| CTRI Number |
CTRI/2025/04/085791 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| 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 Panchakoladi Churna in decreasing recurrent nasal discharge in children age 2 year to 12 years. |
|
Scientific Title of Study
|
Evaluation of the Efficacy of Panchakoladi Churna in Peenasa (Rhinitis) in Children |
| 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 Unmesh Khushalgir Gosavi |
| Designation |
MD Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD No.1 and IPD Kaumarbhritya Department, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8600484367 |
| Fax |
|
| Email |
gosaviunmesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Rajpal |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD No.1 and IPD Kaumarbhritya Department, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9922037201 |
| Fax |
|
| Email |
ravirajpal24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Rajpal |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD No.1 and IPD Kaumarbhritya Department, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
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, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Unmesh Khushalgir Gosavi |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar,Pimpri, Pune Maharashtra 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 |
| Dr Unmesh Khushalgir Gosavi |
Dr. D. Y. Patil College of Ayurved and Research Centre |
OPD & IPD, Kaumarbhritya
Department, Dr. D. Y. Patil
College of Ayurved and
Research Centre, Sant
Tukaram Nagar, Pimpri,
Pune Maharashtra 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8600484367
gosaviunmesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA & RC INSTITUTIONAL ETHICS COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PINAS, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PANCHAKOLADI CHURNA , Reference: ASTANGA SAMGRAHA BY PROF JYOTIR MITRA CHOUKHAMBA SURABHARTI PUBLICATION VARANASI UTTARASTHANA CHAPTER NO 2 SHLOK NO 56 AND GADA NIGRAHA KAYACHIKITSA KHANDA KAUMARTANTRA BALROGADHIKAR CHAPTER NO 11 SHLOK NO 112, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients having at least 2 – 3 symptoms of Peenasa are as follows-
a.NASASTRAVA (Rhinorrhea)
b.KSHAVATHU (Sneezing)
c.NASAVARODHA (Nasal congestion)
d.NASAKANDU (Itching in nose)
e.SHIRASHOOLA (Headache)
2.The patients of age from 2 year to 12 years.
3.The patients who’s parents are ready to participate in the clinical trial by giving informed written consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients and his/her parents/guardian not willing for trial
2. Patients known case of any major chronic illness and any congenital anomalies .
3. Patient who need surgical and other intervention
4. Patients presenting with symptoms of Dushta Peenasa/ Pratishyaya and Raktaga Pratishyaya
5. Patients suffering with other Nasal diseases like Nasal Polyps, Deviated Nasal Septum
6. 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 |
| The Symptoms Of Peenasa Are Expected To Be Reduced After The Use Of Panchakoladi Churna In Childrens. |
07 days study with follow up on 03rd and 07th day (0,03,07 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect of Panchakoladi Churna ,if any |
07 days study with follow up on 03rd and 07th day (0,03,07 days) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 single arm clinical study in which the medicine "Panchakoladi Churna " will be provided to 45 patients showing sign and symptoms of Peenasa (Rhinitis). The age group taken for the study trial will be in between 2 years to 12 years. Panchakoladi Churna with Madhu will be given on 0th day thrice a day for 07 days. Dose will be calculated by age formula.
Follow up will be done on 3rd and 07th day and the total duration of case study will be 07 days. The final conclusion will be drawn on the basis of statistical methods |