| CTRI Number |
CTRI/2023/10/058881 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
08/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study to Assess the Effectiveness of Peruka Churna Pratisarana in the Management of Mukhapaka in Children |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the
Efficacy of peruka churna pratisarana in 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 Deepthi B Rao |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College Vidyagiri Moodbidri |
| Address |
OPD Department of Kaumarabhritya Alvas Ayurveda Medical College And Hospital, Moodbidri
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8971924309 |
| Fax |
|
| Email |
deepthiraob923@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sogi P George |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Alvas Ayurveda Medical College Vidyagiri Moodbidri |
| Address |
OPD Department of Kaumarabhritya Alvas Ayurveda Medical College And Hospital, Moodbidri
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9447287775 |
| Fax |
|
| Email |
drsogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Deepthi B Rao |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College Vidyagiri Moodbidri |
| Address |
OPD Department of Kaumarabhritya Alvas Ayurveda Medical
College And Hospital, Moodbidri
Dakshina Kannada
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8971924309 |
| Fax |
|
| Email |
deepthiraob923@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College And Hospital, Moodbidri |
|
|
Primary Sponsor
|
| Name |
Dr. Deepthi B Rao |
| Address |
Alvas Ayurveda Medical College Vidyagiri Moodbidri |
| 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 Deepthi B Rao |
Alvas ayurveda medical college and hospital |
OPD Department of kaumarabhritya
Dakshina Kannada
KARNATAKA |
8971924309
deepthiraob923@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee, Alvas Ayurveda Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K121||Other forms of stomatitis. Ayurveda Condition: Mukhapaka, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: khadira churna, Reference: sushruta chikitsa 22nd chapter, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: peruka churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, 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 |
1. Patients of either gender aged between 10 to 16 years.
2. Patient fulfilling the diagnostic criteria of mukhapaka will be selected.
|
|
| ExclusionCriteria |
| Details |
1. Children with congenital anomalies.
2. Children with other systemic illness.
3. Traumatic ulcers and infective stomatitis are 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 |
1. Assessment will be made on the basis of improvement in the clinical
features.
2. Patients will be assessed as per the subjective and objective parameters
made for the study.
Subjective
a. Vyatha
b. Daha
c. Lala srava atyartha
Objective
a. Vrana sankhya
b. Vrana pramana |
14days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral hygiene |
14days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| Date of Study Completion (India) |
29/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is randomized, parallel group, actively controlled clinical study with comparative standard study- Khadira churna and interventional drug- Peruka churna with the dosage of 6gm in 3 divided doses. The study is conducting on patients of Mukhapaka belongs to age of 10years to 16years who gives written and verbal consent by parents for undergoing clinical Study. Study will be conducting in Alvas Ayurveda Medical College And Hospital, Vidyagiri, Moodabidri. Interventional period of this study is 7 days assessment will be done on before treatment, 3rd day, 7th day and followup on 14th day. |