| CTRI Number |
CTRI/2024/06/068893 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of patoladi gel application in the management of mouth ulcers |
|
Scientific Title of Study
|
An open labeled randomised comparative controlled clinical study to evaluate the efficacy of patoladi gel in the management of mukhapaka with special 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 Manjiri Keskar |
| Designation |
Professor |
| Affiliation |
Parul Institude of Ayurved |
| Address |
Room no 406 Department of Shalakyatantra Parul Institute Of Ayurved Parul University Limda Taluka Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
manjirikeskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hrishika Gupta |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room no 406 Department of Shalakyatantra Parul Institute Of Ayurved Parul University Limda Taluka Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9131404966 |
| Fax |
|
| Email |
skgupta9977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hrishika Gupta |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room no 406 Department of Shalakyatantra Parul Institute Of Ayurved Parul University Limda Taluka Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9131404966 |
| Fax |
|
| Email |
skgupta9977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved,Parul University,Limda,Vadodara,Gujarat 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul University,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 |
| Dr Hrishika Gupta |
Parul Ayurved Hospital |
OPD No 112 Shalakyatantra Parul Ayurved Hospital Parul University PO Limda Taluka Waghodia Vadodara 391760
Vadodara
GUJARAT |
9131404966
skgupta9977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Parul Institute of Ayurved, Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K137||Other and unspecified lesions of oral mucosa. Ayurveda Condition: SARVASARAÂ MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi Gel, Reference: Chakradutta samhita Chapter 50 Shloka 90-91, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 1(ml), Frequency: qid, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tannic Acid and Choline Salicylate gel | Combination of Tannic Acid 5%w/v and Choline Salicylate solution 8% w/v |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients from the age group of 18 – 40 years.
2.Patients having all classical symptoms of Mukhapaka.
3.Male patients having hemoglobin more or equal to 13gm/dl whereas Female patients having hemoglobin more or equal to 11gm/dl.
|
|
| ExclusionCriteria |
| Details |
1.Patients having hyperplasia or neoplasia of buccal cavity
2.Ulcer due to Diabetes, Herpes, Tuberculosis and patients with addiction to tobacco etc.
3.Patient of known case of uncontrolled Hypertension, Diabetes , Thyroid.
4.Immunocompromised patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To cure mukhapaka (stomatitis)(mouth ulcers) |
8th Day,15th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To cure stomatitis |
8th Day, 15th Day |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/08/2024 |
| 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="0"
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
|
In Nidana Sthana, Sushruta has first time described the Mukharogas (diseases affecting the oral cavity) and he has classified the diseases of Mukha, Mukha is a complex structure formed by the combination of Ostha (Lips), Dantamoola (Gums), Danta (Teeth), Jihva (Tongue), Taalu (Palate), Gala (Throat), and Sarvasara (All over Mukha). Stomatitis can be included in one group of the Mukha Rogas, known as “Sarvasara Rogas†The aim of any medical science is for the attainment of level of health which enables every individual to lead a happy life socially and economically. In this regard Ayurveda stands first as it is the science which primarily aims at preservation of positive health and correction of ill health. Oral hygiene plays an important role in every individual. But due to so many vitiating factors like tobacco chewing, smoking, stress, vitamin deficiency, allergic and trauma leading to the Vatadi Dosha and produce 67 Mukha Rogas. The Drugs choosen here have both Shamana and Ropana property, and the drugs which are used for this preparation are economic and commonly available and within the reach of common people In this study the form of drug is changed to “GEL†form which is very convenient to use and palatable It may give fast and good results.
|