child.Prominent diagnostic feature of Pandu is pallor on skin which occur due to quantitative and qualitative deficiency of Raktadhatu. Anaemia is well treated by modern drugs but there are many limitations & side-effects such as constipation, nausea, vomitting.
Null hypothesis-Vidangadi Mandura is not effective in Panduroga
Alternative hypothesis_Vidangadi Mandura is effective in Panduroga.
Ayurved samhita has given much good formulations on Pandu. One of these formulations is Vidangadi Mandura. Vidangadi Mandura contains dravyas which are dipana ,pachana, raktavardhak properties. Vidangadi Mandura contains Mandura bhasma which is better in children as compared to Lohbhasma. Conducting Research to evaluate effectiveness of Vidangadi Mandura in Panduroga is crucial for exploring our understandings of traditional remedies and their applications in modern helathcare. By filling knowledge gap study can provide valuable insights into potential benefits of Vidangadi Mandura and its role in managing Pandu. Including patients within school age grouop who fulfill clinical diagnostic criteria for Pandu are selected irrespective of sex, socioeconomic status and community helps in achieving a diverse diverse and representative sample enhancinng the generalizability of study findings. Written consent from parents ensures ethical compliance and transparency in treatments. Total 100 number of patients will be selected and divided into two groups named as Group A (Trial Group) & Group B (Control Group) will be given to the patients. Simple random sampling techniques will be used. Trial and Control drug will be purchased from GMP certified pharmacy. Both drugs will be administered in vati form for 30 days. All SOP of vati form will be strictly given before meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children having haemoglobin 8-11.4gm/dl 2.Patients diagnosed as iron deficiency Anaemia by performing CBC.
排除标准
- •1.Anaemia other than Iron deficiency Anaemia 2.Patients requiring hospitalization, blood transfusion 3.Haemoglobin percentage less than 8gm/dl.
- •Acute bleeding due to recent trauma.
结局指标
主要结局
Change in Hb% with sign and symptoms.
时间窗: 30 days
次要结局
- Comparison with Trial and control group.(18 Months)
研究者
Dr Shubhangi Rajendra Divekar
SMBT Ayurveda college and Hospital
