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临床试验/CTRI/2024/07/070747
CTRI/2024/07/070747尚未招募2 期

Combined effect of sunthyadi ghritha prathimarsha nasya and vyoshadi vataka internally with honey in allergic rhinitis

Anoopa P P1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
35
试验地点
1
主要终点
Total Nasal Symptom Score (TNSS)

研究概览

简要总结

Allergic rhinitis is an IgE mediated immunologic response of nasal mucosa to airborne allergens and is  characterized by watery nasal discharge, nasal obstruction, sneezing and itching in the nose. Repeated  attack and improper management of the disease lead to many complications like eczema, nasal polyps,  otitis media, asthma, conjunctivitis, sinusitis, migraine etc. Living with chronic allergies can lead to  reduced quality of life and may affect one’s daily activities. Currently, the global prevalence of allergic  rhinitis is approximately 10% to 30% in adults and 40% in children. Approximately 22% of adolescents  currently suffer from allergic rhinitis in India. In Modern medical system, a wide range of intranasal  corticosteroids, antihistamines, leukotriene receptor and decongestants are available. But these drugs give  only symptomatic relief and also are not devoid of adverse effects. So we need such a treatment modality  which has maximum effect and having no complications. The clinical features of Allergic rhinitis shows  similarity with Kshavathu, which is mentioned as a nasaroga in Ayurveda classics. Sunthyadi ghritha nasya is mentioned in Chakradatta in the context of Nasarogadhikara. It includes sundi, kana, kushta,  bilva and draksha. Vyoshadi vataka is an ayurvedic classical formulation mentioned in nasaroga  pratisheda in ashtanga hridaya uttarasthana. Hence this study is designed to find out the combined  effect of sunthyadi ghritha prathimarsha nasya and vyoshadi vataka with honey internally in the  management of allergic rhinitis. Aim of the study is to assess the combined effect of ayurvedic management through prathimarsha nasya with sunthyadi ghritha and vyoshadi vataka with honey internally in allergic rhinitis. This study will be  conducted as a pre and post interventional study in op setting of Government Ayurveda College Kannur.  The study population will be selected on the basis of inclusion and exclusion criteria. Participant will be  given sunthyadi ghritha prathimarsha nasya (0.5ml) and vyoshadi vataka 6gm twice daily internally with  honey for duration 21 days. The follow up will be on 37th day. Assessment will be done using grading of  Total Nasal Symptom Score, absolute eosinophil count(AEC), immunoglobulin E (IgE). Result will be  statically analysed by paired t test and wilcoxon signed rank test.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with allergic rhinitis Patients of age group 15-45 years Participants who are willing to give written informed consent and assent.

排除标准

  • Participants with existing nasal polyp tumors DNS severe dyspnea and sinusitis Known cases of bronchial asthma cardiovascular diseases diabetic mellitus carcinoma AIDS Known cases of bleeding disorders Infective nasal disorders persisting even after 6 month Participants who are already undergoing treatment for any allergic diseases Pregnant and lactating women.

结局指标

主要结局

Total Nasal Symptom Score (TNSS)

时间窗: 37 DAYS

次要结局

  • AEC(Absolute Eosinophil Count)(Serum IgE)

研究者

发起方
Anoopa P P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anoopa P P

Government ayurveda college kannur pariyaram

研究点 (1)

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