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
|
|
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
|
|
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. |