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临床试验/CTRI/2020/10/028623
CTRI/2020/10/028623已完成2/3 期

Double-blind, randomized, placebo-controlled, pilot trial of individualized homoeopathic medicines in perennial allergic rhinitis

The Calcutta 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: 2020年10月26日最近更新:
适应症

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Juniper Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ)

研究概览

简要总结

Perennial allergic rhinitis (PAR) is characterized by sneezing, rhinorrhoea, nasal stuffiness, and conjunctival, nasal, and pharyngeal itching and lacrimation, resulting from exposure to allergens throughout the year. An increasing prevalence of PAR has also been reported in India. Homeopathy is claimed to be beneficial in PAR, but evidence remains scarce. In this trial, the efficacy of individualized homeopathic medicines (IHMs) was compared against placebos in the treatment of PAR. This 3-month, double-blind, randomized (1:1), placebo-controlled trial was conducted at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital, Kolkata with 60 participants with PAR. Each of the participants received either IHMs or identical-looking placebos, along with concomitant care. The primary outcome measure was Juniper’s rhino-conjunctivitis quality-of-life questionnaire (RQLQ); secondary outcome measures were visual analog scales (VAS) measuring symptom severities, all measured at baseline, and after 3 months. Group differences were calculated on the intention-to-treat sample. The significance level was set at p less than 0.05, two-tailed. Between-group differences in RQLQ total (mean difference: 29.5, 95% CI 18.9 to 40.0, p < 0.001), total nasal symptom severity VAS (mean difference 17.8, 95% CI 11.5 to 24.1, p < 0.001), non-nasal eye symptom VAS (mean difference: 9.3, 95% CI 1.0 to 17.7, p = 0.029), non-nasal mental symptom severity VAS (mean difference: 16.1, 95% CI 1.0 to 22.2, p < 0.001), global assessment VAS (mean difference: 20.5, 95% CI 14.2 to 26.9, p < 0.001), and QoL VAS (mean difference: 20.3, 95% CI 14.4 to 26.1, p < 0.001) were statistically significant favoring IHMs against placebos, with large effect sizes. Tuberculinum bovinum and Natrum muriaticum were the most frequently prescribed medicines. No serious adverse events were reported from either of the groups. Thus, IHMs performed significantly better than placebos in the treatment of PAR.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • •Age 18-65 years and of either sex
  • •Cases suffering from allergic rhinitis (2020 ICD-10-CM Diagnosis Code J30.89) – persistent and perennial variety and of moderate intensity for more than 1 year
  • •Atopic: reactive to inhaled allergens
  • •Literate patients; can read Bengali and/or English
  • •Providing written informed consent to participate in the trial.

排除标准

  • •Nasal abnormalities causing obstruction; e.g. nasal polyps, deviated septum
  • •Allergen avoidance in past 6 weeks
  • •Away from usual environment for more than 1 week during trial
  • •Respiratory infections
  • •Patients with risk of developing bronchial asthma
  • •Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life
  • •Patients who are too sick for consultation
  • •Pregnant and puerperal women, and lactating mothers
  • •Substance abuse and/or dependence
  • •Self-reported immune-compromised state
  • •Oral or parenteral steroids in past 6 months
  • •Conventional desensitization in past 6 months
  • •Previous homoeopathic immunotherapy for perennial AR
  • •Undergoing homoeopathic treatment for any chronic disease within last 6 months.

结局指标

主要结局

Juniper Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ)

时间窗: At baseline and after 3 months

次要结局

  • Visual analogue scale (VAS) measures of nasal, non-nasal and global severity and quality of life (QoL)(At baseline and after 3 months)

研究者

发起方
The Calcutta Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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