跳至主要内容
临床试验/CTRI/2024/07/071154
CTRI/2024/07/071154已完成3 期

Prospective single arm open clinical trial to study the efficacy of Yakridari Loha in the manangement of Pandu in Udara with special reference to Anemia in Liver Cirrhosis.

Dr Farheenben Vohra1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月7日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the hematinic effect of Yakridari Loha in Pandu in Udara

研究概览

简要总结

Current Clinical Trial is Titled as " Prospective single arm open clinical trial to study the efficacy of Yakridari loha in the management of pandu in udara with special reference to Anemia in Liver cirrhosis".

The trial drug used in this clinical study is Yakridari loha which will be given in the dose 500mg twice a day for 21 days.

The sample size of this study will be 30.

It is single arm prospective open clinical trial.

The patient will be  selected from opd and Ipd of our concerned institute.

the purpose of the trial is to assess the efficacy of Yakridari loha.

The Null Hypothesis for this trial is -Yakridari Loha 500mg orally twice a day for 21 days is not effective in the management of Pandu in Udara with special reference to Anemia in liver Cirrhosis.

The Alternate Hypothesis for this trial is -Yakridari Loha 500mg orally twice a day for 21 days is  effective in the management of Pandu in Udara with special reference to Anemia in liver Cirrhosis.

Observation and Results -

Above clinical research study in 30 patients of Pandu in Udara w.s.r. to  Anemia in Liver Cirrhosis with Yakridari Loha shows following results

In subjective criteria it is evident that total no of patients shows

59.68% relief in Panduta parameter, 52.28% relief in Hridspandana, 57.69% relief in Shwaskashtata, 71.67% relief in Daurbalyata, 68.75% relief in Aruchi, 68% relief in Agnimandya, 75.68% relief in Pindikodwestana and 30.30% relief was seen in Pada shotha.

Overall 60.52% relief is observed in subjective criteria.

In objective criteria, for Hb%, statistically high significant difference was seen in values between the time intervals. For total bilirubin and SGPT also, statistically significant difference was seen in values between the time intervals. Hence, Hb%, T.B. and SGPT showed statistically significant result. Whereas, in TLC, ESR, SGOT, Blood urea, Serum creatinine, Urine RBCs and Urine Albumin parameters, there was statistically no significant difference seen in values between the time interval. Therefore, these parameters showed statistically not significant result.

Tab Yakridari Loha showed marked improvement (i.e.76%-100%) in 12(40%) patients of Pandu in Udara with special reference to anemia in liver cirrhosis. It showed Moderate improvement (i.e. 51%-75%) in 12 (40%) patients and gave mild improvement (i.e. 26%-50%) in 2(6.67%) patients. 3 (10%) patients showed no improvemet (i.e. 0%-25%) to Tab Yakridari Loha.

Conclusion -

Based on P value, it can be concluded that the Null Hypothesis is rejected and the Alternative Hypothesis can be retained, indicating that Yakridari Loha is effective in the management of Pandu In Udara w.s.r. to Anemia in Liver Cirrhosis.

There is no noticeable adverse effects of the drug observed during the treatment period. Yakridari Loha is clinically safe and effective preparation that does not have any side effects in managing Pandu in udara when combined with proper Pathya and Aahar-Vihar.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients having cardinal signs and symptoms of Pandu in Udara as per ayurvedic texts without any bar of caste, sex and religion.
  • 2.Patients having Haemoglobin level between 5 to 12gm%.

排除标准

  • 1.Chidrodar 2.Acute MI 3.Malignancy 4.Pregnancy 5.Hepatic Encephalopathy 6.SLE 7.Recent MI 8.Patient in condition of precoma and coma(Overt & Covert Coma) 9.HIV & HBsAg positive patients 10.Complicated Liver Disorders with ascites 11.Congenital & hereditary disorders.
  • 12.Metabolic Disorders like Myxedema, Thyroid etc.

结局指标

主要结局

To evaluate the hematinic effect of Yakridari Loha in Pandu in Udara

时间窗: 21 days

次要结局

  • 1.To evaluate the hematinic effect of Yakridari Loha in Pandu in Udara
  • 2.To study the adverse effects of Yakridari Loha, If any.(7th, 14th & 21st day.)

研究者

发起方
Dr Farheenben Vohra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Farheenben Vohra

Seth Chandalmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara

研究点 (1)

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