| CTRI Number |
CTRI/2024/10/074734 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to assess the efficacy of Jatipatradi kwath gandusha in management of Pittaj Mukhapaka with special Reference to Aphthous Stomatitis |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Jatipatradi kwath gandusha in Pittaj Mukhapaka with special reference to Aphthous Stomatitis |
| 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 Vrushali EknathTandale |
| Designation |
PG Schloar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital, PGT And RC Islampur. |
| Address |
Opd no 10 Shalakyatantra Department, LRP Ayurvedic medical college and hospital,PG Institute and Research center, Urun Islampur.
Sangli
MAHARASHTRA
415409
India |
| Phone |
8600720510 |
| Fax |
|
| Email |
dr.vrushali.tandale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Walvekar |
| Designation |
Associate professor |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center, Urun Islampur Sangli |
| Address |
OPD no 10 Shalakyatantra Department, LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur Sangli
MAHARASHTRA
415409
India |
| Phone |
9822442719 |
| Fax |
|
| Email |
sunilwalvekar99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrushali EknathTandale |
| Designation |
PG Schloar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital, PGT And RC Islampur. |
| Address |
Opd no 10 Shalakyatantra Department, LRP Ayurvedic medical college and hospital PG Institute and Research center, Urun Islampur.
Sangli
MAHARASHTRA
415409
India |
| Phone |
8600720510 |
| Fax |
|
| Email |
dr.vrushali.tandale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete rajarambapu ayurvedic medical college hospital post graduate institute and research centre Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Vrushali Eknath Tandale |
| Address |
Loknete rajarambapu ayurvedic medical college hospital post graduate institute and research centre Islampur 415409 |
| 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 Vrushali Eknath Tandale |
LRP ayurvedic medical collage hospital post graduate institute and research center Islampur |
LRP Ayurvedic medical college and hospital, PG Institute and Research center, Urun Islampur 415409,Shalakyatantra OPD.
Sangli
MAHARASHTRA |
8600720510
dr.vrushali.tandale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee LRP Ayurvedic medical college and hospital and PCT and RC Approved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: PITTAJA-SARVASARA-MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatipatradi Kwath , Reference: Bha Pra 66/157, Route: Topical, Dosage Form: Churna/ Powder, Dose: 72(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Orasep Gel | Medicine Name: Orasep gel , Dose: 15ml , Route: Topical , Frequency: repeated every 3 to 4 hours , Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient willing to sign written concent.
2) irrespective of gender, religion, occupation, socioeconomic status will be selected randomly for the study.
3) Patient having signs & symptoms ofPittaj mukhapaka - Ruja, Toda, Daha, Raktavarnata, Sphota. |
|
| ExclusionCriteria |
| Details |
1) Inflammatory condition of the oral cavity like gingivitis, pharyngitis, tonsillitis.
2) Traumatic injury of mouth(e.g. Tooth brush, jagged teeth).
3) Patient suffering from allergic stomatitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Aphthous
Stomatitis |
7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To reduce the redness
2)To reduce the ulceration |
7 days
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
05/10/2024 |
| 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="1"
Months="6"
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
|
Todays life we live luxurious lifestyle which leads to many health problems, mukhapaka is one of them pain redness of mouth, ulcer, burning sensation,inflamation of mouth disturbs our daily routine. There are many treatment formulations about mukhapaka mentioned in ayurveda. This is Randomized Controlled Clinical Trial To Evaluate The Effect Of Jatipatradi Kwath Gandusha In Pittaj Mukhapak With Special Reference To Aphthous Stomatitis. Jatipatra Kwath contains Tridoshahar, Pittashamak, Vranaropak, Dahshamak,Vednashamak properties. Jatipatradi Kwath Gandush and Oracep Gel in Pittaj Mukhapaka for 7 days cheak the healing and recurrence of it. This can be safe and cost effective alternative to the conventional treatment which is usefull in country like India.
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