| CTRI Number |
CTRI/2025/08/092375 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy
of Kankol Hima As a Gandusha upakrama in
Mukhapaka |
|
Scientific Title of Study
|
Randomised control clinical trial to study the efficacy of Kankol hima as a Gandusha upakrama in Mukhaswasthya with special refrence to mukhapaka 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 Onkar Sunil Pawar |
| Designation |
Pg scholar |
| Affiliation |
LRP ayurved college Islampur Sangli |
| Address |
Swasthavritta Opd Loknete Rajarambapu Patil Ayurvedic Medical
College Hospital PG Institute and Research Center Islampur 415409
Dist Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9004363613 |
| Fax |
|
| Email |
onkarspawar19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Nakil |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurved college Islampur Sangli |
| Address |
Swasthavritta Opd Loknete Rajarambapu Patil Ayurvedic Medical
College Hospital PG Institute and Research Center Islampur 415409
Dist Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9850920891 |
| Fax |
|
| Email |
shwetanakil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Nakil |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurved college Islampur Sangli |
| Address |
Swasthavritta Opd Loknete Rajarambapu Patil Ayurvedic Medical
College Hospital PG Institute and Research Center Islampur 415409
Dist Sangli MAHARASHTRA 415409
MAHARASHTRA
415409
India |
| Phone |
9850920891 |
| Fax |
|
| Email |
Shwetanakil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital Post Gradute Institute and Research Center Islampur 415409 Dist Sangli |
|
|
Primary Sponsor
|
| Name |
LRP Ayurved college Islampur Sangli |
| Address |
Swasthavritta OpdLoknete Rajarambapu Patil Ayurvedic Medical College Hospital Post Gradute Institute and Research Center Islampur 415409 Dist Sangli |
| 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 Shweta Nakil |
LRP Ayurved college and hospital Islampur Sangli |
Swasthavritta Opd Loknete Rajarambapu Patil Ayurvedic Medical
College Hospital PG Institute and Research Center Islampur 415409
Dist Sangli MAHARASHTRA 415409
Sangli
MAHARASHTRA |
9850920891
shwetanakil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurved college Islampur sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KANKOL , Reference: Siddha prayog latika, Route: Oral, Dosage Form: Sheeta/ Hima, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala kwatha, Reference: Bhaishajya ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from clinical sign & symptoms of stomatitis
like ulcer in mouth, redness, pain etc.
2. Patients of age group 18-50 years of both genders will be
selected.
3. Patients will be selected irrespective of gender, education
status, Socio-economic status.
4. Only those patient will be selected who are willing to give
written consent. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from serious systemic illness which may
interfere with course of treatment.
2.Patients having non-healing chronic ulcers, malignancy and
syphilis etc.
3.Patient suffering from allergic stomatitis.
4.Patient having chronic or carcinogenic ulcers in oral cavity.
Mukhapaka due to any other systemic disorder e.g. Syphilis,
AIDS, etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study Kankol Hima as a Gandusha Upakrama in Mukhaswasthya
with refrence to Mukhapaka [Stomatitis]. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study literature regarding Gandusha Upakrama in detail.
2. To study Kankol Hima in detail.
3. To study literature regarding Mukhapaka [Stomatitis] |
7 days |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/08/2025 |
| 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="0"
Months="3"
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
|
KANKOL HIMA. Oral ulceration is a common complaint of patients attending
outpatient department. As per Ayurveda Mukha Rogas is Pittaja
Nanatmaja and Rakta Pradoshaja Vikara and around 25percentage of
population is suffering with this problem.Many treatment modalities like antibiotics, anti-inflammatory,
Anaesthetics drugs, supplements like vitamins etc. are tried in
modern science, which are either limited or unsatisfactory.
Acharya’s mentioned Dinacharya i.e. daily regimen many years
ago, for the maintenance of proper health which helps to keep
disease away, also boosts immunity or immune power of the person.
In this study, Kankol Hima Gandusha will be used as Gandusha
Upakrama in Mukhaswasthya w.s.r. to Mukhapaka. Kankol is laghu,
Tikshna and having properties like Ruchiprada, Deepana, Pachana,
Mukhavaishadyakara.
|