| CTRI Number |
CTRI/2019/03/018287 [Registered on: 26/03/2019] Trial Registered Prospectively |
| Last Modified On: |
25/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A COMPARATIVE STUDY OF SYRUP KANTAKARI & SYRUP SHUNTHI IN THE TREATMENT OF COMMON COLD IN CHILDREN OF AGE GROUP 3-10 YEARS" |
|
Scientific Title of Study
|
"A COMPARATIVE CLINICAL STUDY OF KANTAKARI SYRUP & SHUNTHI SYRUP IN THE MANAGEMENT OF PRATISHYAYA IN CHILDREN (AGE GROUP 3-10 YEARS)" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradip Dattarao Mutkule |
| Designation |
PG Student |
| Affiliation |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE AKURDI PUNE |
| Address |
PDEAs College of Ayurved and Research Centre,
Sector No 25, Nigadi, Pradhikaran Pune
Ayurved Rugnalaya and Sterling multi-speciality hospital,
sector no 27, Pradhikaran
Pune
MAHARASHTRA
411044
India |
| Phone |
9970924401 |
| Fax |
|
| Email |
dr.pdmutkulepatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Sanjay Deodas |
| Designation |
HOD and Guide (Dept. Of Kaumarbhritya) |
| Affiliation |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE AKURDI PUNE |
| Address |
PDEAs College of Ayurved and Research Centre,
Sector No 25, Nigadi, Pradhikaran, Pune
Ayurved Rugnalaya and Sterling multi-speciality hospital,
O.P.D No. 118,
sector no 27, Pradhikaran
Pune
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Sanjay Deodas |
| Designation |
HOD and Guide (Dept. Of Kaumarbhritya) |
| Affiliation |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE AKURDI PUNE |
| Address |
PDEAs College of Ayurved and Research Centre,
Sector No 25, Nigadi, Pradhikaran, Pune
Ayurved Rugnalaya and Sterling multi-speciality hospital,
O.P.D No. 118,
sector no 27, Pradhikaran
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre,
Sector No 25, Nigadi, Pradhikaran, Pune 44
|
|
|
Primary Sponsor
|
| Name |
CARC NIGADI Pune |
| Address |
Sector No 25, Nigadi, Pradhikaran Pune 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 PRADIP DATTARAO MUTKULE |
Ayurved Rugnalaya and Sterling Multispeciality Hospital |
OPD No 118,ground floor, Ayurved Rugnalaya and sterling multispeciality hospital
sector 25, NIGADI
Pune
MAHARASHTRA |
9970924401
dr.pdmutkulepatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KANTAKARI SYRUP |
KANTAKARI SYRUP is prepared by Kantakari Kwatha as mentioned in Sharangdhara Samhita Madhyam Khanda
Dose - 1ml/kg/day
Administration - Oral route
Frequency - three times in a day
Total duration-7days |
| Comparator Agent |
SHUNTHI SYRUP |
SHUNTHI SYRUP is prepared by SHUNTHI Kwatha as mentioned in Sharangdhara Samhita Madhyam Khanda.
Dose - 1ml/kg/day
Administration - Oral route
Frequency - three times in a day
Total duration-7days
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
a. Children between the age group of 3 to 10 years irrespective of gender, religion, socio-economic status.
b. Patients presenting with symptoms of all types of pratishyaya mentioned in ayurveda.
c. History of symptoms of pratishyaya within 7 days. |
|
| ExclusionCriteria |
| Details |
a. K/C/O Chronic infections like bronchial asthama and tuberculosis.
b. K/C/O other infections like bronchitis, pneumonia, sinusitis, tonsillitis.
c. Raktaj pratishayaya.
d. Congenital anamolies related to respiratory system. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and study the efficacy of Kantakari Syrup and Shunthi Syrup in the management of Pratishyaya. |
7 days with follow up on 3rd 5th and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Kantakari syrup.
To study the efficacy of Shunthi Syrup.
To study adverse effect if any |
7 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pratishyaya is the most important disease among respiratory symptoms. Its prevalance rate is almost 40 % of population in pediatric clinic. Nowadays due to climatic changes , air pollution,water pollution most of the population are suffering from pratishyaya all over the world. Also poor immune system and minute etiological factors causes pratishyaya in some aspects. In modern science pratishayaya can be co related with rhinitis. In Rhinitis mucous membrane becomes infected producing a discharge congestion and swelling of the tissue. As modern medicines like antihistaminics and decogesants have many adverse side effects, there is a need to search new ayurvedic drug on pratishyaya. The main objective of this research work is to provide Consolidated report on traditional uses of Kantakari and Shunthi on Pratishaya. |