CTRI Number |
CTRI/2023/08/055955 [Registered on: 01/08/2023] Trial Registered Prospectively |
Last Modified On: |
19/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Ayurvedic Treatment Of Allergic Rhinitis In children |
Scientific Title of Study
|
A Controlled Clinical Study To Evaluate The Effect Of Lavangadi Choorna Over Vyoshadi Choorna In Management Of Allergic Rhinitis (Vataja Pratishyaya ) In Children |
Trial Acronym |
Nill |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrShantlaxmi J N |
Designation |
PG Scholar |
Affiliation |
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital |
Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and hospital room no 13 kaumarbhritya OPD Gavimath campus Koppal Department of kaumarabhritya room No 13 Koppal Koppal KARNATAKA 583231 India |
Phone |
8904349207 |
Fax |
|
Email |
Shantlaxmin@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr G G Patil |
Designation |
HOD Professor Department of Kaumarabhritya |
Affiliation |
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital |
Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and hospital room no 13 kaumarbhritya OPD Gavimath campus Koppal Room no 13,Department of kaumarbhritya OPD Gavimath campus Koppal Koppal KARNATAKA 583231 India |
Phone |
9060896550 |
Fax |
|
Email |
gaviayu@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DrShantlaxmi J N |
Designation |
PG Scholar |
Affiliation |
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital |
Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and hospital room no 13 kaumarbhritya OPD Gavimath campus Koppal Department of kaumarabhritya Room no 13 Koppal Koppal KARNATAKA 583231 India |
Phone |
8904349207 |
Fax |
|
Email |
Shantlaxmin@gmail.com |
|
Source of Monetary or Material Support
|
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital Koppal |
|
Primary Sponsor
|
Name |
Dr Shantlaxmi J N |
Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and hospital room no 13 kaumarbhritya OPD Gavimath campus Koppal |
Type of Sponsor |
Other [Self sponsoring] |
|
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 Shantlaxmi J N |
Shree Jagadguru Gavisiddeshwara Ayurveda medical college Gavimata campus Koppal karnataka |
Department of Kaumarabhritya Room no 13 Gavimath Campus Koppal
karnataka Koppal KARNATAKA |
8904349207
shantlaxmin@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Istitutional Ethical Committee clearance Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital Koppal |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lavangadi Churna, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: vyoshadhi Churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
Children with signs and symptoms of allergic rhinitis aged between 2 to 16 year of with the recent onset within one week irrespective of gender religion and socio economic status fullfilling the diagnostic criteria will be included for the study |
|
ExclusionCriteria |
Details |
Children diagnosed with other type of dushtapratishyaya , raktaja pratishyaya and sannipataja pratishyaya
Chronic sinusitis , asthma , infectious diseases like TB and other systemic disorders which interfere in coarse of treatment |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Assessment of nasal congestion, rhinorrhea |
8 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assessment of Sneezing,Nasal itching,Nasal congestion,Rhinorrhea |
Assessed on 1st day, 30th day. 60th day |
|
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/ Phase 3 |
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="0" Months="3" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shantlaxmin@gmail.com].
- For how long will this data be available start date provided 01-11-2023 and end date provided 01-11-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
|
Allergic rhinitis1 is an acute IGE mediated , hypersensitivity reaction of nasal mucosa in response to antigenic substance (allergens) associated with episodic attacks of sneezing, watery rhinnorhea along with nasal congestion.In children it effects upto 20 to 40 %2 specially in prospective socities. Recent evidences suggest that the pervalance of disorder might be increasing day by day. Earlier allergic rhinitis was thought to be a disease localized to nasal cavity, however current understanding suggests that often the whole airway can get involved,due to physiological, functional and immunological relationships that exists between the upper respiratory tract and lower respiratory tracts3 .General features include nasal congestion , Itching ,sneezing,childrens often blow their nose or sniff or snort ,coughing ,may feel loss of smell etc. The line of treatment in allopathic system1,2,3 include use of antihistamines, steroids, nasal decongestents like sprays immunotherapy4 (limited) are available which are of majorly symptomatic treatment with many side effects like dryness of mouth ,irritation, drowziness, indigestion,anxiety, insomnia, heartburn5etc According to Ayurveda it can be co-related to vataja pratishyaya in context of pratishyaya. commonly described symptoms are nasavarodha,nasa kandu, nasa srava, khavathu6,7etc many treatment aspects with good number of shamanoushadhis have been explained,one among them is lavangadi choorna8, which act as dipana pachana, swasahara, kasahara and tridoshahara properties.this formulation is indicated in respiratory diseases like shwasa ,kasa, hikka tamakashwasa including pinasa, which is the avasta of pratishyaya itself. And it also imparts effect of rasayana9,which promotes the immunity also with releiving the symptoms.so an attempt has made to evaluate its effect in vataja pratishyaya with respect to allergic rhinitis,in comparision to vyoshadi churna10 which has already proved its efficacy in pratishyaya. |