| CTRI Number |
CTRI/2025/03/083528 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Respiratory allergy in childhood |
|
Scientific Title of Study
|
Establishment Of Childhood Respiratory Allergy Care Centre W.S.R. To Vasa And Kantakari Extract Arosol Nebulization/ Inhalation |
| Trial Acronym |
Childhood Respiratory Allergy Care Centre-Vasa & Kantakari |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitya Yadav |
| Designation |
PG STUDENT |
| Affiliation |
Banaras Hindu University |
| Address |
Department Of Kaumarbhritya Balroga Faculty Of Ayurveda Institute Of Medical Sciences Banaras Hindu University Varanasi
Uttar Pradesh
221005
INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9140281735 |
| Fax |
|
| Email |
ng6739885@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prem Shanker Upadhyay |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department Of Kaumarbhritya Balroga Faculty Of Ayurveda Institute Of Medical Sciences Banaras Hindu University Varanasi
Uttar Pradesh
221005
INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7355422083 |
| Fax |
|
| Email |
upadhyayps1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prem Shanker Upadhyay |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department Of Kaumarbhritya Balroga Faculty Of Ayurveda Institute Of Medical Sciences Banaras Hindu University Varanasi
Uttar Pradesh
221005
INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7355422083 |
| Fax |
|
| Email |
upadhyayps1974@gmail.com |
|
|
Source of Monetary or Material Support
|
| kaumarbhritya balroga OPD No 25Indian Medicine Wing Sir Sunderlal Hospital IMS BHU |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Sir Sunderlal Hospital Institute Of Medical Sciences Banaras Hindu University Varanasi, 221005, Uttar Pradesh, India |
| 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 |
| Dr Prem Shanker Upadhyay |
Institute Of Medical Sciences, Banaras Hindu University |
Department Of Kaumarbhritya Balroga Faculty Of Ayurveda Institute Of Medical Sciences Banaras Hindu University Varanasi
Uttar Pradesh
221005
INDIA
Varanasi
UTTAR PRADESH |
07355422083
upadhyayps1974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute Of Medical Science, Banaras Hindu University, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vasa & Kantakari , Reference: Charaka Samhita , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 0.075(mg), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Age - between 5 yr to 14 years. 2. Sex – both male and female. 3. Mild to moderate case of Respiratory Distress. 4. Case of productive and unproductive cough. 5. Case of acute or chronic cough. |
|
| ExclusionCriteria |
| Details |
Severe case of shwas rog.
Severe pneumonia.
Status asthamaticus.
Cardiac asthma.
Cough which is associated with blood. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
CBC
ESR
IgE
LFT
RFT |
Before intervention
Then after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in criteria in the scale for
Recurrent fever
Respiratory distress
Case of productive & unproductive cough
Respiratory allergy |
FOLLOW UP ON
3days
7days
14days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/04/2025 |
| 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="2"
Days="1" |
|
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 occur when your body misidentifies a harmless substance (called an allergen) as dangerous. Your immune system responds to the false alarm and begins to make antibodies against the allergen. The next time you come in contact with the substance, the antibodies cue the release of allergic chemicals into the bloodstream, resulting in allergic symptoms. |