| CTRI Number |
CTRI/2023/01/048840 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Dadimadi Churna in the management of Peenasa |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Dadimadi Churna in the management of Peenasa (Chronic Rhinitis) in 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 Saurabh Raosaheb Mhaske |
| Designation |
MD Scholar |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 |
| Address |
OPD NO 1 Kaumarbhritya Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011286293 |
| Fax |
|
| Email |
mhaskesaurabh33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Rajpal |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 |
| Address |
OPD NO 1 Kaumarbhritya Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9922037201 |
| Fax |
|
| Email |
ravirajpal24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Rajpal |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 |
| Address |
OPD NO 1 Kaumarbhritya Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9922037201 |
| Fax |
|
| Email |
ravirajpal24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram
Nagar,Pimpri,Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr. Saurabh Mhaske |
| Address |
OPD NO 1 Kaumarbhritya Dr.D.Y.Patil College of Ayurved and Research Centre,Sant Tukaram Nagar,Pimpri,Pune 411018 |
| 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 |
| Saurabh Mhaske |
Dr.D.Y.Patil college of Ayurved and Research Centre,Sant Tukaram Nagar,pimpri,pune 411018 |
OPD No 1 Kaumarbhritya Dr.D.Y.PATIL College Of Ayurved and
Research Centre,Sant Tukaram Nagar,Pimpri,Pune411018
Pune
MAHARASHTRA |
9011286293
mhaskesaurabh33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC COMMITE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadimadi Churna , Reference: Baltantra, Route: Oral, Dosage Form: Churna/ Powder, Dose: 0.92(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: - Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
The patients having at least 2 – 3 symptoms of Peenasa are as follows-
Nasastrava,Frequency of Kshavathu ,Nasavarodha, Nasakandu and Shirashoola.The patients of age from 3 year to 12 years.
The patients who separents are ready to participate in the clinical trial by giving informed written consent. |
|
| ExclusionCriteria |
| Details |
Patients and his/her parents/guardian not willing for trial.Patients having life threatening illness and who is bedridden.Patient who need surgical and other intervention.Patients presenting with symptoms of Dushta Peenasa/ Pratishyaya and Raktaga.Patients suffering with other Nasal diseases like Nasal Polyps, Nasal Septum
Patients associated with Nasal Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms of Peenasa |
7 day study , 0th,3rd ,7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of Dadimadi Churna |
7 day study , 0th,3rd ,7th day |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
15/03/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single arm clinical study in which medicine Dadimadi Churna will be provided to 36 patients showing classical sign and symptoms of Peenasa for releving symptoms . The study will be between the age group of 3 years to 12 years . Dose will be calculated by youngs formula ,follow up on 3rd day and 7th day |