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临床试验/CTRI/2021/03/031637
CTRI/2021/03/031637已完成Phase 3 4

Endoscopic evaluation of surface distribution of different morphological forms of Nasya in healthy volunteers

Chaudhary Brahm Prakash Ayurved Charak Sansthan1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年1月3日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
To evaluate distribution pattern difference between different morphological forms of Nasya i.e. How lipid/ oil bas Nasya are different from powder form and Aqueous form

研究概览

简要总结

This study was done in order to analyse the areasin nasal cavity tends to be affected during nasal administration of variousmorphological form of drugs and also to provide scientific approach to NasyaKarma, by means of endoscopic evaluation of nasal cavity done after Nasya.

For this purpose, 90 healthy volunteers wereregistered and divided into three groups i.e., 30 volunteers in each group,which then scrutinized by ENT department in order to check any rhino logicalpathology (if present). After examination the three groups were, Group A (inwhich nasal administration of lipid base nasal drops by using MadhuyashtyadiTail was done), Group B (in which aqueous form was administered intranasally byusing Madhuyashti Kwath) And Group C (in which nasal administration of powderwas done by using Madhuyashti Churna).

The excerpt of different morphological form ofNasya drug distribution pattern with special reference to different walls ofthe nasal cavity is reproduced here after as conclusion.

In the respiratory region (i.e., lateral wall,medial wall and floor)

The lateral wall was majorly occupied by lipid basenasal drops i.e., Madhuyastyadi Tail and powder form i.e., Madhuyashti Churna(both have same percentage i.e., 96.7%), and moderately by aqueous form i.e.,Madhuyashti Kwath (i.e., 70%).

The medial wall was considerably occupied by powderform (Madhuyashti Churna) (100%), moderately by aqueous form (MadhuyashtiKwath) (90.0%), and scarcely by lipid form (Madhuyashtyadi Tail) (63.3%).

The floor of nasal cavity was majorly occupied byMadhuyashti Churna (90.0%) and Madhuyashti Kwath (93.3%) and moderately byMadhuyastyadi Tail (76.7%).

According of above statements, the overallrespiratory region (i.e., lateral wall, medial wall and floor), was majorlyoccupied by Madhuyashti Churna, which means Churna or powder formulationsshould use intranasally in all that conditions in which systemic approach isneeded (as respiratory region is the highly vascularised area of nasal cavity).It can also use in conditions where immediate irritant effect is needed asmentioned by Acharya Charak in Sanyaas Chikitsa, Visha Chikitsa (24 treatmentmodalities of Acute poisoning mainly snake/insect bite).

As Madhuyashti Kwath majorly occupies medial wall,so aqueous base nasal drugs should be use in conditions related to medial walllike anterior epistaxis, as Acharya Charak has mentioned use of variousextracts in the treatment of Nasa-gata Raktapitta.

In the roof of nasal cavity i.e., Olfactory region

The Madhuyashtyadi Tail occupied olfactory areaconsiderably than the other form i.e., Kwath and Churna form, so oil basednasal preparations are used to target Centre Nervous System.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •1.Individual 16 years to 60 years 2.Healthy volunteers from outside CBPACS.

排除标准

  • •1.People not giving their consent 2.Having significant DNS which hampers endoscopic examination and photography 3.Having Nasal polyps, Sinusitis and other nasal pathological conditions 4.Having previous history of nasal surgery 5.Peoples hypertensive with local anaesthetic agent i.e Xylocaine in this study.

结局指标

主要结局

To evaluate distribution pattern difference between different morphological forms of Nasya i.e. How lipid/ oil bas Nasya are different from powder form and Aqueous form

时间窗: 1 day

次要结局

  • To evaluate distribution pattern of three morphological forms of Nasya i.e. lipid,aqueous and powder form(1 day)

研究者

发起方
Chaudhary Brahm Prakash Ayurved Charak Sansthan
申办方类型
Government medical college

研究点 (1)

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