| CTRI Number |
CTRI/2025/02/080363 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A comparative clinical study of Darvyadi choorna lepa and Khadiradi vati in the management of Mouth Ulcer (Stomatitis) in children. |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of Darvyadi choorna lepa and Khadiradi vati 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 Sibani Misra |
| Designation |
MD scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved college Raipur |
| Address |
Department of Kaumarbhritya OPD No. 07 and IPD Patients Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattishgarh
Raipur
Chhatisgarh
492010
India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9938627438 |
| Fax |
|
| Email |
sibnimishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Neeraj Agrawal |
| Designation |
Professor and HOD |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved college Raipur |
| Address |
Department of Kaumarbhritya Shri Narayan Prasad Awasthi govt Ayurved college Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9109923485 |
| Fax |
|
| Email |
dr_neeraj2001in@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyawati Rathia |
| Designation |
Lecturer |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved college Raipur |
| Address |
Department of Kaumarbhritya Shri Narayan Prasad Awasthi govt Ayurved college Raipur Chhattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9924975823 |
| Fax |
|
| Email |
satirathiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarabhritya Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department of Kaumarbhritya Shri Narayan Prasad Government Ayurved College Raipur |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chattisgarh 492010 |
| Type of Sponsor |
Other [Government Ayurved College, Raipur] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chattisgarh |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sibani Misra |
Shri Khudadad Doongaji Government Ayurved Hospital Raipur |
OPD No.07 and IPD
Department Of Kaumarbhritya Shri Khudadad Doongaji
Government Ayurved Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH |
9938627438
sibnimishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Government Ayurved College Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K123||Oral mucositis (ulcerative). Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadiradi Vati, Reference: Bhaisajya ratnavali chapter no 61 sloka no 96 and 97, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Darvyadi Choorna Lepa, Reference: Bhaisajya ratnavali chapter no 71 sloka no 84, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children possessing classical sign and symptoms of Mukhapaka (Mouth ulcer).
2.Patient between the age group of 3 year to 12 year were selected for the study and selected randomly irrespective of sex, religion and socioeconomic status.
|
|
| ExclusionCriteria |
| Details |
1.Patient suffering from serious systemic illness which may interfere with course of treatment.
2.Patient having non healing chronic ulcer, malignancy and syphilis etc.
3.Age below 3 year and above 12 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain inflammation and healing ulcer |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improve the Quality of life
boost Immunity |
7 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)
|
01/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF DARVYADI CHOORNA LEPA AND KHADIRADI VATI IN THE MANAGEMENT OF MUKHAPAKA IN CHILDREN
Mukhapaka is painful condition of Mukha. Mukhapaka is very common in children. Mukhapaka occur due to unhygienic condition of mouth, gastritis, constipation, infection, vitamin B complex deficiency, spicy and oily food etc. Darvyadi choorna lepa is indicated in Bhaisajya-ratnavali for Mukhapaka under Balarogadhikar while Khadiradi vati is indicated in Bhaisajya-ratnavali for mukharoga, danta roga, austha roga, jihva roga & talu roga under Mukharogadhikar. Need of study is detailed clinical evaluation of Mukhapaka (Mouth ulcer) in children. Aim is to compare the efficacy of Darvyadi choorna lepa and Khadiradi vati in the management of Mukhapaka (Mouth ulcer). Darvyadi choorna lepa contents are daruharidra, mulethi, haritaki, jatipatra and madhu. Khadiradi vati contents are Khadira, Javitri, Karpura, Sitalachini, Puga and Jatiphala. Study design is Open interventional non-randomized double arm clinical study. Description of the population is 3-to-12year age group affected with Mukhapaka. Total no. of patient is 40 (divided in 2 groups). Children possessing classical sign and symptoms of Mukhapaka (Mouth ulcer). Inclusion criteria is children possessing classical sign and symptoms of Mukhapaka (Mouth ulcer). Exclusion criteria is patient suffering from serious systemic illness which may interfere with course of treatment. |