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CTRI Number  CTRI/2021/03/031637 [Registered on: 01/03/2021] Trial Registered Prospectively
Last Modified On: 23/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Endoscopic evaluation of nasal medications in healthy volunteers. 
Scientific Title of Study   Endoscopic evaluation of surface distribution of different morphological forms of Nasya in healthy volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashu Sharma 
Designation  PG Schlor 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi 
Address  Room No.208, Hospital block,CBPACS,Khera Dabar, Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  7982509860  
Fax    
Email  ASHUSHARMAPUROHIT63@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Arun Gupta 
Designation  Head Of Department Of Panchkarma 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi 
Address  Room No.142,CBPACS,Khera Dabar, Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  9999155377  
Fax    
Email  ARUN24@HOTMAIL.COM  
 
Details of Contact Person
Public Query
 
Name  Ashu Sharma 
Designation  PG Schlor 
Affiliation  CBPACS,Khera Dabar, Najafgarh New Delhi 
Address  Room No.208, Hospital Block,CBPACS,Khera Dabar, Najafgarh New Delhi

South West
DELHI
110073
India 
Phone  9868982879  
Fax    
Email  Ashusharmapurohit63@gmail.com  
 
Source of Monetary or Material Support  
chaudhary brahm prakash ayurved charak sansthan,khera dabar,najafgarh 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  cbpacs,Khera Dabar,Najafgarhh,New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ashu Sharma  Ch Brahm Prakash Ayurved Charak Sansthan  Minor OT, first floor,Hospital Block,Cbpacs Khera Dabar Najafgarh
South West
DELHI 
9868982879

ashusharmapurohit63@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CBPACS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nasal administration of madhustyadi oil,madhuyasti churna,madhuyasti kwath  Nasal administration of madhuyastadi oil 10 drop in each nostril, madhuyasti churna approx 250mg in each nostril, madhuyastyadi kwath 8 drop in each nostril. to see their surface distribution by endoscopy. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Individual 16 years to 60 years
2.Healthy volunteers from outside CBPACS 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  1 day 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate distribution pattern of three morphological forms of Nasya i.e. lipid,aqueous and powder form  1 day 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/03/2021 
Date of Study Completion (India) 05/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/03/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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

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

The excerpt of different morphological form of Nasya drug distribution pattern with special reference to different walls of the 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 base nasal 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 powder form (Madhuyashti Churna) (100%), moderately by aqueous form (Madhuyashti Kwath) (90.0%), and scarcely by lipid form (Madhuyashtyadi Tail) (63.3%).

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

According of above statements, the overall respiratory region (i.e., lateral wall, medial wall and floor), was majorly occupied by Madhuyashti Churna, which means Churna or powder formulations should use intranasally in all that conditions in which systemic approach is needed (as respiratory region is the highly vascularised area of nasal cavity). It can also use in conditions where immediate irritant effect is needed as mentioned by Acharya Charak in Sanyaas Chikitsa, Visha Chikitsa (24 treatment modalities 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 wall like anterior epistaxis, as Acharya Charak has mentioned use of various extracts in the treatment of Nasa-gata Raktapitta.

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

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


 
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