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Clinical Trials/CTRI/2024/12/078578
CTRI/2024/12/078578
Not yet recruiting
Phase 2/3

A Comparative Clinical Trial to Study the Effect of Shigru Taila Nasya and Anu Taila Nasya in management of Vataja Pratishaya (Allergic Rhinitis)

Smt K C Ajmera Ayurved Mahavidyalya DeopurDhule1 site in 1 country70 target enrollmentStarted: January 13, 2025Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Smt K C Ajmera Ayurved Mahavidyalya DeopurDhule
Enrollment
70
Locations
1
Primary Endpoint
1)Kshavathu (Sneezing) Should Decreased

Overview

Brief Summary

Due to a lot changes in this modern era, as changes have come in life style, living habits, pollution, and environmental changes, people are getting more affected to disease, due to their weak immune system, which causes disturbed in routine life-style

In this 21st generation people are more prone to allergic disease due to environmental changes, lifestyle changes and pollution disease like dryness of eyes, allergic bronchitis, allergic skin diseases and allergic rhinitis. Allergic reaction is produced when the body comes in contact with allergens little dust, dander, pollens then certain chemicals are produced in the body called histamines which releases into the blood stream and produces symptoms like excess mucus production, swelling of affected tissues, itching, sneezing, rashes Modern science described allergic disease in detail considering an allergens little dust, dander, pollens are cause for allergic disease.

The disorder of Nasa has been described widely by all acharyas; Acharya Sushrut had described Nasa Gatha Rogas among them Pratishyaya is one of the most important diseases.

Allergic rhinitis has symptoms like Watery nasal discharge, Sneezing, Itching in the nose, Runny nose, Watery eyes, Nasal congestion, Stuffy nose, Redness, Headache, Throat irritation,

Vataja Pratishyaya can be correlated to allergic rhinitis because most of the signs and symptoms such as Nasagata Tanustrava (Watery nasal discharge), Kshavathu (sneezing) and Nasaavarodha (Nasal obstruction), Shirogaurav (Headache), Kandu (Itching in nose & eye) are similar as found in Vataja Pratishaya.

As per Charakacharya, Nasya is explained at Matrashitiya adhyay.11 Nasya is administrated in nasal cavity by drop.

पिबेव्दातप्रततशाये सपििर्ाितघ्नसाधितम ।

िटुिंचकससध्दं र्ा पर्दयािददगणेन र्ा।

स्र्ेदनस्याददकां कुयािच्चचककत्सामददितोददताम॥

अ.हृ.उ.२०/९-१

The treatment of Vataja Pratishaya is Vatashaman, specially Vataghna dravya, Nasya karma, Grutha prepared can be used 13 from these principles we are going to use Nasya karma, Nasya has significant role of Urdvajatrugata roga hence research will focus on administration of Nasya.

According to Ayurvedic text Shigru Taila nasya in Pratishyaya.

सशग्रुकान्तार्चाव्योषद्राक्षासुरससैन्िर्ैैः ।

नस्यदानाज्जयेच्स्तद्िं तैलं नासागदे नृणाम् ।। र्ंगसेन

As Pratishyaya is Vaat and Kapha dominance disease, and in Vataja pratishyaya ,Vaat is the main dosha. And Shigru Taila having contents which are predominantly Vatakaphashamak Shigru Taila will be used according to reference of Vangasen

Nasya karma is the main therapeutic measure of Urdhvajatrugata roga Nasya with Shigru Taila will provide proper relief from symptoms like Running Nose, Sneezing, Blockage, Headache, itching etc.

I. Null hypothesis (H0)

Effect of Shigru taila Nasya is not significant than Anu Taila Nasya in management of Vataja Pratishyaya (Allergic Rhinitis).

II. Alternate Hypothesis (H1)

Effect of Shigru taila Nasya is significant than Anu Taila Nasya in management of Vataja Pratishyaya (Allergic Rhinitis).

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 1.Patients Of age group 20 years to 60 years will be selected for study 2.Both male and female, patients having classical signs and symptoms of Vataja Pratishyaya (Allergic Rhinitis) irrespective of their socioeconomic status, educational status, caste and religion.
  • 3.Patient who will fullfill the diagnostic criteria of Vataja Pratishyaya.
  • Nasya Arha.

Exclusion Criteria

  • 1 Patients below age group of 20 years and above 60 years.
  • 2 Patient Having previous history of nasal surgery.
  • 3 Patients suffering from nasal polyp, nasal carcinoma, DNS, history of nose trauma.
  • 4 Patients with previous history of head trauma, Intracranial surgery.
  • 5 Pregnant women, Sutika (women in post-natal care) 6 Patients taking any kind of medicine like Corticosteroids, antihistamine, anti-inflammatory, topical corticosteroid.
  • 7 Patients with any major systemic illness 8 Patients with history of alcohol or substance abuse.
  • 9 Patients having history of any Autoimmune Disease.

Outcomes

Primary Outcomes

1)Kshavathu (Sneezing) Should Decreased

Time Frame: 21 DAYS

2)Tanusrav (Runny Nose)Should Decreased

Time Frame: 21 DAYS

3)Aanadhava (Nasal Blockage)Should Decreased

Time Frame: 21 DAYS

4)Shirashool (Headache) Should Decreased

Time Frame: 21 DAYS

Secondary Outcomes

  • 1) Galashotha (Dryness of throat)Should Decreased(2) Nistodhankha (Pricking Pain in Temporal Region) Should Decreased)

Investigators

Sponsor
Smt K C Ajmera Ayurved Mahavidyalya DeopurDhule
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Vaibhav Vishnu Shinde

Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule

Study Sites (1)

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