| CTRI Number |
CTRI/2024/12/077581 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to compare the Effect of Dashmoola Avaleha and Shirish Avaleha in the Management of Vataj pratishaya
( Allergic rhinitis ) in children |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative Controlled
Clinical Study to evaluate the efficacy of Dashmoola Avaleha and Shirish Avaleha in the Management
of Vataja Pratishyaya (Allergic Rhinitis) in Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti Mehta |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra
HARYANA
136118Â India
Kurukshetra
HARYANA
136118
India |
| Phone |
7015029704 |
| Fax |
|
| Email |
shruti.bijjuwali17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kataria |
| Designation |
Associate professor |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9034001230 |
| Fax |
|
| Email |
dramitkataria@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Mehta |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra
HARYANA
136118Â India
Kurukshetra
HARYANA
136118
India |
| Phone |
7015029704 |
| Fax |
|
| Email |
shruti.bijjuwali17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for ayurved studies and research |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Institute for Ayurved Studies and Research Shri Krishna Ayush University Umri Road Sector 8 Kurukshetra 136118 |
| 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 |
| Dr Shruti Mehta |
Institute for Ayurved Studies and Research |
Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra
HARYANA
136118Â India
Kurukshetra
HARYANA |
07015029704
shruti.bijjuwali17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University IEC |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shirish Avaleha, Reference: Beshajaya ratanvali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 0.7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 17 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -this medications is taken from shastaryoga and no previous research work has been done | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashmoola avaleha, Reference: Bhesaj Ratanvali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 0.7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 17 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1 Signs and Symptoms of Vataja Pratishyaya (as per Ayurvedic classics) and Allergic Rhinitis (as per Allopathic science).
2 Parents of children willing to participate in the study
3 Age group: Between 6 to 14 years, irrespective of sex, religion, or socioeconomic status
4 SFAR score greater than 7
|
|
| ExclusionCriteria |
| Details |
1 Patients with a history of bronchial asthma, tuberculosis, pleural effusion, emphysema, lung abscess, bronchiectasis, pneumonia, or pleurisy
2 Patients below 6 years of age or above 14 years of age
3 Patients presenting with complications of allergic rhinitis such as nasal polyps, tumor of the nose, or deviated nasal septum (DNS)
4 Patients with a history of nasal surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes-
I. It will be accessed on the basis of statistical analysis applied on subjective parameters after
completion of trial. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Literary data related to Vataja Pratishyaya (Allergic rhinitis) will be compiled from different
texts of Ayurveda and modern part.
2.Effect of Pathya- Apathya will be assessed in the patients of Vataja Pratishyaya (Allergic rhinitis) |
7th 14th 21st 28th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/12/2024 |
| 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
|
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 (AR) is an inflammation of the nasal mucosa caused by an abnormal reactivity to an aeroallergen.Allergic rhinitis is a very common disorder that affects people of all ages, peaking in the teenage years. It is frequently ignored, under diagnosed, misdiagnosed, and mistreated, which not only is detrimental to health but also has societal costs. Allergic Rhinitis is an immunoglobulin E-mediated immunologic response of nasal mucosa to airborne allergens .Many treatment modalities are explained in Allopathic science like corticosteroids, anti-Allergic drugs, inhalers, antihistamines etc. but none of them are totally effective in curing the disease as well as preventing its recurrence, more over they have their own side effects like Rhinitis.So,this clinical trail has been designed to assess the efficacy of Dashmoola avaleha and shirish avaleha for oral administration in the management of Vataj pratishaya in children of age 6 year to 14 year is selected from O.P.D. of Kaumarbhritya Department of Institute for Ayurved Studies and Research. |