| CTRI Number |
CTRI/2022/03/041429 [Registered on: 28/03/2022] Trial Registered Prospectively |
| Last Modified On: |
24/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of yashtimadhu ghrita application in treatment of mukhapak 9Apthous ulcer) |
|
Scientific Title of Study
|
Comparative clinical trial to study the efficacy of Yashtimadhu Ghrita Application with Zytee mouth gel (Cholinsalicyclate and Benzalkonium chloride) in management of Mukhpaka in Children with special reference to Apthous stomatitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshada Patange |
| Designation |
PG Scholar |
| Affiliation |
Dr. D Y Patil School of Ayurveda, Nerul, Navi Mumbai |
| Address |
Balrog Department,Dr. D. Y. Patil, School Of Ayurveda , Nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
8097037809 |
| Fax |
|
| Email |
harshadajaitpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Dhuri |
| Designation |
Head of the Department |
| Affiliation |
Dr. D Y Patil School of Ayurveda, Nerul, Navi Mumbai |
| Address |
Balrog Department,Dr. D. Y. Patil, School Of Ayurveda , Nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
8097037809 |
| Fax |
|
| Email |
dhurikalpana34@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Dhuri |
| Designation |
Head Of The Department |
| Affiliation |
Dr. D. Y. Patil, School Of Ayurveda |
| Address |
Balrog Department,Dr. D. Y. Patil, School Of Ayurveda , Nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
09321835616 |
| Fax |
|
| Email |
dhurikalpana34@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Balrog, D Y Patil Deemed to be University’ School of Ayurveda.
Sector -7, Nerul, Navi Mumbai – 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Harshada Patange |
| Address |
Balrog Department,Dr. D. Y. Patil, School Of Ayurveda , Nerul |
| 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 Harshada Patange |
School of Ayurveda. |
1 st floor , OPD no. 7, Balrog Department,Dr. D. Y. Patil, School Of Ayurveda , Nerul
Thane
MAHARASHTRA |
8097037809
harshadajaitpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K137||Other and unspecified lesions of oral mucosa. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: yashtimadhu ghruta, Reference: h.s. haritakyadivarga, Route: Oral, Dosage Form: Ghrita, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: local application on mukhapaka | | 2 | Comparator Arm (Non Ayurveda) | | - | zytee mouth paint | medicine name: Zytee mouth paint dose 1gm route oral (local application) dosage form: mouth paint kaal: pragbhakta
frequency : bid
duration 7days
|
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Classical signs and symptoms of Mukhapak such as ulcers, salivation, Irritability (painful
mouth), Difficulty in Mastication and Deglutition.
2. Non infective Stomatitis
3. Both male and female sex.
4. Age group- 5 yr – 12 yr
5. Only those patients will be selected whose parents are willing to give written consent. |
|
| ExclusionCriteria |
| Details |
1. Traumatic stomatitis
2. Infective stomatitis
3. allergic stomatitis.
4. denture stomatitis
5. deep seated mouth ulcer more than 1.5 mm. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of yashtimadhu ghrita application v.s. zytee mouth gel( choline salicyclate and benzalkonium chloride) in management of mukhpak in children |
0 to 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to study the efficacy of yashtimadhu ghrita in mukhapakaw.s.r. to apthous stomatitis.
2. to study the comparative efficacy between yashtimadhu ghrita application w.r.t. zytee
3. to provide scientific base and suitable effective medicine for mukhpak
4. to study mukhpak and aphthous stomatitis theoretically. |
0 to 7 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/04/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the present study is the clinical experimental study for completion under D.Y. Patil Deemed to be university. Total duration of trial is 6 months.
TITLE- Comparative clinical study to assess the efficacy of a Yashtimadhu ghrita Application with Zytee mouth gel ( cholinsalicyclate and Benzalkonium Chloride.) in management of mukhapak in children w.s.r to Aphthous Stomatitis.
STUDY GROUP - SAMPLE SIZE 30 will be treated with Yashtimadhu ghrita and 30 will be treated with zytee mouth gel.
STUDY CENTRE - D.Y.Patil school of Ayurveda , Nerul, Navi mumbai.
PG Scholar- Dr. Harshada Patange.
Guide- Dr Kalpana Dhuri. |