| CTRI Number |
CTRI/2022/03/040942 [Registered on: 09/03/2022] Trial Registered Prospectively |
| Last Modified On: |
18/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of kantakaryadi churna and talisadi churna in management of wet cough in children . |
|
Scientific Title of Study
|
A clinical study to compare the efficacy of kantakaryadi churna and talisadi churna in the management of kaphaja kasa in balya avastha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDakshata anil damare |
| Designation |
PG Scholar |
| Affiliation |
D.Y.PATIL DEEMED TO BE UNIVERSITY |
| Address |
department of kaumarbhritya -balrog,school of ayurveda ,D.Y.Patil deemed to be university,nerul,navi mumbai ,maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
8850928553 |
| Fax |
|
| Email |
dakshatadamare33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dakshata anil Damare |
| Designation |
PG Scholar |
| Affiliation |
D.Y.PATIL DEEMED TO BE UNIVERSITY |
| Address |
department of kaumarbhritya -balrog,school of ayurveda ,D.Y.Patil deemed to be university,nerul,navi mumbai ,maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
8850928553 |
| Fax |
|
| Email |
dakshatadamare33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMithila Amin |
| Designation |
Associate professor |
| Affiliation |
D.Y.PATIL DEEMED TO BE UNIVERSITY |
| Address |
department of kaumarbhritya -balrog,school of ayurveda ,D.Y.Patil deemed to be university,nerul,navi mumbai ,maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9969947997 |
| Fax |
|
| Email |
vaidya.mithila@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of ayurveda D.Y.Patil Deemed to be University, Nerul,NaviMumbai |
|
|
Primary Sponsor
|
| Name |
Dr Dakshata Anil Damare |
| Address |
School of Ayurveda,D.Y.Patil Deemed to be university, Nerul ,Navimumbai. |
| 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 |
| drdakshata anil damare |
D.y.patil deemed to be university |
1st floor, kaumarbhritya OPD no 7, kaumarbhritya -balrog,school of ayurveda ,D.Y.Patil deemed to be university,nerul,navi mumbai ,maharashtra
Thane
MAHARASHTRA |
8850928553
dakshatadamare33@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J22||Unspecified acute lower respiratory infection. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TALISADI CHURNA , Reference: CHARAK CHIKITSA , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 9 Days, anupAna/sahapAna: Yes(details: HONEY), Additional Information: BY CLARK RULE :
(adult dose/68 )*weight =pediatric dose
10-20kg =2.5gm bd
20-30kg = 4gm bd
30-40kg = 6gm bd | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KANTAKARYADI CHURNA , Reference: VRUDDHA NIGANTU, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 9 Days, anupAna/sahapAna: Yes(details: -), Additional Information: BY CLARK RULE :
(adult dose/68 )*weight =pediatric dose
10-20kg =2.5gm bd
20-30kg = 4gm bd
30-40kg = 6gm bd |
|
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)patients with age group 5 to 12years will be taken.
2)patients will be selected irrespective of sex, religion,socioeconomic status and geographical distribution.
3) uncomplicated kaphaja kasa patients will be selected.
4)kasa of less than 10 days duration will be selected. |
|
| ExclusionCriteria |
| Details |
1)patients presenting with kasa due to complications of other respiratory tract diseases like pneumonia, tuberculosis, bronchial asthma , pulmonary edema , plueral effusion, pharyngeal or laryngeal infections, neoplasm, etc
2)patients with pyrexia of unknown origin
3)patients with irregular followup |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A clinical study to compare the efficacy of kantakaryadi churna and talisadi churna in the management of kaphaja kasa in balya avastha |
0 to 9 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the efficacy of kantakaryadi churna
2)to compare the efficacy of kantakaryadi churna and talisadi churna in the management of kaphaja kasa in balya avastha
3)To propose the mode of action of kantakaryadi churna in kaphaja kasa
4)To propose the mode of action of talisadi churna in kaphaja kasa |
0 to 9 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/03/2022 |
| 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="1"
Months="2"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study is the clinical experimental study for completion under D.Y.PATIL DEEMED TO BE UNIVERSITY
total duration of trail is 1year
TITLE: A clinical study to compare the efficacy of kantakaryadi churna and talisadi churna in management of kaphaja kasa in balya avastha.
STUDY GROUP: Sample size 30 will treated with kantakaryadi churna and 30 will be treated with talisadi churna
STUDY CENTRE : OPD of kaumarbhritya department of school of ayurveda D.Y.PATIL DEEMED TO BE UNIVERSITY NERUL NAVIMUMBA and various medical camps
PG SCHOLAR: Dr. Dakshata Anil Damare
GUIDE : Dr. Mithila Amin |