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临床试验/CTRI/2024/12/077620
CTRI/2024/12/077620招募中2/3 期

Efficacy of Individualized Homoeopathic Medicines in the Treatment of Hyperuricemia in Adults: A Double-Blind, Randomized, Placebo-Controlled Trial

D N De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
Serum uric acid levels

研究概览

简要总结

Hyperuricemia is defined as an elevated serum uric acid level usually above 360 μmol/l (6 mg/dL) for women and 420 μmol/l (7.0 mg/dL) for men. In a review on population-based prevalence, hyperuricemia was placed at the 13th position among 21 Global Burden of Diseases (GBD).The majority of those who have this disorder won’t show any overt symptoms, but it’s unknown how long-term hyperuricemia may affect renal function, general morbidity, and cardiovascular health in general. Conventionally, allopurinol has only been used to treat hyperuricemia; however, The most well-known side effect of allopurinol in dermatology is its severe cutaneous adverse responses. Homoeopathy is the second largest widely accepted therapeutic system of Medicine, may offer a better alternative in prevention and treatment hyperuricemia HU. Despite the abundance of successfully treated examples of hyperuricemia and gout in homoeopathy literature, high quality research evidence is still limited. Although many good qualities clinical trial have been published under the name of hyperuricemia in Homoeopathy. But most of the randomized, placebo-controlled trial done at 1:1 ratio. So, this trial is nothing but another attempt to detect and prove the efficacy of IHMs in reducing the serum uric acid levels (SUA) by 2:1 Randomized ratio. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 64 adults who are suffering from  HU at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done using SUA levels [Primary outcomes], Questionnaire assessing impact of hyperuricemia on quality of life (HUQoLQ) score and SF -36 (Short Form-36) [Secondary outcomes] every month up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 18 and 65 years.
  • Patients of both sexes.
  • Pre-Diagnosed & newly diagnosed cases of hyperuricemia [ICD-10 -diagnosis code-E79.0] (serum uric acid level above 7 mg/dl in men and above 6 mg/dl for women) with or without gout.
  • Suspected cases of Hyperuricemia.
  • (History of attack of Gout, Family history of gout, Recurrent uric acid nephrolithiasis, obesity, hypertension, Diabetes, etc.)
  • If the patients were already undergoing treatment for hyperuricemia will be enrolled into the study after a wash-out period of one month subject to fulfilment of the eligibility criteria.
  • Patients’ ability to understand Bengali and/or English or Hindi.

排除标准

  • Denying written informed consent.
  • Overt hyperuricemia (i.e. serum uric acid levels of more than 10 mg/dL)
  • Secondary gout, severe or advanced gout requiring surgical procedures or orthopedic corrections.
  • Unstable mental or psychiatric illness or other systemic diseases affecting the quality of life or any vital organ failure.
  • Currently receiving homoeopathic treatment for any chronic condition(s)
  • Self-reported immune-compromised state.
  • Pregnant and puerperal women, lactating mothers.
  • Already undergoing homoeopathic treatment for chronic disease within last 3 months.
  • Simultaneous participation in any other clinical trial.
  • Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).

结局指标

主要结局

Serum uric acid levels

时间窗: At baseline, every month, up to 3 months

次要结局

  • Hyperuricemia quality of life questionnaire (HUQoLQ)(At baseline, every month, up to 3 months)
  • The Short Form 36 (SF-36) questionnaire(At baseline, every month, up to 3 months)

研究者

发起方
D N De Homoeopathic Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Washim Reza Molla

D N De Homoeopathic Medical College and Hospital

研究点 (1)

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