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临床试验/CTRI/2019/02/017576
CTRI/2019/02/017576已完成3 期

Efficacy of individualized homoeopathic medicines in treatment of atopic dermatitis 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 60 人开始时间: 2019年2月13日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Patient Oriented Score of Atopic Dermatitis (PO-SCORAD)

研究概览

简要总结

Atopic Dermatitis (AD) is a chronic, relapsing, pruritic, inflammatory skin disease having significant impact on the quality of life (QoL) and public health costs. Despite the fact that the evidences favouring homeopathy in AD is unconvincing, and based mostly on experience or anecdotal data, it is still highly popular. We evaluated whether individualized homeopathic medicines (IH) have significant effect beyond placebo in treatment of AD. A double-blind, randomized (1:1), two parallel arms, placebo-controlled trial (n=60) was conducted at D. N. De Homoeopathic Medical College and Hospital, West Bengal. Primary outcomes were patient-oriented scoring of AD (PO-SCORAD); secondary outcomes were dermatological life quality index (DLQI), and AD burden score for adults (ADBSA); measured at baseline, and every month, up to 3 months. Effect sizes (Cohen’s d, means adjusted for differences of baseline values) were calculated on intention-to-treat sample to detect group differences. Nine patients dropped out (IH: 3, Placebo: 6). Though intra-group changes were significant, between-group differences in PO-SCORAD, DLQI and ADBSA scores were non-significant (all P > 0.05, unpaired t test) except DLQI at month 1 (mean difference 1.3, 95% confidence interval (CI) 0.2 to 2.2, P = 0.019, unpaired t test, Cohen’s d = 0.6). Group difference on DLQI after 3 months (mean difference 1.9, 95% CI -0.1 to 3.9, P = 0.064, unpaired t test, Cohen’s d = 0.5) was near significant. Although the improvements produced by IH were higher than placebo, group differences were mostly non-significant. The trial being underpowered and of short duration, cautious interpretation is necessary.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • Patients of 18-65 yrs of age
  • Both sexes
  • Suffering from atopic dermatitis as per UK diagnostic criteria for atopic dermatitis and POSCORAD more than 10
  • Patients already undergoing treatment for atopic dermatitis may be recruited on completely stopping medicine and after wash-out phase of 1 month
  • Literate patients
  • Signed written informed consent to participate.

排除标准

  • Patients too sick for consultation
  • Diagnosed case of unstable or psychiatric illness affecting quality of life (QoL)
  • Uncontrolled or life-threatening illness affecting QoL or any organ failure
  • Substance abuse and/or dependence
  • Pregnant and lactating women
  • Undergoing homoeopathic treatment for any chronic disease within last 6 months.

结局指标

主要结局

Patient Oriented Score of Atopic Dermatitis (PO-SCORAD)

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

次要结局

  • Dermatology Life Quality Index (DLQI)(At baseline, and every month up to 3 months)
  • Atopic Dermatitis Burden Scale for Adults (ADBSA)(At baseline, and 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

研究点 (1)

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