| CTRI Number |
CTRI/2025/07/090749 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Application Of Medicated Powder On Mouth Ulcer In Children |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Darvyadi Churna Pratisarana In The Management Of Mukhapaka 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 M Shriraksha Bangera |
| Designation |
Pg Scholar |
| Affiliation |
Alvas Ayurveda Medical College And Hospital |
| Address |
Alvas Ayurveda Medical College And Hospital , Vidyagiri, Moodubdire, Dakshina Kannada , Karnataka, Department Of Kaumarabhritya, OPD No. 2, ground floor
Alvas Ayurveda Medical College And Hospital, vidyagiri moodubidire karnataka 574277 department of kaumarabritya
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9606874764 |
| Fax |
|
| Email |
mshrirakshab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jithesh Chowta |
| Designation |
Associate professor |
| Affiliation |
Alvas Ayurveda Medical College And Hospital |
| Address |
Alvas Ayurveda Medical College And Hospital, vidyagiri, Moodubidire, Dakshina kannada, Karnataka, Department of Kaumarabhritya, OPD room No.2, Ground floor
Alvas Ayurveda Medical College And Hospital, vidyagiri moodubidire, Dakshina Kannada, Karnataka 574227, Department of Kaumarabhritya, OPD No.2 Ground floor
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9164123167 |
| Fax |
|
| Email |
jitheshchowta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jithesh Chowta |
| Designation |
Associate professor |
| Affiliation |
Alvas Ayurveda Medical College And Hospital |
| Address |
Alvas Ayurveda Medical College And Hospital, vidyagiri, Moodubidire, Dakshina kannada, Karnataka, Department of Kaumarabhritya, OPD room No.2, Ground floor
Alvas Ayurveda Medical College And Hospital vidyagiri moodbidre
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9164123167 |
| Fax |
|
| Email |
jitheshchowta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College And Hospital, Vidyagiri, Moodubidire, Dakshina kannada, Karnataka, India- 574227 |
|
|
Primary Sponsor
|
| Name |
Dr M Shriraksha Bangera |
| Address |
Alvas Ayurveda Medical College And Hospital vidyagiri
Moodubidire Dakshina kannada Karnataka India 574277
Dakshina Kannada
Karnataka |
| 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 M Shriraksha Bangera |
Alvas Ayurveda Medical College And Hospital |
Department Of Kaumarabhritya, OPD room no. 2, Ground floor,Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka -574277
Dakshina Kannada
KARNATAKA |
09606874764
mshrirakshab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadira churna, Reference: Sushrutha samhita chikitsa sthana, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi churna, Reference: Chakradatta Balarogaadhikara, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender aged between 10 to 16 years
Patient fulfilling the diagnostic criteria of Mukhapaka will be selected |
|
| ExclusionCriteria |
| Details |
Children with congenital anomalies
Children with other systemic illness
Infective stomatitis and any malignant conditions will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the average number and size of the ulcer before and after treatment in two groups and to compare pain, burning sensation and excess salivation before and after treatment in the two groups. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the repeated occurance
of ulcers |
14 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/08/2025 |
| 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="15" |
|
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
|
The study is randomized, parallel group, actively controlled comparative clinical study with Khadira churna as standard drug and Darvyadi churna as interventional drug which is applied over the ulcer in the quantity sufficient dosage, three times in a day before food for a period of 7 days. The study will be conducted on subjects having Mukhapaka belonging to the age group of 10 to 16 years who has given written and verbal consent by parents for undergoing clinical study. The study will be conducted in Alvas Ayurveda Medical College And Hospital, Moodubidire. Interventional period of the study is 14 days and assessment will be done before treatment, 3rd , 7th and 14th day. |