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临床试验/CTRI/2024/09/074033
CTRI/2024/09/074033尚未招募2 期

A single group pre post interventional study to assess the effectiveness of Individualized Homoeopathic Medicines of Fifty millesimal potency in the management of Hyperuricemia using Kents Repertory

Dr Aiswarya Mahankuda1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年9月28日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Decrease in serum uric acid level by assessing Uric acid reports

研究概览

简要总结

INTRODUCTION- Hyperuricemia  is a metabolic disorder characterized by increased blood serum uric acid.Normal serum uric acid range for male is 2-7 mg per dl and for female is 2-6mg per dl .International classification of Diseases eleventh revision having code( 5C55.Y- other specified inborn error of purine, pyrimidine or nucleotide metabolism) for HU. Most people with HU are asymptomatic (85% to 90%), but elevated SUA in the blood or urine can lead to gout or nephrolithiasis. HU is defined as an elevated serum uric acid level, usually greater than 6 mg per dL in women and 7 mg per dL in men.Environmental exposures like lead exposure, extreme temperature fluctuations, and physiologic stress have been found to trigger gouty flares.  It is seen that 21% of the general population and about 25% of the hospitalized patients had asymptomatic HU worldwide .Data on updated hyperuricemia prevalence in Beijing-Tianjin-Hebei  region in China shows that the prevalence of hyperuricemia was 19.37%, 27.72% in men and 10.69% in women. National Health and Nutrition Examination Survey (NHANES) data shows that the prevalence rate of HU is 20.2%  in men and 20.0% in  women  in the year 2015 to 2016 in the U.S. population.In Birbhum district of west Bengal an observational study was held which results showed that 13 among 405 people (3.2%) have found elevated serum uric acid level more than 7.0 m per dl. Modern medicines uses urate-lowering medications like Xanthine oxidase inhibitors (XOI), classified as purine-like (allopurinol and oxypurinol) and non-purine (febuxostat and topiroxostat) XOI for treatment of HU although some studies have shown that they are having many adverse effects. The five most commonly reported side effects were musculoskeletal symptoms (7.7% of who received febuxostat); upper respiratory tract symptoms (5.4%); abnormality in liver function values (4.7%); diarrhoea (3.6%); headache (2.8%).Among 122 Chinese herbal medicines some are having positive role in inhibiting Xanthine oxidase inhibitors are Glabrous greenbrier rhizome, radix puerariae, mangiferin, celery, turmeric, motherwort and berberine.

**JUSTIFICATION OF THE STUDY-**Hyperuricemia is a chronic disorder due to abnormal purine metabolism. There are evidences of cure of other metabolic diseases with Fifty Millesimal potencies are more significant and favourable as compare to centesimal potencies.The Previous studies on HU have been done with Centesimal potency but studies are scarce using Fifty millesimal potency as it was introduced by Dr Hahnemann to control the aggravations after using Centesimal potency in chronic pathological disorders. Modern medicines use urate lowering medicines like Xanthine oxidase inhibitors having adverse side effects leads to cause other systemic diseases. HU has characteristic symptoms as well as a generalized presentation. In such cases, selection of siminimum can be assorted with the help of Kent’s repertory. As it has more general symptoms of mental (527 rubrics) as well as physical (245 rubrics) which will help to reflect the inner essence of the sick. This study is undertaken to see the efficacy of Fifty millesimal Potency of individualized Homoeopathic Medicines in treatment of HU using Kent’s repertory.

RESEARCH QUESTION- Is individualized homoeopathic medicine in Fifty Millesimal potency effective in treating and improving health related quality of life of hyperuricemia patients using Kent’s repertory?

HYPOTHESIS-

**Null Hypothesis(H0):**Individual homoeopathic medicines in fifty Millesimal potency using Kent’s repertory are not effective in treating and improving health related quality of life of Hyperuricemia patients

Alternative Hypothesis (HA): Individual homoeopathic medicines in Fifty Millesimal potencies using Kent’s Repertory are effective in treating and improving health related quality of life in hyperuricemia patients.

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 70.00 Year(s)(—)
性别
All

入选标准

  • Patient reporting with serum uric acid more than 6.0 mg per dl in women and more than 7 mg per dl in men for last six months Age18 to 70 year Patient is not taking any medication for same complaints for at least 1 months Patients who are not undergo Homoeopathic treatment for last 2 weeks.

排除标准

  • Diagnosed case of unstable mental or psychiatric illness Secondary causes of Hyperuricemia with advanced pathology like Leukaemia Lymphoma Tumor lysis syndrome Pregnant and lactating mothers Substance abuse and/or dependence Self reported cases of immune compromised state.

结局指标

主要结局

Decrease in serum uric acid level by assessing Uric acid reports

时间窗: Each patient will get follow up for at least six months at interval of one month

次要结局

  • Improvement of quality of life by Eq 5d 5l Questionnaire(Each patient will get follow up for at least six months at the interval of one month)

研究者

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

Dr Aiswarya Mahankuda

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

研究点 (1)

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