| CTRI Number |
CTRI/2023/06/054256 [Registered on: 21/06/2023] Trial Registered Prospectively |
| Last Modified On: |
24/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of chaturajata taila inhaler in allergic rhinitis |
|
Scientific Title of Study
|
To develope and evaluate the efficacy of chaturajata taila inhaler in vataj pratishay with special reference to allergic rhinitis-a randomized controlled prospective clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjiri Keskar |
| Designation |
Hod and Professor in Department of Shalakya Tantra |
| Affiliation |
Parul institute of ayurved |
| Address |
OPD 112
Parul Ayurved hospital
Shalakya tantra department
Parul institute of ayurved
Parul university
At post limda
Tal waghodia
Dist Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
manjirikeskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Jain |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul institute of ayurved |
| Address |
OPD 112
Parul Ayurved hospital
Shalakya tantra department
Parul institute of ayurved
Parul university
At post limda
Tal waghodia
Dist Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8982530124 |
| Fax |
|
| Email |
pjprashantrock2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Jain |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul institute of ayurved |
| Address |
OPD 112
Parul Ayurved hospital
Shalakya tantra department
Parul institute of ayurved
Parul university
At post limda
Tal waghodia
Dist Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8982530124 |
| Fax |
|
| Email |
pjprashantrock2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital
Parul University
PO limda
Tah waghodia
Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
Dean Parul institute of ayurved |
| Address |
Parul Ayurved Hospital Parul university PO limda Tah waghodia Vadodara 391760 |
| Type of Sponsor |
Private 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 |
| Dr Prashant Jain |
Parul institute of ayurved |
OPD 112
Parul Ayurved Hospital
Shalakya tantra department
Parul Institute of Ayurved
Parul University
At post limda
Tal waghodia
Dist Vadodara
Vadodara
GUJARAT |
8982530124
pjprashantrock2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: VATAJ PRATISHAY, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Nasal inhalation | (Procedure Reference: NA, Procedure details: Take deep inhalations from the Inhaler 5 times/day or as and when required through one of
the nostrils (3 times inhale) while keeping the other nostril gently closed. Same procedure
will be followed through the other nostril)
| | 2 | Comparator Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Susruta samhita chi.40/51, Procedure details: Application of CHATURJATA NASYA 2 drop instil in each nostril
Pinch the nose once and after releasing, suck the Tail up spit the Tail when it reaches
the throat
Tail is insert into one nostril while other is closed (Pinched))
(1) Medicine Name: Chaturjata Taila, Reference: Yogratnakar Nasarogadhikar 65/67, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient having symptoms of Vataj Pratishyay
Age between 18-40yrs
Those who give consent as per requirement |
|
| ExclusionCriteria |
| Details |
Patients with known case of hypertension, Diabetic mellitus, heart disease and bronchial asthma
Patients presenting with complications of pratishyay like nasal polyps, tumour of nose, DNS, old fracture of nose.
If patients is suspected of COVID – 19 infection after scanning with respect to clinical signs & symptoms and history of patients, than he/she
will be referred through proper channel for further treatment. She/he will not be included in trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The patient will improve in nasasrav kshavathu shirashoola |
Day 8
Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The patient will improve in nasaanaha |
Day 8
Day 15 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Allergic rhinitis is very common diseases among all the age groups Allergic rhinitis is not a serious illness, it is clinically relevant because it will cause many complications and affects qualitry of life, and productivity at school and work place Nose is one of the most delicate and exposed organ of the body and it is the most common site for all allergic reactions In modern medicine nasal sprays are the most effective treatment, but it comes with some limitations This study aims at introducing a cost effective, easy to handle, easy to use nasal inhaler
|