Efficacy of Individualized Homoeopathic Medicines in the Treatment of Hyperuricemia in Adults: A Double-Blind, Randomized, Placebo-Controlled Trial
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
Washim Reza Molla
D N De Homoeopathic Medical College and Hospital
