A Randomized Clinical Trial on the Role of Shigru Taila Nasya and Gaganesvara Rasa with or without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference To Allergic Rhinitis.

The increasing prevalence of Allergic Rhinitis has affected global health problem effecting a quarter of the world population. Over 400 million people suffer from Allergic Rhinitis around the world and to a large extent it remains under diagnosed and under treated. About 20-30% of  Indian population  suffer from  at least  one  allergic  disease where allergic rhinitis alone constitutes about 55% of all allergies.

Allergic Rhinitis symptoms result in sleep disturbances, fatigue, depressed mood and cognitive functions which impairs quality of life and productivity. Many treatment modalities are explained in Allopathic science like corticosteroids, anti allergic drugs, inhalers, antihistamines etc. but none of them are totally effective in curing the disease as well as preventing its recurrence, more over they have their own side effects. Although innumerable preparations are available in modern science, no drug ensures complete relief without any side effects and the chances of recurrences are relatively high. Hence there is a need for more effective, safe, treatment modality which is especially beneficial in chronic cases to treat this problem from grass root level.

Kostha suddhi is very beneficial for removing the Doshas from the body especially in chronic cases as the Doshas are lodged in different parts of body. Sarvanga Abhyanga and Sweda**nahelp in diverting the Doshas from Shakhas toKoshta which can then can be expelled through Haritakyadi Churna Virechana. Moreover, in Vataja Pratishyaya, as there is Vimarga gamana of Vata Dosha, Virechana does Shareera shodhana and Vata Anulomana and hence it can be beneficial in this disease. Along with that, Nasya Karma is considered as the main Shodhana therapy to expel Doshas from the Shiras.  Hence Shigru Taila Nasya has been selected which is considered as a drug of choice in Vataja Pratishyaya. In order to promote Shamana effect, Gaganesvara rasa is selected for internal administration in patients suffering from Vataja Pratishyaya (Allergic Rhinitis). Hence this study entitled,A Randomized clinicalTrial on the Role of Shigru Taila Nasya and Gaganesvara  Rasa with or without Haritakyadi  churna  Virechana in Vataja Pratishyaya with special reference To  Allergic Rhinitis is selected for providing a better relief without any recurrence in order to find an effective solution to the above problem for curing the disease from its root cause.

Aim and Objectives

Aim

To evaluate the efficacy of Shigru Taila Nasya, Gaganesvara Rasa with and without Haritakyadi Churna Virechana in  Vataja Pratishyaya with special reference to Allergic Rhinitis

Objectives

·         To evaluate the efficacy of Shigru Taila Nasya and Gaganesvara Rasa orally with Haritakyadi Churna Virechana  in Vataja Pratishyaya with special reference to Allergic Rhinitis.

·         To evaluate the efficacy of Shigru Taila Nasya and Gaganesvara Rasa orally without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference to Allergic Rhinitis

Study Medication**:**

Group A - 15 patients of Vataja Pratishyaya will be given Haritakyadi Churna Virechana followed by Shigru Taila Nasya along with internal administration of Gaganesvara Rasa.

Group B – 15 patients of Vataja Pratishyaya will be given Shigru Taila Nasya and internal administration of Gaganesvara Rasa.

·

·       Treatment Plan :

Treatment

Duration

Follow up

|Group- 1

Koshta Shuddi-

Sarvanga Abhyanga and Swedana for one day followed by 6 to 10 gms of Haritakyadi Churna  Virechana  given with luke warm water

Marsha Nasya with Shigru Taila in dosage of 6 drops each nostril

  3 to 7 days as per Koshta shuddhi

  14 days (2 sittings each of 7 days with an interval of 7 days in between).

       Once in 15 days

2 follow ups after treatment

| Gaganesvara Rasa 250 mg b.d. with honey

21 days Starting along with Nasya karma

  |Group- 2

Marsha Nasya with Shigru Taila indosageof 6 drops in each nostril.

14 days (2 sittings each of 7 days with an interval of 7 days in between).

| Gaganesvara Rasa 250 mg b.d. with honey

21 days, starting along with Marsha Nasya.

 Â·         Assessment Criteria: -

To assess the relief  in signs and symptoms mentioned below, a specific scoring pattern  will be adopted.

a. ShirohShoola /Shirogaurava (Headache)

b. Tanusravapravartan (Rhinorrhoea)

c. Kshavathu (Sneezing)

d. Aanaddha Nasa (Nasal obstruction)

e. Swaropaghata  (Hoarseness of voice)

f. Kasa (Cough)

g. Kandu (Itching)

h. Nasal Congestion.

i. Turbinate hypertrophy

 â—       Laboratory Investigations –

Following investigations will be carried out before and after trial.

1.      Absolute Eosinophil Count(AEC)

2.      CBC

3.      ESR

4.      Allergen- specific Ig E Antibody Test.

Hypothesis:-

Null Hypothesis- H0

There is no difference in the effect ofShigru Taila Nasya, Gaganesvara  Rasa with or without Haritakyadi Churna Virechana in Vataja Pratishyaya with special referenceTo Allergic Rhinitis.

Alternate Hypothesis-

There is difference in the effect ofShigru Taila Nasya, Gaganesvara  Rasa with or without Haritakyadi Churna Virechana  in  Vataja Pratishyaya with Special reference To Allergic Rhinitis.