| CTRI Number |
CTRI/2025/02/081140 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to see the effect of some ayurvedic formulation in the treatment of Mukhapaka with reference to stomatitis. |
|
Scientific Title of Study
|
A randomized controlled trial to study the efficacy of Patoladi Kashay Ghanvati Kavala and Chlorhexidine0.2% oral rinse mouth wash in Mukhapaka with reference to 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 Pratiksha Suresh Admane |
| Designation |
MS Scholar Shalakyatantra (Ayurveda) |
| Affiliation |
M.A.M.s Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD NO.8 Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road Hadapsar Pune MAHARASHTRA 411028 INDIA Pune MAHARASHTRA 411028 India
Pune
MAHARASHTRA
411028
India |
| Phone |
7972718149 |
| Fax |
|
| Email |
pratikshasadmane31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumedha Y Kotangale |
| Designation |
Assistant Professor |
| Affiliation |
M. A. M. s Sumatibhai Shah Ayurved Mahavidyalay, Hadapsar, Pune |
| Address |
OPD NO 8 Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road Hadapsar, Pune. MAHARASHTRA 411028 INDIA
Pune
MAHARASHTRA
411028
India |
| Phone |
8275298480 |
| Fax |
|
| Email |
sumedhayk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumedha Y Kotangale |
| Designation |
Assistant Professor |
| Affiliation |
M. A. M. s Sumatibhai Shah Ayurved Mahavidyalay, Hadapsar, Pune |
| Address |
OPD NO 8 Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road Hadapsar, Pune. MAHARASHTRA 411028 INDIA
Pune
MAHARASHTRA
411028
India |
| Phone |
8275298480 |
| Fax |
|
| Email |
sumedhayk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra. Sane Guruji Arogya Kendra Malwadi, Hadpsar, Pune MAHARASHTRA 411028 INDIA |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
OPD NO.8 Department of Shalakyatantra Sane Guruji Arogya Kendra, Malwadi Road Hadapsar, Pune MAHARASHTRA 411028
INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pratiksha Suresh Admane |
Sane Guruji Arogya Kendra Malwadi Road Hadapsar Pune |
OPD NO.8 Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road Hadapsar, Pune MAHARASHTRA 411028 INDIA
Pune
MAHARASHTRA |
7972718149
pratikshasadmane31@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 |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: SARVASARA MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi kashay Ghanavati , Reference: Ashtang Sangraha, Route: Topical, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu with lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | CHLORHEXIDINE0.2% SOLUTION | Chlorhexidine gluconate0.2%
Route of administration: Topical
Frequency:BID
Total duration:7days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from symptoms of Mukhapaka or stomatitis like Vranotpatti (ulceration), Rakt Varna (redness), Shoola (pain), Daha (burning sensation) any two or more than two of them.
2. Patients indicated for Kavala. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women and children.
2. History of congenital disorder of oral cavity.
3. Chronic or Carcinogenic ulcer in the oral cavity.
4. Patient contra-indicated for kavala karma.
5. Patient who is not ready for drug trial and giving follow up. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms of Mukhapaka like Vranotpatti (ulceration), Rakt Varna (redness), Shoola (pain), Daha (burning sensation) decreased and relief from stomatitis.
|
follow up on 4th, 7th day, symptoms will be noted before and after the treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
decrease in severity, intensity,duration ofsymptoms
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="15" |
|
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
|
Mukhpaka is made of two words one is Mukha means Mouth and second is Paka meance inflammation or ulceration. i.e. inflammation n ulceration at the mucous membrane of mouth and lips, tongue, cheek, gums, roof and floor of the mouth.Mouth is the gateway of whole body. This determines the importance of oral health in overall health. The global burden of diseases study 2017, reveal the nearly 3.5 billion people are affected by oral diseases including oral cancers. this shows the existing oral hygiene not much effective up to desired level. In Ayurveda Kavala and Gandusha are the procedures described in Dincharya ie. daily regimen and useful in prevention of the diseases of oral cavity.The Present study is conducted to assess the efficacy of Patolodi Kashaya Ghanvati Kavala in Mukhapaka, while this yoga possess. Sheeta Virya (cold potency) along with kashaya Rasa (astringent taste), tikthata rasa (bitter taste) and madhura rasa (sweet taste) which facilitates Ropana (healing) and Shamana (palliative) action simultaneously. |