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CTRI Number  CTRI/2018/01/011499 [Registered on: 23/01/2018] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of mouth ulcer  
Scientific Title of Study   A clinical study on the management of mukhapaka with special reference to stomatitis with patoladi kwath gandusha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meghana B Dangar 
Designation  P.G. scholar 
Affiliation  Parul Institute of Ayurveda 
Address  Department of Shalakya Tantra , Parul Institute of Ayurveda,Parul university, waghodia-limda

Vadodara
GUJARAT
391760
India 
Phone  7567772024  
Fax    
Email  dr.megd03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajeev G Dole 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  Department of Shalakya Tantra, Parul Institute of Ayurveda,Parul university, waghodia-limda

Vadodara
GUJARAT
391760
India 
Phone  9822563595  
Fax    
Email  to_rgd@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Meghana B Dangar 
Designation  P.G. Scholar 
Affiliation  Parul Institute of Ayurved 
Address  Department of Shalakya Tantra , Parul Institute of Ayurved,Parul university, waghodia-limda

Vadodara
GUJARAT
391760
India 
Phone  7567772024  
Fax    
Email  dr.megd03@gmail.com  
 
Source of Monetary or Material Support  
Parul institute of Ayurved, Parul university , Waghodia-Limda , Vadodara 391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved and Hospital 
Address  Parul university , Waghodia-Limda , Vadodara, Gujarat 391760 
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 
Meghana B Dangar  Parul Ayurved Hospital  Opd no 109 ,Department of Shalakya Tanta, Parul Institute of Ayurveda,Parul university, waghodia-limda
Vadodara
GUJARAT 
7567772024

dr.megd03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Mouth ulcers,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Patoladi kwath  Purchase of raw materials of all the ingredients and preparation of patoladi kwath will be done in collaboration with GMP certified, Parul Ayurvedic Pharmacy, Vadodara 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1- Patients complaining acute and recurrent Mukhapaka
2- Ulcer are 1 to 5 in numbers and less than 10mm in size 
 
ExclusionCriteria 
Details  1- Traumatic- Medical, Chemical, Thermal, Factitious Injury, Radiation, Eosinophilic ulcer
2- Patients who are contraindicated for gandusha
3- Patient having chronic or carcinoma ulcers in oral cavity.
4- Mukhapaka due to any other disorders e.g. Syphilis, AIDS, Dengue, Haemorrhagic Fever etc.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Subjective parameters:
Relief in
1.Ruja
2.Daha
3.Rakta varnata of vrana 
Subjective parameters:
Relief in
1.Ruja
2.Daha
3.Rakta varnata of vrana 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of vrana
2. Frequency of recurrence
Suitable gradation index will be fixed for the above parameters 
7 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   28/02/2018 
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   Not yet done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
 Hypothesis -Patoladi kwath gandusha is effective in treating the Mukhapaka
The estimated prevalence of oral ulcers worldwide 25%. Mukhapak is a common disease of the oral cavity. It found affects in daily routine practice. It is found more in pitta pradhan dosha dusti, pitta pradhan prakruti and pittaj kala. It is more found in India because people are more prone to have pitta prakopak ahar like spicy oily food, tobacco chewing, smoking, alcohol consumption and also pitta prakopak vihar like late night sleeping, improper timing of meals. Due to this nidan ushna guna of pitta are increasing and generate ulceration in mouth because in our science already mentioned that mukha is mirror of koshtha. Thats why digestion is major role for stomatitis. The exact etiology of stomatitis is uncertain but precipitating factor are stress, trauma, indigestion, vitamin deficiency, food allergy. Stomatitis is an inflammation of the mucous lining of the mouth, which may involve the cheeks, gums, tongue, lips and roof or floor of the mouth. The inflammation may be caused by conditions in the mouth itself, such as poor hygiene, from burns from hot food or drinks, or by conditions that affect the entire body, such as medications, allergic reactions or infections. 
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