| CTRI Number |
CTRI/2024/08/072568 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
15/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Malabar spinach gel for reducing mouth discomfort and white patches in the mouth |
|
Scientific Title of Study
|
Comparative efficacy of topical Basella alba gel and Clobetasol propionate gel for the management of Oral Lichen Planus- a double blinded randomized controlled trial |
| 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 Pavithra G |
| Designation |
Post graduate student |
| Affiliation |
KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology
KLE Vishwanath Katti Institute of Dental Sciences,
KLE Academy Of Higher Education And Research,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9677533351 |
| Fax |
|
| Email |
paviviji75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavithra G |
| Designation |
Post graduate student |
| Affiliation |
KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology
KLE Vishwanath Katti Institute of Dental Sciences,
KLE Academy Of Higher Education And Research,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9677533351 |
| Fax |
|
| Email |
paviviji75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zameera Naik |
| Designation |
Professor |
| Affiliation |
KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral Medicine and Radiology
KLE Vishwanath Katti Institute of Dental Sciences,
KLE Academy Of Higher Education And Research,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9448854710 |
| Fax |
|
| Email |
drznaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Vishwanath Katti Institute of Dental Sciences, BELAGAVI KARNATAKA 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Pavithra G |
| Address |
Department of Oral Medicine and Radiology
KLE Vishwanath Katti Institute of Dental Sciences,
KLE Academy Of Higher Education And Research,
JNMC Campus, Nehru Nagar |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Pavithra G |
KLE VK Institute of dental sciences |
Department of Oral Medicine and Radiology, Department Number 1, Ground floor,
KLE Vishwanath Katti Institute of Dental Sciences,
KLE Academy Of Higher Education And Research,
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA |
9677533351
paviviji75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Basella alba gel |
Topical application of the gel on the oral mucosa thrice daily after breakfast, lunch and dinner for 60 days will be advised. Sufficient quantity of the gel will be used based on the size of the lesion (approximately 1g per application) |
| Comparator Agent |
Clobetasol Propionate gel |
Commercially available product will be used. Topical route of application on the oral mucosa thrice daily after breakfast, lunch and dinner for 60 days will be advised. Sufficient quantity of the gel will be used based on the size of the lesion (approximately 1g). If there is complete regression in the lesion size and symptom(burning sensation) in less than 60 days, the dosage and frequency will be advised to stop as it is a steroid drug. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients clinically diagnosed with Oral lichen planus (all variants according to Andreason ) irrespective of mucocutaneous involvement.
2. Patients above 18 years of age and of either gender.
3. Patients who are willing to participate in this study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with potentially malignant disorders other than Oral lichen planus.
2. Patients with systemic diseases.
3. Pregnant and lactating females.
4. Patients who have already undergone treatment for Oral lichen planus (within the past 3 months).
5. Patients who are allergic to Basella alba gel after oral mucosa patch test.
6. Patients who refuse follow-up.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the intensity of burning sensation and reduction in the size of the lesion |
15 days, 30 days, 45 days, 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether Basella alba gel can or cannot be used as an alternative treatment modality for the management of Oral Lichen planus and whether it has comparable effects of Clobetasol propionate will be known |
15 days, 30 days, 45 days, 60 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
26/08/2024 |
| 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="2"
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
|
NULL HYPOTHESIS: There will be no change in the intensity of burning sensation and size of the lesion on application of Basella alba gel in comparison to Clobetasol propionate gel in Oral Lichen planus patients.
ALTERNATIVE HYPOTHESIS: There will be a change in the intensity of burning sensation and size of the lesion on application of Basella alba gel in comparison to Clobetasol propionate gel in Oral Lichen planus patients.
Clinical evaluation of the efficacy of Basella alba gel and Clobetasol propionate gel:
Clinically diagnosed cases of Oral lichen planus (according to Andreason) with bilateral white striations along with burning sensation will be included in this study. The clinical evaluation of burning sensation will be done using Numeric pain rating scale and the size of the lesion will be measured by a vernier caliper(according to RECIST criteria) by the first investigator. The second investigator will be allocating the patients by randomized concealed chit method (stratified method of allocation will be followed for categorizing Oral lichen planus cases into moderate and severe, using scoring of Malhotra et al,2008) as Group I and Group II ( 32 participants under each group). The application of the gel will be demonstrated to the patients by the second investigator and checked for adverse reaction after a time period of half an hour. The patients will then be advised for topical application of Basella alba gel and Clobetasol propionate gel respectively with sterile cotton buds thrice a day after breakfast, lunch and dinner. Both the patient and the first investigator will be blinded of the type of intervention. Patients will be recalled after 15, 30, 45, 60 days for reevaluation of burning sensation with Numeric pain rating scale and size of the lesion( RECIST criteria) by the first investigator. The application of gel will be advised until the healing of lesion.
RECIST CRITERIA: The RECIST system is a simplified tumor measurement by using only the longest uni-dimensional measurement of a lesion, and for multiple lesions, using the sum of the longest diameters. |