| CTRI Number |
CTRI/2025/03/082116 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to reduce the symptoms of Kasa Roga in children with Balachaturbhadra churna. |
|
Scientific Title of Study
|
A clinical study on Kasa roga in children with Balachaturbhadra churna |
| 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 Urmila Bariha |
| Designation |
2nd year PG Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya and hospital |
| Address |
Post graduate Department of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya VIP road Puri
Puri
ORISSA
752002
India |
| Phone |
7077185584 |
| Fax |
|
| Email |
urmilabariha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangita Prusty |
| Designation |
Reader and H.O.D, Department of Kaumarbhritya |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya and Hospital |
| Address |
Post graduate Department of OPD and IPD of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya VIP road Puri
Puri
ORISSA
752002
India |
| Phone |
7008329522 |
| Fax |
|
| Email |
prustydrsangita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangita Prusty |
| Designation |
Reader & H. O. D, Department of Kaumarbhritya |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya And Hospital |
| Address |
Post graduate Department of OPD and IPD of Kaumarbhritya Gopabandhu Ayurveda Mahavidyalaya VIP road Puri
Puri
ORISSA
752002
India |
| Phone |
7008329522 |
| Fax |
|
| Email |
prustydrsangita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda Mahavidyalaya and Hospital, Puri
VIP Road, Odisha
Pin-752002 |
|
|
Primary Sponsor
|
| Name |
Dr Urmila Bariha |
| Address |
Post Graduate department of Kaumarbhritya
Gopabandhu Ayurveda Mahavidyalaya and Hospital, Puri
ODISHA Pin 752002 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Urmila Bariha |
Gopabandhu Ayurveda Mahavidyalaya and Hospital, puri |
PG department of Kaumarbhritya
Gopabandhu Ayurveda Mahavidyalaya and Hospital, puri
VIP road, ODISHA Pin-752002
Puri
ORISSA |
07077185584
urmilabariha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gopabandhu Ayurveda Mahavidyalaya and Hospital VIP Road PURI 752002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J06||Acute upper respiratory infections. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of vataja, pittaj and kaphaja kasa roga.
Those who have not received any medication for cough and cold in last 24 hours. |
|
| ExclusionCriteria |
| Details |
1-patient less than 4 year of age & above 12 year.
2-khsyataja and khsyaja kasa
3- kasa associated with fever, bronchial asthma, TB, severe lower RTI.
4- History of malignancy or any other congenital, anatomical abnormalities of chest & respiratory system.
5-kasa associated with severe malnutrition
6- kasa associated with neurological disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the classical symptoms of Kasa and study the efficacy of drug Balachaturbhadra churna. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the classical symptoms of Kasa roga. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/03/2025 |
| 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="0"
Months="0"
Days="14" |
|
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
|
Respiratory complaints are well defined condition in medical science and cough is the most common complain among them.Kasa roga seems to be very simple disease but if it is neglected or mismanaged it may result in disease with poor prognostic condition. The drug Balachaturbhadra churna has maximum ingredients having kapha-pitta samaka properties and also tetracyclic triterpenes,Tannic acid of karkatashringi & ativisa has antioxidant properties, rotundone of Musta have anti-inflammatory, hepatoprotective, anti-pyretic properties, Pippali has many properties, including being acrid, stimulant, appetizer,anti-oxidant, and anti-tussive,that helps in easy expectoration. Thus, I expect Balachaturbhadra churna may be helpful in curing the disease and will be beneficial to society. |