| CTRI Number |
CTRI/2025/08/092772 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Effect Of Ashwathyadi Lep In The Management Of kaphaj, pittaj and vranaj Mukhapak In Childrens of age group 5-16 yrs |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial Of Ashwathyadi Lep In The Management Of Mukhapak In Children Of Age Group 5-16 yrs |
| 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 Ayush Rajendra Dandawate |
| Designation |
PG scholar |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalay And Hospital Kamal Nagar Hirawadi Panchavati Nashik |
| Address |
Department Of Kaumarbhritya OPD No 5 Ground Floor Shree Saptashrungi Ayurved Mahavidyalay And Hospital Kamalnagar Panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9552488462 |
| Fax |
|
| Email |
ayushdandawate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Shankarrao Surse |
| Designation |
HOD |
| Affiliation |
Shree Saptashrungi Ayurveda Mahavidyalay And Hospital Kamal Nagar Hirawadi Panchavati Nashik |
| Address |
Department Of Kaumarbhritya OPD No 5 Shree Saptashrungi Ayurved Mahavidyalay And Hospital Kamalnagar Panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9224297523 |
| Fax |
|
| Email |
drsurseys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Shankarrao Surse |
| Designation |
HOD |
| Affiliation |
Shree Saptashrungi Ayurveda Mahavidyalay And Hospital Kamal Nagar Hirawadi Panchavati Nashik |
| Address |
Department Of Kaumarbhritya OPD No 5 Shree Saptashrungi Ayurved Mahavidyalay And Hospital Kamalnagar Panchavati Nashik
Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9224297523 |
| Fax |
|
| Email |
drsurseys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyalay And Hospital Kamalnagar Panchavati Nashik |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalay And Hospital Kamalnagar Panchavati Nashik 422003 |
| Address |
Department Of Kaumarbhritya OPD No 5 Shree Saptashrungi Ayurved Mahavidyalay And Hospital Nashik 422003, Maharashtra India |
| Type of Sponsor |
Private medical college |
|
|
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 Ayush Rajendra Dandawate |
Shree Saptashrungi Ayurved Mahavidyalay And Hospital Kamalnagar Panchavati Nashik |
Department of Kaumarbhritya, opd no 5, SSAM and H Hirawadi kamal nagar nashik 422003
Nashik
MAHARASHTRA |
9552488462
ayushdandawate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalay Kamalnagar Panchavati Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K120||Recurrent oral aphthae, , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Ashwathyadi lep |
Reference - bharat bhaishajya ratnakar, panchamo bhag, lep prakaran, balroga,shlok no 8898
Dose- 1-2gm churna with madhu according to numbers and size of ulcer
Frequency - Tds
Route of administration- local application
Duration - 7 days
Follow up - 3rd 5th and 7th day
Anupan/sahapan -yes (Madhu) |
| Comparator Agent |
Glycerin (non Ayurveda) |
Dose- 1-2 drops of glycerin (food grade) on each ulcer
Frequency -TDS
Route of administration- - local application
Duration - for 7 days and regular follow up on 3rd, 5th and 7th day |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective of Gender Religion and Socioeconomic condition
Patient with Classical Signs and Symptoms of Kaphaj Pittaj Vranaj Mukhapak |
|
| ExclusionCriteria |
| Details |
Mouth Ulcer due to viral fungal bacterial infection
Patients having or suffering from other diseases or systemic disorders
Patient with HIV, VDRL, HBSAG positive and immunocompromoised patidnt
If thr patients is non co operative |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduced the daha, tod, athyadhik lalastrav, pitavaivarnya,, kandu, aruchi lakshanas |
Outcome will be asses on 3rd, 5th and 7 th day of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check pain & functional status according to visual analogue scale |
Outcome will be asses on 3rd 5th 7th day |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="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
|
Title A Randomized Controlled Clinical Trial of Ashwathyadi Lep in the Management of Mukhapak in Children of age group 5-16 yrs
Primary objective To study the efficacy of Ashwathyadi lep in the Management of Mukhapak in Children 5-16 yrs To compare the effect of local application of Ashwathyadi Lep and glycerin in mukhpak
Secondary objective- To study the ayurvedic literature of mukhpak To study the literature of glycerin Ti study the drug ashwathya and its uses To study th drug ashwathya and ashwathyadi lep from ayurvedic samhitas and to study the preparation of Ashwathyadi lep
Group A and Group B will Respectively give Ashwathyadi lep and Glycerin for local application in mukhpak for 7 days
Clinical assessment will be done on 3 rd, 5th and 7th day
Inclusive criteria School age children (5-16yrs) Irrespective of Gender Religion and Socioeconomic condition Patient with Classical Signs and Symptoms of Kaphaj Pittaj and Vranaj Mukhapak
Exclusive criteria Mouth Ulcer due to viral, fungal, bacterial infection Patient having or suffering from other diseases or systemic disorders Patient with HIV, VDRL, HBSAG positive and immunocompromoised patient If the patient is non co-operative
Withdrawal criteria Patient will be withdrawn from the study if the patient refuses the treatment inspite the consent taken before If the patient is non co-operative If some complications happen If severity of disease increases
Primary outcome Reduce Signs and Symptoms of Mukhapak
Secondary outcome No recurrence of Mukhapak
Patient is observed before and after treatment
Data will be collected using CRF and will be observed in the form of tables and graphs
Data analysis- observed data will be analysis strictly on the basis of statistical analysis
Ethical consideration - the study will be conducted in accordance with ethical guidelines and with informed consent from participants
|