Study of the effect of Shigru Taila Nasya,Gaganesvara Rasa and Haritakyadi Churna Virechana in Allergic Rhinitis.

Completed

• Conditions: Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH,

• Registration Number: CTRI/2022/07/043987
• Lead Sponsor: National institute Of Ayurveda Deemed To Be University Jaipur

Brief Summary

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**na*help in diverting the *Doshas* from *Shak**h**as* to*Koshta* 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** **R****andomized 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** 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 *Vataj*a *Pratishyaya* with special reference to Allergic Rhinitis.

·         To evaluate the efficacy of *Shigru Taila Nasya* and *Gaganesvara* *Rasa* orally without *Haritakyadi* *Churna* *Virechana* in *Vataj*a *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 M*arsha 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 of*Shigru 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 of*Shigru Taila* *Nasya*, *Gaganesvara*  *Rasa* with or without *Haritakyadi Churna Virechana*  in  *Vataja Pratishyaya* with Special reference To Allergic Rhinitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-12
• Last Update Posted: 2023-01-11
• Study Completion: 2023-06-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• (1) Patients willing to participate in the study (2) Patients between the age group of 18– 60 yrs.
• (3) Patients presenting with signs and symptoms of Vataja Pratishyaya mentioned in Ayurvedic Classics and Allergic Rhinitis according to Allopathic science.

Exclusion Criteria

• 1.Patients having history of systemic disease as Diabetes Mellitus, Hypertension, Hypothyroidism.
• 2.Patients suffering from gross deviation of nasal septum, nasal tumours, adenoid hyperplasia, nasal polyps etc.
• 3.Pregnant women.
• 4.Patients not fit for Nasya therapy and Virechana.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in visual analogues scale.	30 days

Secondary Outcome Measures

Name	Time	Method
Change in nasal congestion and turbinate hypertrophy.	30 days

Trial Locations

Locations (1)

National Institute Of Ayurveda Deemed To Be University Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute Of Ayurveda Deemed To Be University Jaipur

🇮🇳Jaipur, RAJASTHAN, India

DrManish Kumar Varshney

Principal investigator

9784596886

varshney43manish@gmail.com