| CTRI Number |
CTRI/2025/01/078967 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the difference between the effect of the paushakardi syrup and balchaturbhadra syrup in the management of kaphaj kasa in children |
|
Scientific Title of Study
|
A comparative clinical study between the efficacy of the paushakardi syrup and balchaturbhadra syrup in the management of kaphaj kasa in children of age group 5-10 years |
| 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 Rutuja Ramchandra Patil |
| Designation |
MD scholar Kaumarbhrityatantra |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
07249181103 |
| Fax |
|
| Email |
rutujapatil11398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramchandra Pandurang Babar |
| Designation |
Professor of department of Kaumarbritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8275459236 |
| Fax |
|
| Email |
ramchandrababar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramchandra Pandurang Babar |
| Designation |
Professor of department of Kaumarbritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8275459236 |
| Fax |
|
| Email |
ramchandrababar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kaumarbhritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
411028 |
| 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 Rutuja Ramchandra Patil |
sane guruji arogya kendra |
OPD NO 13 Department of Kaumarbritya
Pune
MAHARASHTRA |
07249181103
rutujapatil11398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J20||Acute bronchitis. Ayurveda Condition: KAPAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Paushkaradi syrup, Reference: Yogratnakar Balrog Chikitsa, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Treatment will be given for 7 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Balchaturbhadra, Reference: Bhishajyakalpana balrogadhikar, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Treatment will be given for 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical signs and symptoms of kaphaj kasa
Mandagni Aruchi Pinasa Asyamadhurya Stivanayuktakasa, Swarabhed, Kanthekandu.
Age group 5 yr to 10 yr
Patients irrespective of sex religion and socioeconomical status
Patient who give written consent will be included.
|
|
| ExclusionCriteria |
| Details |
Kasa other than kaphaj kasa
Kaphaj Kasa associated with jwara
Patient with condition like known case of Pneumonia TB Bronchial Asthma Immunocompromised diseases like Juvenial Diabetes Mellitus will be excluded
4.Patient having any chronic and systemic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of paushakaradi syrup and balchaturbhadra syrup in the management of kaphaj kasa in children of age group 5 to 10 years |
Treatment will be given for 7 days
Paushkaradi syrup will be given for one group and balchaturbhadra syrup will be given for another group .
Follow up and assessment will be done after 3rd 5th and 7th day. Assessment will be done by objective and subjective parameters.
Final observation will be recorded after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
literature study of kaphaj kasa in paediatric age group
to observe adverse effect if any |
Study will be done using Ayurvedic Granthas & modern texts
Preparation of drugs will be done according to standard procedure
During treatment observation will be done on 3rd 5th & 7th day & later adverse effect |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="0"
Days="0" |
|
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
|
This is a comparative clinical study between the efficacy of paushkaradi syrup and balchaturbhadra syrup in the management of kaphaj kasa in children of age group 5-10 years Primary objective is to compare efficacy of paushakaradi syrup and balchaturbhadra syrup orally for 7 consecutive days in kaphaj kasa in children with age group of 5 to 10 years Assesment of signs and symptoms will be done and observation will be drawn from the outcome of patient |