CTRI Number |
CTRI/2021/04/032933 [Registered on: 19/04/2021] Trial Registered Prospectively |
Last Modified On: |
11/04/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ayurvedic Management in Rhinitis |
Scientific Title of Study
|
Comparative Clinical Study To Evalauate The Effect Of Trikatu Avapidana Nasya And Trikatu Taila Nasya On Nasal Mucosa In Vataja Pratishyaya (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 |
Dr PADMAN |
Designation |
PG Scholar |
Affiliation |
Rajiv gandhi university of health sciences bengaluru |
Address |
Room No 01
Department Of Shalakya Tantra
Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College,Postgraduate Studies And Research Center, Koppal.
Koppal KARNATAKA 583231 India |
Phone |
9845675317 |
Fax |
|
Email |
padmanadang@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr VEERAYYA R HIREMATH |
Designation |
professor and HOD |
Affiliation |
Sri Jagadguru gavisiddeshwara ayurvedic medical college |
Address |
Room no 01
Department of Shalakya Tantra
Sri Jagadguru gavisiddeshwara ayurvedic medical college,postgraduate studies and research center, koppal.
Koppal KARNATAKA 583231 India |
Phone |
9448544376 |
Fax |
|
Email |
drveerurh@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr VEERAYYA R HIREMATH |
Designation |
Professor and HOD |
Affiliation |
Rajiv gandhi university of health sciences bengaluru |
Address |
Room No 01
Department Of Shalakya Tantra
Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College,Postgraduate Studies And Research Center, Koppal
Koppal KARNATAKA 583231 India |
Phone |
9448544376 |
Fax |
|
Email |
drveerurh@yahoo.co.in |
|
Source of Monetary or Material Support
|
Department Of Shalakya Tantra |
|
Primary Sponsor
|
Name |
Department of Shalakya Tantra |
Address |
Room No 01
Department Of Shalakya Tantra
Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College,Postgraduate Studies And Research Center, Koppal.
|
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 |
DrPadmaN |
Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College |
Room No 01
Department Of Shalakya Tantra
Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College,Postgraduate Studies And Research Center, Koppal.
Koppal KARNATAKA |
9845675317
padmanadang@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SJG INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Trikatu Avapidana Nasya
|
Trikatu Avapidana Nasya for 7 days . |
Comparator Agent |
Trikatu Taila Nasya |
Trikatu Taila Nasya for 7 days. |
|
Inclusion Criteria
|
Age From |
7.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients having signs and symptoms of allergic rhinitis(Vataja Pratishyaya)
2.Irrespective of their gender, socio-economic status, educational status and religion.
3.Age group between 7 to 60 years.
|
|
ExclusionCriteria |
Details |
1.Patients unfit for Nasya.
2.Patients suffering from nasal polyposis, nasal carcinoma, epistaxis.
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
REDUCTION in
1.Watery nasal discharge
2.Nasal obstruction
3.Sneezing
|
7 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Complete absence in
1.Watery nasal discharge
2.Nasal obstruction
3.Sneezing
|
37 days |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
26/04/2021 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Allergic
Rhinitis is an IgE mediated immunologic response of nasal mucosa to air borne
allergens and is characterized by watery nasal discharge, nasal obstruction,
sneezing and itching of nose, eyes, palate and pharynx. It is two types they
are seasonal and perennial.It is better considered as a unified
allergic airway, or even a systematic disease- with inflammatory changes in
circulation and bone marrow. More than 10million people are
affected by allergic rhinitis in India irrespective of age group. It
has negative impact on the quality of life. Allergic Rhinitis may be compared with Vataja
Pratishyaya, characterized by watery nasal discharge, nasal blockage,
difficulty in breathing, dryness of throat, palate, lips along with pricking
type of pain in temporal region and change in voice and sneezing
.
Allopathic Treatment involves oral administration
of anti-histamine, alpha-adrenergic and corticosteroid drugs, which have side
effects like drowsiness, rhinitis medicamentosa and mucosal atrophy respectively,
other treatment modalities includes avoidance of allergen and immunotherapy. Immunotherapy shows no clinical improvement after prolonged usage.
In Vataja
Pratishyaya treatment
protocol of Ardita, Vataja Kasa, and Pinasa are advocated.
It includes Sneha Dhuma, Swedana, Upanaha, Anutaila Nasya , Avapidana
Nasya, Pradhamana Nasya, Asthapana Basti.Intake
of Ghrita , Maricha with Guda, and Vyoshadi Vati.
Since, both Taila and Avapidana Nasya
are advocated in management of Vataja Pratishyaya, this study is aimed
to compare the effect of Trikatu Taila and Trikatu Avapidana Nasya
on nasal mucosa in the management of Vataja Pratishyaya. |