跳至主要内容
临床试验/CTRI/2024/03/064405
CTRI/2024/03/064405
尚未招募
2/3 期

Effect of Manual Acupressure as a Supplementary Therapy on Quality of Life in Patients of Allergic Rhinitis; a Randomised Controlled Trial

JIPMER Intramural Research Fund1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年3月27日最近更新:

概览

阶段
2/3 期
状态
尚未招募
发起方
JIPMER Intramural Research Fund
入组人数
80
试验地点
1
主要终点
Improvement in scores of quality of life questionnaires: NRQLQ, VAS, TNSS

概览

简要总结

Acupressure is a simple, non-invasive and self-administered modality of treatment which has been explored in the management of various conditions with varying degrees of success.

Studying the efficacy of acupressure as an adjunctive therapy in allergic rhinitis could open the door to its integration into the existing treatment rationale, subsequently reducing the disease burden and improving quality of life and productivity, especially among the working population. As of now, there are few studies of good quality in this field, and none of those are from India.

Expected Outcome: Improvement in quality of life, and reduction in symptoms, as reflected by questionnaire scores, in patients employing self-administered manual acupressure in addition to standard therapy.

After randomization and allocation, patients belonging to the Standard Therapy Only (STO) group will be provided with oral antihistamines (Cetirizine 10mg HS) and inhaled corticosteroid (Fluticasone plus Azelastine nasal spray 1 puff in each nostril twice daily) prescriptions.

Patients belonging to Manual Acupressure (MAP) group will be given oral antihistamines and inhalational corticosteroid. In addition, they will receive an individual hands-on demonstration,lasting 20 to 30 minutes,of acupressure points and technique for self-administration of acupressure, as well as a video demonstrating the same to them for domestic use. This is to be self-administered for 20 minutes every day, applying enough pressure so as to not cause pain.

After the baseline measurements, outcomes will be measured at 4 weeks and 6 weeks, during in-person follow-up visit. This will be done using standardized validated questionnaires i.e, Nocturnal Rhinitis Quality of Life Questionnaire (NRQLQ), Visual Analogue Score (VAS) and Total Nasal Symptom Score (TNSS).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Between the ages of 18 and 50 years
  • Clinically diagnosed as allergic rhinitis, as per ARIA guidelines and using Absolute Eosinophil Count
  • Symptom duration for more than 6 months
  • Moderate to severe allergic rhinitis (Visual Analogue Scale score of 30-70mm at baseline)
  • Symptoms severe enough to require oral antihistamines/intranasal corticosteroid usage.

排除标准

  • Pediatric patients, less than 18 years of age
  • Patients with anatomical abnormality of nose (Deviated nasal septum, Concha bullosa etc)
  • Patients with diagnosed asthma or other chronic upper respiratory pathologies, parasitic infestations or immunological diseases
  • Pregnant and breastfeeding women
  • Patients on steroids or other immunosuppressive therapy for unrelated conditions
  • Patients using other complementary medicine systems during the study period
  • Contra-indication to cetirizine or inhalational steroid therapy.

结局指标

主要结局

Improvement in scores of quality of life questionnaires: NRQLQ, VAS, TNSS

时间窗: Improvement in scores of quality of life questionnaires: NRQLQ, VAS, TNSS at baseline, 4 weeks and 6 weeks

次要结局

  • Reduction in total serum human immunoglobulin E (IgE)(6 weeks)

研究者

发起方
JIPMER Intramural Research Fund
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shreyaa Sampath Kumar

JIPMER

研究点 (1)

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