| 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
|
|
|
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
|
|
|
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. |