| CTRI Number |
CTRI/2024/10/075440 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing The Efficacy of Polyherbal Lotions in the Management of Mouth Ulcers in Children |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Modified Dosage form of Krushna Jeerkadi Yoga (Lotion) vs Mrudivkadi Lotion in Children with Stomatitis (Mukhapaka)- A Randomized Controlled Trial |
| 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 Parag Rajendra Bodke |
| Designation |
PG-Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H)
Wardha.
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370506005 |
| Fax |
|
| Email |
paragbodke11@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul M Jumle |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H)
Wardha.
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766643990 |
| Fax |
|
| Email |
rahul.jumle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parag Rajendra Bodke |
| Designation |
PG-Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H)
Wardha.
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370506005 |
| Fax |
|
| Email |
paragbodke11@outlook.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H),
Wardha
Dist- Wardha
Maharashtra,
India
442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College, Hospital and Research Centre |
| Address |
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H)
Wardha.
MAHARASHTRA
442001
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Parag Rajendra Bodke |
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H)
Wardha.
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA |
9370506005
paragbodke11@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Institutional Committee, Salod(H) Wardha, Maharashtra 442001 |
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: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krushna Jeerkadi Churna, Reference: Chakradatta, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mrudvikadi Pratisaran, Reference: BhaishjyaRatnavali ChikitsaSthana. 61/83-87, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical signs and symptoms of Stomatitis, such as pain, irritability, ulceration, and excessive salivation.
2. Patients with a baseline severity score indicating mild to moderate Stomatitis on the WHO stomatitis grading scale
3. Whose Parents are willing to sign Written Informed Consent.
4. Patients will be included irrespective of age, gender, race, religion and socioeconomic status. |
|
| ExclusionCriteria |
| Details |
1. Children with severe stomatitis require immediate intensive medical intervention.
2. Children who have received treatment for stomatitis within the last two weeks.
3. Families unwilling or unable to comply with study requirements.
4. Children with autoimmune conditions leading to stomatitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from signs and symptoms of Stomatitis (Mukhapaka) as pain, irritability, burning sensation, excessive salivation. |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral intake will be increased |
7-14 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/11/2024 |
| 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="2"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer computer-generated table. The clinical research format will be prepared and validated. Before the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups. The trial is a Randomized standard Control Superiority Clinical Trial. it will include a 7-day treatment period and, after 7 days, follow-up period. |