Randomized Controlled Trial Of Bhrushakshav Taila Pratimarsha Nasya in Vataj Pratishayaya with special reference to Allergic Rhinitis.

Title-Randomized Controlled Trial Of Bhrushakshav Taila Pratimarsha Nasya in Vataj Pratishayaya with special reference to Allergic Rhinitis.

Acharya Sushruta detailed 31 Nasagata Roga in Sushruta Samhita Uttartantra. Within this, Pratishyaya is identified as one of the Nasagata Roga with Acharya Sushruta dedicating a separate chapter in Uttara Tantra specifically to Pratishyaya Pratishedho Adhyaya. This ailment is further categorized into five types, namely Vataja, Pittaja, Kaphaja, Raktja, and Sannipataja.  Notably, Vataja Pratishyaya is considered a Vata Pradhana Tridoshaja Vikara. Failure to adequately manage Pratishyaya may result in the development of a severe and complex condition known as Dushta Pratishyaya chronic sinusitis.Various Acharayas have described the defining characteristics of Vataja Pratishyaya in different texts.

In today’s era, On reviewing the clinical presentation of Vataja Pratishyaya nearly simulates with the disease Allergic rhinitis. Allergic rhinitis is certainly one of the prime diseases of Rhinology. Allergic rhinitis is an allergic response of nasal mucosa to air-borne allergen and it is characterised by sneezing, itching in the nose, watery nasal discharge and nasal obstruction. This may also be associated with symptoms of itching in the eyes, palate and pharynx. According to World Allergy Organization it is estimated that 400 million people suffer from allergic rhinitis across the world. The prevalence of AR has slightly escalated currently approximately 10 to 15 percent of adults and 40 percent of adults and 40 percent of children’s are affected. In India the prevalence of AR 11.3 percent .Long time use of modern drugs i.e., oral antihistamines, which are used in allergic rhinitis has been limited due to sedative effect. Local irritation and epistaxis are the most frequent side effects of nasal corticosteroid. Intra-arterial injection of steroid into the inferior turbinate runs the risk of inducing blindness.Oral decongestants are beneficial in short term treatment but can have significant side effects such as hypertension, nervousness, insomnia, irritability and long term usage of nasal decongestants, causes Rhinitis Medicamentosa .

Ayurveda plays important role in it with minimum side effect and better compliance.Nasya is mentioned as one of the Upkrama of Dincharya. In charak samhita it has been mentioned that by doing Nasya helps in treating  pratishaya.Nasya done with oil medicated by drug having vatakaphahara and shodhana property helps in breaking samprapti of pratishaya. According to Ashatang hrudaya, Bhrushakshav taila is mentioned have vata kaphaghna in properties. All drugs suntha, kushta, pippali, vayavidang, manukka are easilyavailable and cost effective. Nasya is beneficial in pratishaya. This treatment is very cost effective as a drug used in this is very cheap and easily available so every person can purchase, including poor class people.

Thus, the need of the hour is a safe and effective treatment for controlling pratishaya. The present study has been undertaken to manage the condition of Pratishaya by Nasya treatment- which is one of the choice of management for its prime role in treating and preventing Pratishaya. According to Ashtang Hrudaya, Bhrushakshav Oil Nasya in indicated in Bhrushakshav Recurrent Shavathu which is also one of symptom of Vataj Pratishaya having same affected organ nasa. That’s why this study is aimed to foresee the effect of Bhrushakshav taila Pratimarsha Nasya in vataj Pratishaya. The present study has been undertaken to manage the condition of Vataj Pratishaya by Nasya- which is one of the choice of management for its prime role in preventing and treating Vataj Pratishaya.

AIM:-To study the effect of Bhrushakshav Taila Pratimarsha Nasya in Vataj Pratishaya with special reference to Allergic Rhinitis.

OBJECTIVES:-

Primary Objectives:-

1.To study the effect of Bhrushakshav Taila Pratimarsha Nasya in Vataj Pratishaya with special reference to Allergic Rhinitis.

2.To study the effect of Anu Taila Pratimarsha Nasya in Vataj Pratishaya with special reference to Allergic Rhinitis.

3.To compare the effect of Brushakshav Taila Pratimarsha Nasya and Anu Taila Pratimarsha Nasya in Vataj Pratishaya with special reference to Allergic Rhinitis.

Secondary Objectives:-

1. To prepare Brushakshav Taila

2. To study the literature about Vataj Pratishyaya according to Ayurveda and Modem science.

3. To study the literature of Shunthi, Kushta, Vidanga, Draksha, Pippali, Til Taila in Ayurveda and Modern science.

4. To study the safety of Bhrushakshav Taila.

Screening of the subjects from population will be done on the basis of Inclusive criteria and exclusive criteria.

They will be divided into two groups randomly by computerised random sampling method after taking consent.

Sampling method -A consecutive sample of 64 subjects who are seeking treatment and care at the study hospital, who consent to participate in the study and who fulfil the eligibility (inclusion and exclusion) criteria will be selected by convenience sampling method from the study setting i.e. hospital

Randomization-The selected sample of 64 subjects will be first randomly allocated to two intervention (main groups) using Simple block randomization method. A predetermined, computer generated random allocation plan will be utilised wherein 16 blocks of size 4 each will be used for equal assignment of subjects in to two intervention (main) groups.

Blinding - There will be no blind in this randomized controlled trial, both subjects and

Method of selection of study-investigator will not be blind to treatment assignment.

Subjects-

Inclusion criteria:

1.Individuals having symptoms of Vataj Pratishaya.

2. Age Group-18-40 years.

3. Irrespective of sex, education, religion and socio economical status,

4. Individuals having allergic Rhinitis within 3 years.

5. Individuals willing for regular follow up.

6. Individuals Having TNSS score 6 morethan equal to 6.

Exclusion criteria:

1. Subjects having any systemic diseases.

2. ANC and PNC female.

3. Individuals having COPD, Emphysema, conditions like Status Asthmaticus,

4. Patient unfit for Pratimarsha Nasya.

5. Non co-operative patient for the study.

Withdrawal criteria:

Subject who develop any unwanted symptoms during the study.

Subject who unable to give follow up

Assessment Criteria

Subjective parameters

Based on sign & Symptoms of Allergic Rhinitis " Total Nasal Symptoms

Score 12

1. Nasal obstruction Nasa avrodh

2. Rhinorrhea Nasastrav

3. Nasal itching Nasa kandu

4. Sneezing kshwathu

Objective Parameters   Eosinophil count (CBC)

Parameters for assessment of study outcomes

Overall Effect of Therapy Overall Assessment Criteria

Overall assessment will be done by following -

1. Not cured - No improvement in subjective Criteria

2. Improved - Improvement in Subjective criteria

3. Cured - Improvement in Subjective criteria

Efficacy of Treatment through Nasya

Total NasalScore Grade-12

Total assessment

Excellent 0 100% Relief in sign & symptoms

Very mild 1-3 75-99% Relief in sign & symptoms

Mild 4-6 50-75% Relief in sign & symptoms

Moderate 7-9 25-50% Relief in sign & symptoms

Severe Infective 10-12 0-25% Relief in sign & symptoms.

Total Nasal Symptoms Score TNSS Minimum Score - 0

Maximum Score -12