跳至主要内容
临床试验/CTRI/2022/11/047625
CTRI/2022/11/047625尚未招募2/3 期

Comparative controlled clinical study to evaluate efficacy of Indrashani Choorna and ferrous sulphate in Pandu Vyadhi with special reference to iron deficiency anemia.

Dr Ritesh D Damle2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2022年1月12日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
162
试验地点
2
主要终点
To observe the changes in signs and symptoms of Pandu with use of Indrashani

研究概览

简要总结

For the present study, Indrashani Choorna mentioned in Choorna chapter of Sahasrayoga, has been selected, which comprises of Tila, Pippali, Badara, Madhu, Makshika, Ayas, Shunthi and Sita. The research hypothesis is that, Indrashani choorna is helpful in the management of Panduroga with special reference to Iron deficiency Anaemia.

Expected outcome:• Significant improvement in subjective and objective parameters is expected in this comparative clinical study.• Jujube (Badara) was reported to contain numerous minerals. About 0.48 mg iron and 69 mg vitamin C per 100 g of fresh fruit were reported. Being intrinsically rich in potassium, phosphorus, manganese, iron, zinc these minerals help in maintaining cardiac health. Jujube is a great way to pump iron reserves, improve hemoglobin count and regulate thus, the daily intake of jujube could increase our dietary iron and vitamin, as to prevent anemia due to deficiency of iron or vitamin C.Hence, Indrashani choorna is expected to increase Hemoglobin level, significantly.• Since, Indrashani choorna is combination of indigenous compound drug, it is expected to get well tolerated and clinically safe and better alternative for ferrous sulphate which is having much adverse effect in management of IDA.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • “Pandu Vyadhi†will be diagnosed on the basis of symptoms of Pandu Vyadhi. 2) Age: 18-60 Yrs. Irrespective of gender, religion, Socio.
  • economic status, marital status. 3) Hb % more than 7 gm% & less than normal i.e. Male -< 13g / dl. And female -<12g/dl. 4) MCV less than normal. [
  • 100 fl]. 5) PBS – Microcytic hypochromic (morphology) 6)Sr. Iron: below 70 mcg.

排除标准

  • Known case of Endocrine disorders like Diabetes mellitus, hypothyroidism, Cushing syndrome, etc.
  • Pregnant and lactating lady.
  • Patient having Tuberculosis, known case of HIV, leprosy, any type of cancer.
  • Patient showing signs and symptoms of internal bleeding Haemorrhoids, menorrhagia etc.

结局指标

主要结局

To observe the changes in signs and symptoms of Pandu with use of Indrashani

时间窗: At Day 0, Day 15th, Day 30th, Day 45

Choorna while comparing with ferrous sulphate.

时间窗: At Day 0, Day 15th, Day 30th, Day 45

次要结局

  • To observe the changes in biochemical parameters in patients of Pandu Vyadhi with(the use of Indrasani Choorna while comparing with ferrous sulphate. (Hb, MCV,)

研究者

发起方
Dr Ritesh D Damle
申办方类型
Other [self]

研究点 (2)

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