| CTRI Number |
CTRI/2022/11/047469 [Registered on: 21/11/2022] Trial Registered Prospectively |
| Last Modified On: |
01/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on the efficacy of Bal-Rasayana®syrup in children suffering from Allergic Rhinitis |
|
Scientific Title of Study
|
An open label, non comparative and prospective clinical trial on the efficacy of Bal-Rasayana®syrup in children suffering from 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 Ajay Ravindra Chavan |
| Designation |
PhD Scholar |
| Affiliation |
Bharati Vidyapeeth University College of Ayurved |
| Address |
Department of Kaumarbhritya, Bharati Vidyapeeth University College of Ayurved, Pune-Satara Road, Pune -43
Pune
MAHARASHTRA
411043
India |
| Phone |
9595913663 |
| Fax |
|
| Email |
dr.ajayrchavan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Gujarathi |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth University College of Ayurved |
| Address |
Department of Kaumarbhritya, Bharati Vidyapeeth University College of Ayurved, Pune-Satara Road, Pune -43
Pune
MAHARASHTRA
411043
India |
| Phone |
9420322740 |
| Fax |
|
| Email |
rahul.gujarathi@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Ravindra Chavan |
| Designation |
PhD Scholar |
| Affiliation |
Bharati Vidyapeeth University College of Ayurved |
| Address |
Department of Kaumarbhritya, Bharati Vidyapeeth University College of Ayurved, Pune-Satara Road, Pune -43
Pune
MAHARASHTRA
411043
India |
| Phone |
9595913663 |
| Fax |
|
| Email |
dr.ajayrchavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth University College of Ayurved and Hospital, Pune-Satara Road, Pune - 43 |
|
|
Primary Sponsor
|
| Name |
Gurukrupas Amruta Ayurveda LLP |
| Address |
Bela Mater, Ground Floor, Opposite IndusInd Bank, Near Hotel Taj Vivanta, St. Inez, Panaji, North Goa-403001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Ajay Chavan |
Bharati Vidyapeeth Medical Foundations Ayurved Hospital |
Balroga OPD, Room No. 9
Pune
MAHARASHTRA |
9595913663
dr.ajayrchavan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVCOAEC |
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: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: BalRasayana, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 23(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Dose is as per the age of the child |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as suffering from Vataja Pratishyaya on Ayurvedic parameters (allergic rhinitis)
2. Age group of 3 to 16 years
3. Cardinal features of allergic rhinitis
4. History of at least 3 episodes in last six months
|
|
| ExclusionCriteria |
| Details |
1. Individuals below 3 years and above 16 years
2. Severe and Complicated respiratory allergic disorders like Bronchitis, Pneumonia, Tuberculosis, Emphysema, Lung abscess, bronchieactasis
3. Patients who are diagnosed as asthma
4. Nasal polyposis
5. Congenital anomalies related to respiratory system
6. Patients on inhaled or systemic steroids
7. Patients who are suspected of any of the diseases mentioned in exclusion criteria on the basis of history and examination will be excluded
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in episodes of allergic rhinitis
2. Reduction in severity of allergic rhinitis |
30, 60 and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in Laboratory parameters
2. Improvement in morbidity specifically time to recovery, number of acute lower respiratory tract infections (ALRI) and hospitalizations during the treatment phase
|
30, 60 and 90 days |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An open label, non comparative and prospective trial will be conducted to evaluate the efficacy of Bal-Rasayana syrup in the management of allergic rhinitis in children. Children with predominant symptoms of allergic rhinits between the age group of 3 to 16 years will be selected clinically from OPD. Drug will be given as per dose explained in classics in morning and evening before snacks. Duration of trial will be of 90 days. treatment start - Day 0. Follow up on 30th, 60th and 90th day. Patient will be reviewed on 120th day. Primary end point - 90th day and secondary end point - 120th day |