跳至主要内容
临床试验/CTRI/2025/09/094261
CTRI/2025/09/094261尚未招募2/3 期

The effectiveness of Histaminum hydrochloricum in allergic rhinitis: a clinical verification study

DR Riddhi Shah1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
38
试验地点
1
主要终点
Acute Rhinitis Symptom Score (ARSS)

研究概览

简要总结

Allergic rhinitis (AR) is a chronic IgE-mediated hypersensitivity disorder triggered by environmental allergens such as dust, pollen, and animal dander, affecting nearly 20–30% of the Indian population. Despite being non-fatal, AR significantly impairs quality of life through sleep disturbances, fatigue, and reduced productivity. Conventional treatments, including antihistamines and corticosteroids, offer only temporary relief and may cause adverse effects. Homeopathy provides a holistic approach, and Histaminum hydrochloricum, a preparation derived from histamine, has shown promise in allergic conditions but remains under-researched in AR. The present study aims to clinically verify its effectiveness in allergic rhinitis. An interventional, uncontrolled clinical trial will be conducted at Smt. S. I. Patel Homoeopathic Hospital, Anand, over 9 months. Eighty patients will be screened, and 38 eligible participants (aged 10–80 years) will be enrolled using purposive sampling. Treatment will be individualized according to homeopathic principles, with potency adjusted to patient susceptibility. Outcomes will be assessed using Score for Allergic Rhinitis (SFAR), Acute Rhinitis Symptom Score (ARSS), and laboratory parameters (IgE, CBC, AEC) at baseline and follow-up. Data will be analyzed using paired t-test to compare pre- and post-treatment scores. The study seeks to provide systematic clinical evidence on the role of Histaminum hydrochloricum in managing AR, bridging clinical practice with evidence-based validation.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
10.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient 10-80 years will be screened irrespective of gender.
  • The cases with Allergic Rhinitis where Histaminum hydrochloricum is indicated will be included.
  • Only those participants who willingly give informed consent will be enrolled in the study.
  • They will be expected to adhere to the prescribed homoeopathic treatment protocol.

排除标准

  • Pregnant or Breast-feeding female will not participate due to hormonal fluctuations.
  • Cases with nasal polyp, Sinusitis, Adenoid Hypertrophy will be excluded.

结局指标

主要结局

Acute Rhinitis Symptom Score (ARSS)

时间窗: Follow up at every 2 weeks and At the End of | treatment as per the requirements of the case

次要结局

  • S.IgE(ESR)

研究者

发起方
DR Riddhi Shah
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR SONAL PANCHMATIYA

Dr V H Dave Homoeopathic Medical College, Anand

研究点 (1)

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