| CTRI Number |
CTRI/2019/03/018172 [Registered on: 19/03/2019] Trial Registered Prospectively |
| Last Modified On: |
14/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [PANCHKARAMA therapy of NASYAM ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management OF Vataj Pratishaya. |
|
Scientific Title of Study
|
A Clinico-Comparative Study To Evaluate The Efficasy Of Vidaryadi Ghrit Nasayam With And Without Tryooshan Churanam Orally In Vataj Pratishaya W.S.R TO Allergic Rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shailza Parashar |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no,1 Department of Shalakya Tantra Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7807754116 |
| Fax |
|
| Email |
sharmashail4466@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munna Kumar |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no,1 Department of shalakya Tantra Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9041249844 |
| Fax |
|
| Email |
kumar_mr27@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Munna Kumar |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no,1 Department of shalakya Tantra Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
UTTARANCHAL
249405
India |
| Phone |
9041249844 |
| Fax |
|
| Email |
kumar_mr27@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurveda College |
| Address |
Patanjali AYURVEDA Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shailza Parashar |
Patanjali Ayurveda Hospital |
OPD NO.1,Department of Shalakya Tantra Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL |
7807754116
sharmashail4466@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2017-18/17 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
effect of vidaryadi ghrit nasaym 8 dropes each nostril in vataj pratishya |
pateints will given nasaym of vidaryadi ghrit for 7 days. |
| Comparator Agent |
effect of vidaryadi ghrit nasyam in vataj pratishya and orally tryooshan churnam in vataj pratshaya |
patients will given nasyam with vidaryadi ghritam for 7 days and orally 3 gm tryooshan churnam with lukewarm water churanam for 15 days |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with signs and symptoms of Vataja 2.Pratishyaya (Allergic Rhinitis) as explained in classics.
3.Patients Yogya for Nasya Karma .
4.Patients yogya for orally medication.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 8 and above 60 yrs.
2.Patients with chronic infective respiratory diseases, other conditions like Nasal polyp, Tumors etc.
3.Patients with systemic illness like T.B. D.M. BA etc.
4.Patients Ayogya for Nasya Karma &orally medication(chooran).
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS:-
1.Anaddhapihita (Nasal Obstruction)
2.Tanusrava (Watery Discharge)
3.Kshavatu (Sneezing)
4.Kandu (Itching in the eyes, nose, pharynx)
4.Shira Shula (Head ache)
5.Post Nasal Discharge
OBJECTIVE PARAMETERS:-
1.Spatula Test
2.Anterior Rhinoscopic Findings (Colour of Mucosa)
3.Absolute eosinophil count
|
just before intervention of nasayam and orally medication in vataj Pratishyaya |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS:-
1.Anaddhapihita (Nasal Obstruction)
2.Tanusrava (Watery Discharge)
3.Kshavatu (Sneezing)
4.Kandu (Itching in the eyes, nose, pharynx)
4.Shira Shula (Head ache)
5.Post Nasal Discharge
 OBJECTIVE PARAMETERS:-
1.Spatula Test
2.Anterior Rhinoscopic Findings (Colour of Mucosa)
3.Absolute eosinophil count
|
just after intervention of nasayam and orally medication in vataj prtishyaya |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/03/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this trial,we are selecting the patients of Vataj Pratishyaya (allergic rhinitis) in which we will do the intervention in two groups (30 patients in each group ) . In one group , we will lintervene with ayurvedic therapy of nasayam with vidaryadi ghrit for 7 days whereas in other group we will intervene with ayurvedic therapy of nasaym for 7 days and orally medication for 15 days . Assessment should be done on the basis of investigations done during pre-treatment and post- treatment discussed earlier. |