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临床试验/CTRI/2014/03/004478
CTRI/2014/03/004478已完成2 期

Individualized homoeopathy versus placebo in essential hypertension: a double-blind randomized controlled trial

Mahesh Bhattacharyya Homoeopathic Medical College Hospital Government of West Bengal1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年12月4日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Change in systolic and diastolic blood pressure

研究概览

简要总结

Hypertension is the most common cardiovasculardisorder posing a major public health challenge to the population. Homoeopathy,although widely used in hypertension, is assumed to have nothing but placeboeffects and its specific clinical effects are frequently ascribed asimplausible. Aims were to evaluate whether individualized homoeopathy canproduce any significant effect different from placebo in essential hypertensionby comparing the lowering of blood pressure between groups. A prospective,double-blind, randomized, placebo-controlled, parallel arm clinical trial wasconducted at the Outpatient Clinic of the Mahesh Bhattacharyya HomoeopathyMedical College and Hospital, West Bengal. Out of 233 hypertensives assessedfor eligibility, 150 were enrolled and randomized (verum/homoeopathy 70,control/placebo 80). A total of 18 dropped out and 132 were regular (verum 64,control 68). The outcome measures were assessed after three months and sixmonths. The intention-to-treat population was subjected to statistical analysis. Group differences were tested using the χ2 test andindependent t test. Repeated measure (ANOVA) was performed to compare the dataof two groups obtained longitudinally at baseline, three months and six months.The baseline data were not significantly different between the groups. Aftersix months, mean Systolic Blood Pressure (SBP) reduction was 26.6 mm Hg (95% CI21.5, 31.7) in the homoeopathy group and SBP increased by 3.6 mm Hg (95% CI8.7, 1.5) in the placebo group. Similarly, the mean Diastolic Blood Pressure(SBP) in the homoeopathy group reduced by 11.8 mm Hg (95% CI 9.2, 14.4) andincreased by 1.6 mm Hg (95% CI 3.6, 0.4) in the placebo group. Repeatedmeasures ANOVA also showed significant difference (P=0.0001) between thegroups. Natrum muriaticum, Calcarea carbonica, Sulphur, Thuja occidentalis,Nitric acid and Medorrhinum were frequently prescribed. Thus individualizedhomoeopathy produced a significantly different hypotensive effect than placebo.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor 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

  • Age between 18 years and 65 years
  • Both sexes
  • Suffering from essential/primary hypertension for at least 6 months
  • History, examination, and routine investigations revealed no evidence of obvious secondary causes
  • Giving written informed consent.

排除标准

  • Any continued anti-hypertensive therapy for at least 6 months
  • Malignant Hypertension with grave signs and symptoms as detected clinically
  • Patients suffering from isolated systolic hypertension
  • Patients with labile hypertension
  • Patients with secondary hypertension
  • Patients not strictly conforming to the criteria given by JNC-7; variation of ±10 mm Hg in SBP/DBP considerable
  • Presence of severe concomitant infectious or systemic disease(s)or organ failure, psychiatric illness, developmental or congenital anomalies, and/or complications of hypertension
  • Pregnancy, breast feeding and likelihood of pregnancy 9.

结局指标

主要结局

Change in systolic and diastolic blood pressure

时间窗: 6 months

次要结局

  • Proportion of patients achieving reduction in the two groups(6 months)

研究者

发起方
Mahesh Bhattacharyya Homoeopathic Medical College Hospital Government of West Bengal
申办方类型
Government medical college

研究点 (1)

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