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临床试验/CTRI/2025/09/094865
CTRI/2025/09/094865尚未招募不适用

A Randomized Controlled Clinical Study on the Effectiveness of Ghritaguggulasikhta Dhoomnasya in the Management of Kshawathu with special reference to Allergic Rhinitis

Sukeshini Dadaji Moon1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年9月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
156
试验地点
1
主要终点
Change in presence of eosinophils in nasal smear from baseline Day 0 to Day 7

研究概览

简要总结

Title

A Randomised Controlled Clinical Study On Effectiveness Of GhritaguggulsikthaVarti Dhum Nasya In The Management of Kshwathu With Special Reference To Allergic Rhinitis

02

Brief Introduction

Allergic Rhinitis AR is caused by IgE immunoglobulin E mediated reactions to inhaled allergens and one of the most common chronic condition globally Allergic rhinitis generally found with allergic conjunctivitis  and allergen Caused Asthma Various allergens like pollens tree grass weeds including ragweed moulds and indoor allergens like house dust mites and animal allergens are responsible for developing the allergic rhinitis Allergic Rhinitis likes to be the consequence of environmental exposure acting on a predisposing genetic factors AR is world health problem that causes major burden and disability of work AR responds to missed or unproductive time at work school sleeping problems and sufferers decrease the involvement in out door activities Allergic rhinitis affects the quality of life social life school and work and patient feels embracing because of paroxysmal sneezing1 Allergic Rhinitis is a highly prevalent Chronic disease which presents enormous global health burden It is estimated that at least 500 millions population have allergic rhinitis and common cause for attending the primary care practitioner2 The prevalence of Allergic Rhinitis has increased world wide since the 1960s in parallel to the increase in the prevalence of factors tendency to produce IgE antibodies owing to genetic or environmental factors3 The problem of Allergic Rhinitis is enormous constituting about 55 of all allergies about 2030 of Indian population suffers from Allergic Rhinitis Studies have shown  that prevalence of Allergic Rhinitis has been increasing in India over past few years According to  international study of Allergies in childhood ISSAC phase 1 1998 in India nasal symptoms alone were present in 125 children in 67 years age group and 196 in 1314 Years age group However in ISSAC phase 3 2009 study prevalence of nasal symptoms increased to 129 and 236 in 67 and 1314 years age groups respectively4 Allergic Rhinitis is characterized by sneezing nasal discharge rhinorrhoea nasal conjestion and nasal itching and blocking of nose5 According to Acharya Sushruta sneezing is present in other nasal disease also but it is separately mentioned as a separate disease itself term as Kshwathu Acharya  Sushruta describes kzkkkfJrs eeZfk laiznqVs Lkfuyks ukfldk fujsfr AA11AA dQkuqkrks cgqk lkCnLra jksxekgq koFkqa fofkKk lqm 2211 It means when vitiated and aggrevated vata dosha passes to moordha through nasa pathway it irritates the nasa Ashrit Marma Shringataka Marma and creates Kshwathu Sneezing56                    According to Sushrut Acharya also it has two types 1 Doshaj Kshwathu and 2 Aagantuj Kshwathu rhkksiksxknfrftkzrks ok Hkkoku dVwudZfujhkkkkAA lwkfnfHkZokZ rkkfLFkeeZqkfVrsU koFkqfuZjsfrA lqmv 2212 5 6 Because of Inhalation of tikshna dravya like Mustard Marich powder and other drug like Suntha Pippali Tobacco inhalation in higher doses observation of sunrays for more time entry of cotton thread into nasal cavity shringtaka marma irritates and causing sneezing called as Aagantuj kshwathu Ayurvedic treatment is the system of medicine which proposes the need of undertaking the clarification of biological system from gross channels upto molecular levels aiming to purification of entire body of vitiated factors which promotes prevention of diseases and promotion of health Solutions of this disease should be bidirectional as indicated by its vata and kapha dosha predominance Medication administered through nose to get desired therapeutic effects known as nasya therapy which acts on nasal mucosa Nasya can be advised in a person for treatment as well as prevention of diseases According to Charak Acharya Nasya karma is devided into five types 1Navana Nasya 2Avapidana Nasya  3 Dhmapana Nasya  4 Dhumanasya 5 Pratimarsha Nasya According to Acharya sushruta there are mainly 2 types of Nasya which are shirovirechana nasya and sneha nasya Apart from these other classification according to Acharya sushruta also five types Nasya shirovirechana nasya pratimarsh nasya avapidan nasya and pradhaman nasya 7 Navan Nasya the procedure of dropping the ghrita medicated oil into the nostril called as Navan nasya Eg Anutail Shadbindu tail nasya are the navan nasya Avapidan Nasya medicinal herbs are crushed into a paste and the squeezed to extract the juice which is dropped into the nostrils Dhmapana Nasya Pradhmana nasya  Medicinal herbs are used in the fine powder and blown into the nostrils Pratimarsha Nasya Medicated oil dropped into the nostrils in a small and specific dose as 2 drops always DhumNasya smoke getting from burning the herbal medicinal plants is inhaled through the nostrils is called as Dhum Nasya It has 3 subtypes like prayogika dhum Vairechnik dhum and snahika dhum Drug are powdered and kept into a hollow stick and attached to the smoking pipe and its one end is lighted The smoke of it inhaled by nose 333 times This is the dose for prayogika nasya Length of prayogika dhumnetra is 36 angula and snaihika dhum netra is 32 angula and vairechanika dhumnetra is 26 angula So dhumnasya method is used for the treating the allergic rhinitis in my study Dhumpana and Dhumnasya are different  Dhumpana is generally given after nasya karmaAfter nasya karma vitiated kapha accumulated into the nose and head developing various diseases so dhumpana is given in that case Dhumpana is mentioned by Acharya charak Dhumpana is the procedure in which medicated  smoke is taken and emit from mouth and according to chakrapani in Dhumnasya medicinal herbs dhum is taken by Nasa and in dhumpana smoke is taken by the mouth7

STUDY RATIONALE The present study describes the evaluation and treatment of AR and highlights the role of ayurvedic doctors in improving care and treating allergic conditions alsoAR is knowns to peak in the second to forth decade of life which is more product full age Intranasal administration has assumed in the last years an increasingly value as an alternative strategy for the local absorption of drug to vascularized nasal mucosaSo dhumnasya will help  to cure and prevent the AR It also include in daily routine procedure as dincharya Keeping this in view the present study will be carry out

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
7.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Study subjects suffering from allergic rhinitis Study subjects of age group 7 to 80 years Study subjects ready to give consent.

排除标准

  • The following are general acceptance on the exclusion criteria for treatment of allergic rhinitis Asthma with the exception of mild intermittent asthma Chronic or intermittent use of inhaled oral intramuscular intravenous and or potent topical corticosteroids Use of leukotriene modifiers Use of long acting antihistamines Documented evidence of acute or significant chronic sinusitis as determined by the individual investigator Chronic use of concomitant medications eg antidepressants that would affect the assessment of the effectiveness of new treatment A history of hypersensitivity to the product or its contents Presence of rhinitis secondary to other causes Planned travel outside the trial area for a substantial portion of the trial period Systemic conditions such as DM HT HIV Any severe life threatening confounding disorder Malignancy polyps in nasal cavity.

结局指标

主要结局

Change in presence of eosinophils in nasal smear from baseline Day 0 to Day 7

时间窗: Baseline and day 7th

次要结局

未报告次要终点

研究者

发起方
Sukeshini Dadaji Moon
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Sukeshini Dadaji Moon

Government Ayurved college Nagpur

研究点 (1)

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