Protocol for a Cross-Sectional Study to Validate the Role of Viharaja Hetu in Pratishyaya Through Questionnaire Development

Introduction

Pratishyaya is a frequently occurring respiratory condition, affecting individuals across all age groups and both genders. Although it is often self-limiting, if left untreated or inadequately managed, it can lead to serious complications such as Kasa, Kshaya, and Rajyakshma. Classical Ayurveda texts, particularly the Caraka Samhita, regard Pratishyaya as a nidanarthak (disease-inducing) disorder of Kasa (cough) and as a precursor (purvaroop) to Rajyakshma (tuberculosis), highlighting its significant role in the pathogenesis of more severe conditions.

In Ayurveda, the emergence of Pratishyaya is strongly linked to lifestyle factors, known as Viharaja hetu, which include exposure to extreme temperatures, allergens, irregular daily routines, and the suppression of natural urges. These factors are believed to disrupt the balance of the Vata and Kapha doshas, contributing to the onset and exacerbation of the condition. Nidan parivarjan—the avoidance of causative factors—is a fundamental approach in Ayurveda medicine for both the prevention and management of Pratishyaya.

This study aims to design and validate a comprehensive questionnaire to evaluate the role of Viharaja hetu in the development of Pratishyaya. By developing a standardized tool, the study seeks to enhance our understanding of the lifestyle-related risk factors that contribute to this condition, thereby promoting better preventive strategies and management based on Ayurveda principles.

Table: 1 : Viharaja Hetu for Pratishyaya According to Various Acharya

Aim and Objectives

Aim:

To develop and validate a questionnaire for assessing the role of Viharaja hetu as a risk factor in Pratishyaya.

Objectives:

1. To design and validate a comprehensive questionnaire for assessing Viharaja hetu.
2. To validate the questionnaire with the help of subject experts.

Research Question

What is the role of Viharaja hetu in the pathogenesis of Pratishyaya, and how can it be assessed effectively using a validated tool?

Hypothesis

Null Hypothesis (H₀): The designed questionnaire does not significantly assess the role of Viharaja hetu in Pratishyaya.

Alternate Hypothesis (Hₐ): The designed questionnaire significantly assesses the role of Viharaja hetu in Pratishyaya.

Materials and Methods

Study Design:

A cross-sectional study focused on questionnaire development and validation.

Sources of Data:

1. Clinical Source: Participants will be recruited from the college campus to validate the questionnaire.
2. Literary Source: Classical Ayurveda texts like Carakasamhita, Sushrutasamhita, Ashtangahridayam, Ashtangasangraha, Madhavnidana, Yogratnakara, Kashyapasamhita, commentaries, modern literature, research articles, and online portals.

Methodology:

1. Literature Review:

An extensive review of classical Ayurveda texts like Carakasamhita, Sushrutasamhita, Ashtangahridayam,  Ashtangasangraha, Madhavanidana, Yogratnakara,  Kashyapasamhita, modern literature, and research articles to identify Viharaja hetu contributing to Pratishyaya.  

2. Questionnaire Design:

• A 5-point Likert-scale questionnaire will be prepared, addressing key Viharaja hetu identified from the literature.
• The questionnaire will include questions related to lifestyle factors such as exposure to extreme temperatures, irregular routines, suppression of natural urges, and environmental conditions.

3. Validation of the Questionnaire:

• Expert Review: 10 Subject experts will review the questionnaire to ensure content validity.
• Focal group discussions with experts in Ayurveda will refine the questionnaire by suggesting corrections till validation.
• Pre-testing and Reliability Testing: The validated questionnaire will be distributed to selected participants.
• Statistical tools will be used to assess reliability and consistency. Chi-square test for association and Mann Whitney U test for differentiation will be applied.

4. Data Collection and Analysis:

• Responses will be collected through Google Forms .
• Statistical analysis will determine the effectiveness of the questionnaire in assessing Viharaja hetu. Chi-square test for association and Mann Whitney U test for differentiation will be applied.

Inclusion Criteria:

1. Participants aged 18–60 years, irrespective of gender, caste, or socio-economic status.
2. Participants willing to provide informed consent for the study.

Exclusion Criteria:

1. Structural abnormalities like deviated nasal septum, nasal polyps, or sinusitis.
2. Functional abnormalities like smell and taste disorders.
3. Infectious diseases like tuberculosis and systemic diseases like bronchial asthma.
4. Participants below 18 years or above 60 years.
5. Participants unwilling to participate.

Materials Required:

1. Ayurveda classical texts and commentaries.
2. Questionnaire designed on Viharaja hetu.
3. Statistical tools for validation and reliability testing.

Data Analysis

• The responses to the questionnaire will be analyzed using statistical methods, such as Cronbach’s alpha for reliability and factor analysis for validation.
• Results will help establish the questionnaire as a standardized tool for assessing Viharaja hetu in Pratishyaya.

Anticipated Outcomes:

1. A validated questionnaire for assessing the role of Viharaja hetu in Pratishyaya.
2. Identification of key lifestyle-related risk factors contributing to the disease.
3. Insights into preventive measures aligned with Ayurveda principles.

Expected outcomes:

Primary Outcomes:

1. Development and validation of a reliable, standardized questionnaire to assess Viharaja hetu in the pathogenesis of Pratishyaya.
2. Systematic identification and categorization of significant Viharaja hetus contributing to the onset and progression of Pratishyaya, based on classical Ayurveda texts and expert inputs.

Secondary Outcomes:

1. Creation of a practical assessment tool for clinicians to evaluate lifestyle-related risk factors and their role in Pratishyaya, aiding in preventive care strategies.
2. Strengthening the scientific foundation of Ayurveda principles by integrating classical knowledge with modern research methods through questionnaire validation.
3. Promoting awareness among patients and the general public about the importance of avoiding Viharaja hetu and adopting healthier lifestyle practices to prevent Pratishyaya and its complications.

Significance of the Study:

This study emphasizes the importance of lifestyle factors (Viharaja hetu) in the development of Pratishyaya. By developing a validated questionnaire, it bridges the gap between theoretical understanding and practical assessment, aiding in better disease prevention and management strategies.

Table 2: Timeline of the Proposed Research Work

Funding and Conflicts of Interest:
No external funding was received for this study. The authors declare no conflicts of interest.

References:

[1]Carakasamhita, Nidanasthana, Apsamaranidanaadhyaya, 8/19. Available from https://niimh.nic.in/ebooks/ecaraka/?mod=read (accessed on 11 January 2025)

[2]Carakasamhita, Chikitsasthana, Rajyakshmachikitasitamadhyaya, 8/33-37. Available from https://niimh.nic.in/ebooks/ecaraka/?mod=read (accessed on 11 January 2025)

 [3]Sushrutasamhita, Uttartantra, Pratishyayapratishedhaadhyaya, 24/3. Available from https://niimh.nic.in/ebooks/esushruta/?mod=read  (accessed on 11 January 2025)

[4]Carakasamhita, Chikitsasthana, Rajyakshmachikitasitamadhyaya, 8/33-37. Available from  https://niimh.nic.in/ebooks/ecaraka/?mod=read  (accessed on 11 January 2025)

[5] Carakasamhita, Chikitsasthana, Rajyakshmachikitasitamadhaya, 8/48-50. Available from https://niimh.nic.in/ebooks/ecaraka/?mod=read   (accessed on 11 January 2025)

[6]Carakaa Samhita, Nidanasthana, Apsamaranidanaadhaya, 8/19. Available from https://niimh.nic.in/ebooks/ecaraka/?mod=read  (accessed on 11 January 2025)

[7]Carakasamhita, Chikitsasthana, Trimarmiyachikitsitamadhyaya, 26/104. Available from https://niimh.nic.in/ebooks/ecaraka/?mod=read (accessed on 11 January 2025)

[8] Carakasamhita, Sutrasthana, Navegandharniyaadhyaya, 7/22. Available from https://niimh.nic.in/ebooks/ecaraka/?mod=read (accessed on 11 January 2025)

[9]Sushrutasamhita, Uttartantra, Pratishyayapratishedhaadhyaya, 24/3. Available from https://niimh.nic.in/ebooks/esushruta/?mod=read   (accessed on 11 January 2025)

[10] Ashtangahridayam, Uttarsthana, Nasarogavigyaniyamadhyaya, 19/1-2. Available from https://vedotpatti.in/samhita/Vag/ehrudayam/?mod=read (accessed on 11 January 2025)

[11]Ashtangasangraha, Uttarsthana, Nasarogavigyaniyaadhyaya,  23/2. Available from https://vedotpatti.in/samhita/Vag/esangraha/?mod=read (accessed on 11 January 2025)

[12]Madhav Nidana, Nasaroganidanamadhyaya 58/13-14. Available from https://niimh.nic.in/ebooks/madhavanidana/?mod=read (accessed on 11 January 2025)

[13] Proff. Mishra SN Yogaratnakar (Hindi) Varanasi: Chaukhamba Orientalia 65/17 pg 919.

[14]Tripathi SI, Pandeya GS, Gadanigraha of Sri Vaidya Sodhala (Hindi) Varanasi: ChaukhambaSanskrit Sansthan , Vol 3 , Shalkyatantra 4/13-14 pg 181.

[15]Carakasamhita, Chikitsasthana, rajyakshmachikitasitam, 8/48-50. Available from https://niimh.nic.in/ebooks/ecaraka/?mod=read   (accessed on 11 January 2025)

[16] A Clinical study of haridrakhand and pippalyadi tailam nasya on pratishyaya, Year-2010, AuthorChhaya bhakti, Manjusha Rajgopala, AK Shah,Narayan Bavalatti.

[17] Bhishakacharya S, Kashyapsamhita of Vriddha Jivaka (Hindi) Varanasi: – Chaukhambha SanskritSansthan , Ka. Ch. Khanditadhyaya Pratishayaychikitsamadhyaya/3 pg 193.