跳至主要内容
临床试验/CTRI/2025/06/089664
CTRI/2025/06/089664尚未招募不适用

Clinical study to evaluate the combined effect of apamarga kshara taila prathimarsha nasya and oral administration of kumarabharana rasa in the management of hypertrophied adenoids in children.

Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月20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
20
试验地点
1
主要终点
reduction in nasal obstruction,mouth breathing, snoring ,reduction in size of adenoids

研究概览

简要总结

Respiratory diseases are the greatest cause of pediatric medical visits,  nasal obstruction is most common.1Adenoid hypertrophy(AH) is an obstructive condition due to increased size of adenoids2. Adenoids being a part of immune system and act as the first line of defence mechanism of aerodigestive tract3, they can get inflamed and enlarged by allergy of upper respiratory tract  recurrent attacks of  rhinitis , sinusitis or chronic tonsilitis4..

Adenoid hypertrophy occupies the most among all diseases of the upper respiratory tract in paediatric, accounting for about 34.5% according to NCBI a systematic review and Metaanalysis5. 0-75% adenoids enlargement is diagnosed at 3-10 years. The symptoms of adenoid hypertrophy tend to occur more among young children, because of the increased frequency of upper respiratory tract infections and the small volume of the nasopharynx.  Even though  this condition is generally self-resolving due to age-related adenoid atrophy,  AH can lead to a series of serious complications including sleep-disordered breathing and sleep apnea which in children can lead to growth failure, and neurocognitive abnormalities such as low intelligence quotient, learning and behavioral problems, poor attention span,ear infections, temporary hearing loss and Pulmonary hypertension6.

    The treatment options available for  adenoid hypertrophy are antibiotics, antihistamines  , nasal steroidsand surgical management called adenoidectomy may result in postoperative complications such as immediate and late bleeding (0.7%)7 ,vomiting  ,difficulties in swallowing and pain .recurrence of adenoid tissue is 20% The  risk of adenoid re-growth is slightly more common in patients who undergo adenoidectomy at a young age8.The complications arising from the medical and surgical management makes us to find out the alternative line of management with no added adverse effect .

In Ayurveda, adenoid enlargement can be well correlated with Kanthashaluka9owing to the marked similarities of the clinical presentations of hypertrophied adenoids like margarodha,kolavath granti10.As it is  an urdhwajatrugatavikara and nasya is widely adopted and effective treatment modalityfor the management11, in the present study pratimarshanasya is taken as choice of intervention . As the disease is kaphapradhana the drug of choice should have,katu rasa,ushnateekshna guna12hence apamargataila is selected for pratimarshanasya and kumarabharana tablet internally.

As apamarga is having katutikta rasa ushnaveerya,shodana and ropana property, it is  taken as drug of choice and Kumarabharana Rasa is Anubhuta Yoga (formulation) which is very effective in management of chronic respiratory diseases especially in children as it is observed during the clinical practice13 .Hence in the present study an attempt is made to evaluate the combined effect of prathimarshanasya with apamargaksharatailaand kumarabharana tablet internally in hypertrophied adenoids

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • .Subject of age group 3-8 years of either sex who fulfill the diagnostic criteria 2.The subject whose parents are willing to participate their child in the study and ready to sign the consent form.

排除标准

  • Subject associated with fever.
  • 2.Subject associated with nasal polyp and nasal bleeding.
  • 3.Subject with any other systemic illness.

结局指标

主要结局

reduction in nasal obstruction,mouth breathing, snoring ,reduction in size of adenoids

时间窗: 0th day (BT) 15th day (DT) 30th day (AT) 15th day (FU)

次要结局

  • impact on health status(reduction in recurrent infection)

研究者

发起方
Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Chandana Lakshmi

Sri dharmastala manjunatheshwara college of ayurveda and hospital thanneruhalla bm road hassan.

研究点 (1)

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