跳至主要内容
临床试验/CTRI/2025/09/094260
CTRI/2025/09/094260尚未招募不适用

A comparative clinical study to evaluate the effect of Yashtyawha kal basti and Tab. Febuxostat (40 mg BD) in Vatrakta w.s.r Gout

Dr Anushri Vasant Netke1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
135
试验地点
1
主要终点
The effect of Yashtywha kal basti and tab febuxostat 40 mg and combined effect of both treatment in Vatrakta w.s.r. Gout

研究概览

简要总结

There’s no optimal cure for Gout in modern science as analgesics, uric acid reducer, nonsteroidal anti-infammatory drug and steroid  thus an attempt has been made to  bridge the gap in studying and standardizing the mentioned basti karma.   Instead of the wide range of success of Panchakarma in Vatrakta treatment there are very few published data available or the data available is in the form of single arm study or non controlled clinical trial, so, to validate the data we need more clinical trials on Basti.

Aims and Objectives-Aims Clinical evaluation and comparison of clinical efficacy (including symptomatic relief Sr. Uric Acid levels and CRP levels) and overall improvement by Yashtyawha Kal Basti alone, Tab Febuxostat (40 mg BD) and Yashtyawha Kal Basti combined with Tab Febuxostat (40 mg BD) only in the treatment of Vatrakta w.s.r to Gout. Objectives     To evaluate the effect of Yashtyahwa Kal basti in the patients of vatrakta over a treatment period of 15 days.   To evaluate the effect of Tab Febuxostat 40 mg BD in the patients of vatrakta over a treatment period of 15 days.    To compare the clinical efficacy of Yashtyahwa Kal basti with Tab Febuxostat 40 mg BD in treatment of Vatrakta over a total duration of 45 days.  To study the combined effect of Yashtyahwa Kal basti and Tab Febuxostat in Vatrakta over a total duration of 45 days.Method Of Selection Of Study

Subjective   Diagnosis Criteria:-

Diagnosis is done based on the sign and symptoms of Vataraktai.e.

Sandhi Toda (Pricking Pain of Joints)

Sandhi Daha (Burning Sensation of the Joints)

Supthi (Numbness)

Sparshaasahyatha (Tenderness)

Raaga (Discolouration of Joints)

Sandhi Shotha (Swelling)

Methodlogy

Group A (Trial) - Yashtyahwa Niruha Basti  (45 Sample)

Group B (Control) – Tab. Febuxostat 40 mg x BD (45 Sample)

Group A (Trial) - Yashtyahwa Niruha Basti and Tab. Febuxostat 40 mg x    BD (45 Sample

Data Analysis Plan and MethodsData Management and Analysis Procedure

1.      Collected data will be summarized in the form of master charts.

Further classification and presentations will be done in the form of tables and graphs.

3.      Finally, data will be analyzed statistically to draw conclusions.

 Plan For Statistical AnalysisResult of study will be calculated statistically with appropriate statistical method for subjective and objective criteria.

Data collected will be analyzed by statistical tests

As well as another relevant test if required.

DiscussionDiscussion will be done on the basis of observations and result obtained during the treatment of patients.

Summary and Conclusion On the basis of observations, discussion and result; summary will be draw and whole    thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical  analysis and will be unbiased.

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

入选标准

  • Diagnosed Patients presenting with classical clinical features of Vatarakta.
  • Basti Yogya Patients
  • Increased sr.
  • Uric acid levels more than 7mg/ dl in male and more than 6 mg/dl in female.

排除标准

  • Pregnant Women and Lactating Mother
  • Hemorthrosis, Koch’s Arthritis, Septic Arthritis, Chronic Renal Failure, Severe Systemic Multi organ syndromes
  • Patient having any other systemic disorder viz.
  • Diabetes Mellitus, Hypertension, abnormal liver enzymes etc.
  • Basti Ayogya Patients
  • Patients with long standing use of corticosteroids
  • Gout with complications- joint damage, joint deformity, bone loss, tophi deposits etc.

结局指标

主要结局

The effect of Yashtywha kal basti and tab febuxostat 40 mg and combined effect of both treatment in Vatrakta w.s.r. Gout

时间窗: BASELINE,1ST, 16TH, 45TH

次要结局

  • • To evaluate the effect of Yashtyahwa Kal basti in the patients of vatrakta over a treatment period of 15 days.(• To evaluate the effect of Tab Febuxostat 40 mg BD in the patients of vatrakta over a treatment period of 15 days.)

研究者

发起方
Dr Anushri Vasant Netke
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Anushri Vasant Netke

AYUSH

研究点 (1)

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