CTRI Number |
CTRI/2019/05/019482 [Registered on: 31/05/2019] Trial Registered Prospectively |
Last Modified On: |
31/05/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Crossover Trial |
Public Title of Study
|
To Study The Efficacy Of Kataphaladi Syrup In Pratishaya With Special Reference To Allergic Rhinitis In Children. |
Scientific Title of Study
|
AN EXPLORATORY CLINICAL STUDY TO EVALUATE THE EFFICACY OF KATAPHALADI SYRUP IN PRATISHYAYA IN THE CHILDREN. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rahul Ingole |
Designation |
PG Scholar |
Affiliation |
College of Ayurveda And Research Center, Nigdi, Pune |
Address |
College of Ayurveda And Research Center, Nigdi,Pune
Pune MAHARASHTRA 411044 India |
Phone |
9890376572 |
Fax |
|
Email |
rahulingole26@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sudha singh |
Designation |
Guide; Md (Kaumarbhritya) |
Affiliation |
College of Ayurveda And Research Center, Nigdi, Pune |
Address |
College of Ayurveda And Research Center, Nigdi,Pune
Pune MAHARASHTRA 411044 India |
Phone |
9975404439 |
Fax |
|
Email |
drsudha2010@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rahul Ingole |
Designation |
PG Scholar |
Affiliation |
College of Ayurveda And Research Center, Nigdi, Pune |
Address |
College of Ayurveda And Research Center, Nigdi,Pune
Pune MAHARASHTRA 411044 India |
Phone |
9890376572 |
Fax |
|
Email |
rahulingole26@gmail.com |
|
Source of Monetary or Material Support
|
PDEAS College of Ayurveda And Research Centre,Nigdi Pune44 |
|
Primary Sponsor
|
Name |
CARC nigdiPune |
Address |
Nigdi pradhikaran sector 25 Pune 44 |
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 Rahul Ingole |
Kaumarbhritya OPD/IPD of Ayurveda General And Sterling Multi speciality Hospital, Nigdi, Pune |
Sector 27, Sant Dyaneshwar Chowk, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044 Pune MAHARASHTRA |
9890376572
rahulingole26@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: B998||Other infectious disease, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Kataphaladi Syrup |
kataphaladi syrup will be given orally to the children in between 3 to 12 yeas of age of the dose is calculated by clarks rule which is 1mg/kg/day and will be given 3 times in aday for 7 days/10days which include follow up 0, 3rd,5th,7thand 10th day. |
Comparator Agent |
Nil |
Not Applicable |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
1.Sign and symptoms of pratishtha mentioned in Ayurveda classics and allergic rhinitis according to modern texts.
2.pratishyaya of recent onset within one week |
|
ExclusionCriteria |
Details |
1.Asthma,sinusitis, infectious disease like T.B. and other systematic disorders which interfere in the treatment.
2.Congenital anomalies related to respiratory system. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To study the efficacy of kataphaladi syrup in pratishyaya. |
7 days/10 days with follow up at 0,3rd,5th,7th day and 10 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To study the disease pratishaya both in Ayurveda and modern parlance
2.To evaluate the adverse effects if any. |
7 days/10days with follow up at 0,3rd,5th,7th days and 10 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
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
|
05/06/2019 |
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="6" 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
|
Allergic rhinitis is one of the frequently troubling conditions especially in children. The symtoms of allergic rhinitis shows resemblance with the lakshanas of Pratishaya explained in ayurvedic classics.Pratishyaya is one of the disease in the which inflammation of mucous membrane of the nose is observed.In the management of pratushyaya in children needs more care and observation since the complication can make the condition adverse in the stage of its prognosis.If disease is not treated properly or neglected,it may cause complication like kasa. so, there is need for more effective treatment to eradicate this problem from root base.Ayurveda has potent herbal medicines possessing Aampachaka, immune modulatory antiallergic,anti-inflammatory and mucolytic effect which can be used for breacking the pathology of the disease at various levels and giving prompt symptomatic relief to the patient. Hence,the simple preparation Kataphaladi syrup which is having capacity of giving relief in pratishyaya as permentioned in classical Ayurvedic text is selected to find out its efficacy in management of pratishyaya in children. Kataphaladi syrup will be given orally in the dosage of 1ml/kg/day as per Clark’s formula according to the weight divided 3times in a day for 10days. |