| CTRI Number |
CTRI/2025/04/085071 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| 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
|
A Clinical Study to See The Effect of Mukhapaknashak Yoga in Mukhpaka in childrens |
|
Scientific Title of Study
|
Randomised Control Clinical Trial to Evaluate Efficacy of Mukhapaknashak yog in Mukhpaka 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 Yogiraj Tongale |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate research centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Reseach Centre Ashta Tal Walwa Dist sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9527642344 |
| Fax |
|
| Email |
yogiraj.tongle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Chaugule |
| Designation |
Head Of Department |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Reseach Centre Ashta |
| Address |
4th Floor Department Of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Reseach Centre Ashta Tal Walwa Dist sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9921212722 |
| Fax |
|
| Email |
chaugulemahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Chaugule |
| Designation |
Head Of Department |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Reseach Centre Ashta |
| Address |
4th Floor Department Of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Reseach Centre Ashta Tal Walwa Dist sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9921212722 |
| Fax |
|
| Email |
chaugulemahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Danger Ayurved Medical College and Post Graduate Centre Ashta , Dist Sangli , Maharashtra 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Yogiraj Tongale |
| Address |
OPD No. 5 Balrog OPD Dhanvantari Ayurved Hospital Ashta |
| Type of Sponsor |
Other [] |
|
|
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 Yogiraj Tongale |
Dr Yogiraj Tongale |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanvantari Ayurved Hospital
Sangli
MAHARASHTRA |
9527642344
yogiraj.tongle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K132||Leukoplakia and other disturbancesof oral epithelium, including tongue. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mukhapak-nashak-yog, Reference: vagbhata samhita , Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kamdudha churna, Reference: rasayogasagara ककारादरसा: अयाय, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having signs and symptoms of mukhapak (toda, daha,
raktavarnata, sphota, shopha)
2. Patients between the age group 05 to 12 years, irrespective of
Gender, religion, socio-economic status will be selected randomly
for the study
3. Patient having ulcer dimension less than 4 to 5 mm
4. Recurrent history of stomatitis. |
|
| ExclusionCriteria |
| Details |
1. Traumatic injury of mouth (eg-Toothbrush, jagged teeth)
2. Inflammatory conditions of the oral cavity like gingivitis,
pharyngitis, tonsillitis.
3. Patients duration of course suffering from any systemic illness
which interfere the of duration course i.e. Asthma.
4. Patient having ulcer dimension more than 5 mm.
5. Diseases like handfoot and mouth etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
signs and symptoms of mukhapak like toda, daha,
raktavarnata, sphota, shopha will be decreased, and patient will be relieved from mukhpaka |
0 , 3rd and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NIL
|
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
05/05/2025 |
| 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="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
|
Mukhpak commonest diseases of oral cavity seen in society and affects the
daily routine of person.
The symptoms of mukhpak can be co-related with stomatitis. an effort has
made to study safe, cost effective, easily available drug and which will be
beneficial to patient suffering from this diseases.
Therefore, an effort has made to study of mukhpak-nashak-yog pratisaran
in series of patient suffering from Sarvasar .Also there is no previous work
done on this remedy |