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CTRI Number  CTRI/2024/11/076977 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This clinical trial will be performed to understand the the effect of Triphaldi kashaya gandush in comparison with Tannic acid, Choline Salicylate gel local Application in the management of pittaj mukhapaka which includes symptoms like asya daha, asya ruja, asya vairasya asya vran. 
Scientific Title of Study   Randomized control clinical trial to evaluate the efficacy of Triphaldi kashaya gandush and Tannic acid, Choline Salicylate gel local Application in the management of pittaj mukhapaka  
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 Trupti kishor lawangare 
Designation  PG scholar 
Affiliation  PDEAs College Of Ayurved and Research centre 
Address  PDEAs college of Ayurved and REsearch center 3rd floor shalakyatantra department sector 25 pradhikaran Nigdi pune MAHARASHTRA 411044 India Pune MAHARASHTRA

Pune
MAHARASHTRA
411044
India 
Phone  9145421300  
Fax    
Email  truptilawangare9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Chandana Virkar 
Designation  Professor and HOD shalakyatantra department 
Affiliation  PDEAs College Of Ayurved and Research centre 
Address  PDEAs college of Ayurved and REsearch center 3rd floor shalakyatantra department sector 25 pradhikaran Nigdi pune MAHARASHTRA 411044 India Pune MAHARASHTRA

Pune
MAHARASHTRA
411044
India 
Phone  9822199107  
Fax    
Email  drvirkarchandana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Trupti kishor lawangare 
Designation  PG scholar 
Affiliation  PDEAs College Of Ayurved and Research centre 
Address  PDEAs college of Ayurved and REsearch center 3rd floor shalakyatantra department sector 25 pradhikaran Nigdi pune MAHARASHTRA 411044 India Pune MAHARASHTRA

Pune
MAHARASHTRA
411044
India 
Phone  9145421300  
Fax    
Email  truptilawangare9@gmail.com  
 
Source of Monetary or Material Support  
PDEAs college of ayurved and research centre sector no 25 pradhikaran nigadi pune 411044 
 
Primary Sponsor  
Name  PDEAs college of ayurved and researchg centre 
Address  PDEAs College of Ayurved and Research center 3rd floor shalakyatantra department sector 25 pradhikaran Nigdi Pune MAHARASHTRA 411044 India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Trupti Lawangare  Ayurved Rugnalaya and sterling multispeciality hospital   Sector no 27 Shalakya OPD no 122 Pradhikaran Nigadi Pune
Pune
MAHARASHTRA 		 9145421300

truptilawangare9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Commitee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E539||Vitamin B deficiency, unspecified. Ayurveda Condition: MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Triphaladi Kashaya Gandusha, Reference: Vrundamadhav, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  Patients having minimum 3 classical signs and symptoms- asyadaha, asyaruja, asyavirasya, asyavrana 
 
ExclusionCriteria 
Details  Patients undergone recent oral surgeries, known case of HIV, Syphilis, fungal infections, Known case of carcinoma of oral cavity 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
TO study the efficacy of triphaladi kashaya gandusha given in the dose of 40 ml twice a day for 5 days in pittaj mukhapaka.  5 days treatment with follow-ups on 3rd and 5th day. 
 
Secondary Outcome  
Outcome  TimePoints 
1.TO Assess the efficacy of triphaladi kashaya gandush for managment of pittaj mukhapaka
2.To assess the efficacy of tannic acid,choline salicylate gel local application in managment of pittaj mukhapaka
3.To study the adverse effect if any. 		 5 days treatment with 2 follow up
on 3rd and 5th day 
 
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)   01/12/2024 
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="1" 
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  
 Mukhapaka is pittaja nanatmaj & rakta pradoshaja vikara characterized by vedanayukta vrana in the mukha guha. This study has been undertaken because we come across a number of patients of mukhapaka (stomatitis) in day today practice, It’s incidence is increasing due to poor hygienic conditions, hot & dry climate,poor sanitation. Due to changes in life style, individuals are consuming excessive quantity apathya ahar. i.e. mixed type of food, acidic food, spicy food, cold drinks &additions like chewing tobacco, smoking, drinking alcohol etc. which disturb the internal physiology of body. This causative factors aggrevates the doshas may lead to samprapti of Mukhapaka. Samprapti:- Vitiated Pitta Dosha Causes inflammation & ulceration of oral mucosa, associated with smaller reddish yellow papules develop throughout the mouth this causes severe burning pain, altered taste (Bitter taste), difficulty in mastication deglutition Dosha:-Pitta Sadhyasadhyata:- Sadhya

so in this study treatment modality of gandusha is selected. Among these gandusha, vranaropak drugs are used(Triphala,Patha,Mrudwika,Jaati) Topical countries like India has harsh hot as well cold, humid weathers other are more chances of occurance of various mouth diseases. So it’s need of today to find the specific treatment of mouth diseases, such as mukhapaka. so current topic of research has been taken.

Now a day due to the stressful life, unhygienic conditions, irregular dietary habits and Kapha- Vata

prakopaka Aahara-Vihara tridosha vitiation takes place which results in mukhpaka Hence, there is a

need of better treatment for the management of mukhpaka. All ingredients present in this study

are common and easily available. To limit the use and reduce the side effects of conventional

allopathic treatment Triphaladi kashaya gandusha topic was not used previously in research for
 treatment of pittaj mukhapaka. So, to see the results of drug this topic has selected for research per dose. Assessment will be made as regard to the efficacy of both medicines&some will be compared in this present study
 
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