| CTRI Number |
CTRI/2024/05/067252 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Immunity booster on respiratory tract infections |
|
Scientific Title of Study
|
An open label non comparative prospective clinical trial on the efficacy
of BalRasayana syrup as an immunomodulator and its role in recurrent
respiratory tract infections in children |
| Trial Acronym |
IMB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubhangi Thakur |
| Designation |
Assistant professor |
| Affiliation |
R A Podar medical college AYU Worli Mumbai |
| Address |
PD NO 17 KAUMARBHRITYA OPD M A PODAR HOSPITALDR ANE BESENT ROAD WORLI MUMBAI 400018
OPD NO 17 KAUMARBHRITYA OPD M A PODAR HOSPITALDR ANE BESENT ROAD WORLI MUMBAI 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9404622180 |
| Fax |
|
| Email |
shubhangikthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Thakur |
| Designation |
Assistant professor |
| Affiliation |
R A PODAR MEDICAL COLLEGE AYU WORLI MUMBAI |
| Address |
OPD NO 17 KAUMARBHRITYA OPD M A PODAR HOSPITALDR ANE BESENT ROAD WORLI MUMBAI 400018
OPD NO 17 KAUMARBHRITYA OPD M A PODAR HOSPITALDR ANE BESENT ROAD WORLI MUMBAI 400018
MAHARASHTRA
400018
India |
| Phone |
9404622180 |
| Fax |
|
| Email |
shubhangikthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Thakur |
| Designation |
Assistant professor |
| Affiliation |
R A PODAR MEDICAL COLLEGE AYU WORLI MUMBAI |
| Address |
PD NO 17 KAUMARBHRITYA OPD M A PODAR HOSPITALDR ANE BESENT ROAD WORLI MUMBAI 400018
OPD NO 17 KAUMARBHRITYA OPD M A PODAR HOSPITALDR ANE BESENT ROAD WORLI MUMBAI 400018
MAHARASHTRA
400018
India |
| Phone |
9404622180 |
| Fax |
|
| Email |
shubhangikthakur@gmail.com |
|
|
Source of Monetary or Material Support
|
| R A Podar medical college AYU and M A Podar hospital Worli Mumbai 400018 |
|
|
Primary Sponsor
|
| Name |
GURUKRUPA AMRUTA AYURVEDA LLP |
| Address |
GURUKRUPA AYURVEDICS BELA MATER FLAT NO 2 GROUND FLOOR OPPOSITE INDUSIND BANK NEAR HOTEL TAJ VIVANTA ST LENZ PANJI 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 Shubhangi Thakur |
R A Podar medical college and M A podar hospital Worli Mumbai |
OPD NO 17 KAUMARBHRITYA OPD M A PODAR HOSPITAL WORLI MUMBAI 400018
Mumbai
MAHARASHTRA |
9404622180
shubhangikthakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee R A Podar Medical college Worli Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J209||Acute bronchitis, unspecified. Ayurveda Condition: KASAH, |
|
|
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: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -leukewarm water), Additional Information: -doses decided as per age and weight afer giving 2 month medication 1 month follow up period to observe patient respiratory tract symptoms |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as suffering from Vataja Pratishyaya on Ayurvedic parameters
Age group of 3 to 16 years.
Cardinal features of recurrent respiratory tract infections
History of at least 3 episodes in the last six months
|
|
| ExclusionCriteria |
| Details |
Individuals below 3 years and above 16 years
Severe and Complicated respiratory allergic disorders like Bronchitis Pneumonia Tuberculosis
Emphysema Lung abscess Bronchiectasis
Patients who are diagnosed as Chronic asthma
Nasal polyposis
Congenital anomalies related to the respiratory system
Patients on inhaled or systemic steroids
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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of respiratory tracrt infections cough cold immunomodulation frequency of cough cold nasal discharge fever |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in laboratory parameters improvement in hospitalization during treatment phase |
12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
This study an open label non comparative and prospective trial will be conducted to evaluate the efficacy and safety of Balrasayana syrup doses decided according to age and weight of chilldren in 3 to 16 years as an immunomodulator and its role in recurrent respiratory tract infections primary outcome measures will be improvement in symptoms of respiratory tract infections at 6 weeks the secondary outcome will be improvement in time recovery and hospitalisation during the treatment phase at 12 weeks |