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临床试验/CTRI/2025/05/086243
CTRI/2025/05/086243尚未招募不适用

Effect of Gudaardrak nasya in the Management of Vataja Pratishyaya with special reference to Allergic Rhinitis A Randomised Controlled Clinical Trial

Dr Adeeb A1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
104
试验地点
1
主要终点
Changes in reduction of prstishyaya lakshana like Nasavarodha Nasasrava Kshavathu Shirashoola Toda in Nasa Akshi Gala and Talu Kandu in Nasa Akshi Gala and Talu

研究概览

简要总结

Title:Evaluation of Gudaardrak Nasya and Internal Gudaardrak in the Management of Vataja Pratishyaya (with special reference to Allergic Rhinitis) in Comparison with Rasanjanadi Taila Nasya

Introduction -Allergic Rhinitis (AR) is an IgE-mediated chronic inflammatory condition of the nasal mucosa, affecting a large global population and significantly impairing quality of life. It is linked with complications such as sinusitis, asthma, and turbinate hypertrophy. Modern treatments provide symptomatic relief but often lead to side effects like mucosal atrophy or sedation. Ayurveda identifies AR with Vataja Pratishyaya, a subtype of Nasagata Roga. Among the treatments, Nasya Karma is highlighted as a prime modality to eliminate Doshas from Urdhvajatru regions. Gudaardrak (a combination of jaggery and ginger) is cited in Ayurvedic texts for its Vata-Kapha hara and mucolytic actions. It is hypothesized that the synergistic use of Gudaardrak Nasya along with internal administration may provide effective relief in Vataja Pratishyaya. This study aims to evaluate and compare the efficacy of this approach with Rasanjanadi Taila Nasya, a classical formulation.

Methodology****Study Design: Randomized Controlled Clinical Trial Site: KAHER’s Shri B M K Ayurveda Mahavidyalaya, Belagavi Ethics: Approved by Institutional Ethics Committee; CTRI registration to be completed

Population:

  • Inclusion: Adults aged 18–60 diagnosed with Vataja Pratishyaya, with Grade 1 DNS, and willing for Nasya
  • Exclusion: Nasal polyps, tumors, acute URTI, or systemic disorders

Sample Size: 52 participants in each group

  • Group A (Trial): Gudaardrak Nasya for 7 days (2 sittings) + Gudaardrak internally for 30 days
  • Group B (Control): Rasanjanadi Taila Nasya for 7 days + Gudaardrak internally for 30 days

Dosage:

  • Nasya: 6 drops bilaterally

  • Internal: 1 Karsha (12 gm/day) in divided doses

  • Assessment:

  • Days: 1 (Baseline), 30 (Post-treatment), 60 (Follow-up)

  • Parameters: Nasal discharge, blockage, sneezing, headache, itching and pricking pain in nose, eyes, throat, and palate

  • Laboratory: AEC (Absolute Eosinophil Count)Statistical Tools:

  • Descriptive stats, Chi-square, Mann-Whitney U-test, Wilcoxon matched pairs test, Student’s t-test

  • Significance level: p < 0.05

  • Conclusion-  use of Gudaardrak Nasya and internal Gudaardrak may offer significant relief in symptoms of Vataja Pratishyaya, potentially positioning it as a reliable and side-effect-free alternative in the Ayurvedic management of Allergic Rhinitis.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Subjects fulfilling the diagnostic criteria of Vataja Pratishyaya (Allergic Rhinitis) Subjects fit for Nasya karma Subjects with signs & symptoms of Vataja Pratishyaya ,who are willing to enrol in the study by giving written consent.

排除标准

  • •Nasal polyps (anterior rhinoscopy & probe test ) Any abnormal nasal growth like Rhinoporidiosis, Rhinolith Epistaxis D.N.S. grade 1 (with anterior rhinoscopy) Tumours of the nose Acute Upper respiratory tract infection.
  • •Other Systemic Disorders like Tuberculosis, Leprosy, uncontrolled DM and hypertension.

结局指标

主要结局

Changes in reduction of prstishyaya lakshana like Nasavarodha Nasasrava Kshavathu Shirashoola Toda in Nasa Akshi Gala and Talu Kandu in Nasa Akshi Gala and Talu

时间窗: 1st day Before treatment 30th day after treatment and 60th day follow up

次要结局

  • Changes in AEC(Baseline 1st day to 30th day after tretament)

研究者

发起方
Dr Adeeb A
申办方类型
Other [PhD Thesis]

研究点 (1)

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