| CTRI Number |
CTRI/2021/09/036647 [Registered on: 20/09/2021] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Newer herbal treatment modality for management of Lichen Planus |
|
Scientific Title of Study
|
Comparison of Topical Purslane & topical 0.1% triamcinolone acetonide in the management of Oral Lichen Planus - A double blinded clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arul Jothi Murugan |
| Designation |
MDS |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
Department of Oral Medicine and Radiology
SRM dental college Ramapuram
Bharathi salai Ramapuram Chennai
600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9789135432 |
| Fax |
|
| Email |
aruljom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha G |
| Designation |
MDS Ph D |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
HEAD OF THE DEPARTMENT
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
SRM DENTAL COLLEGE
RAMAPURAM,CHENNAI
HEAD OF THE DEPARTMENT
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
SRM DENTAL COLLEGE
RAMAPURAM,CHENNAI
Chennai
TAMIL NADU
600089
India |
| Phone |
9962099944 |
| Fax |
|
| Email |
anug77@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arul Jothi Murugan |
| Designation |
MDS |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
Department of oral Medicine and Radiology
SRM dental college Ramapuram
chenniai
Bharathi salai Ramapuram Chennai
600089
Chennai
TAMIL NADU
600089
India |
| Phone |
9789135432 |
| Fax |
|
| Email |
aruljom@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vels pharmacy college Pallavaram |
|
|
Primary Sponsor
|
| Name |
Dr Arul Jothi Murugan |
| Address |
SRM DENTAL COLLEGE
Bharathi salai Ramapuram Chennai 600089 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mr Murugan |
2/257 Gemini East Teachers Nagar chinniyampalayam Coimbatore 641062 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arul Jothi Murugan |
SRM DENTAL COLLEGE |
Department of Oral Medicine and Radiology, SRM dental college,Bharathi salai Ramapuram Chennai 600089
Chennai
TAMIL NADU |
9789135432
aruljom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review Board of SRM Dental college Ramapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: Oral lichen planus, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: 5%purslane gel extract, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.5(mg), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 5%purslane gel extract, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.5(mg), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: , Reference: NA, Route: , Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: 10% Purslane gel extract, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.5(mg), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 10% Purslane gel extract, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 0.5(mg), Frequency: qid, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: , Reference: NA, Route: , Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 3 | Comparator Arm (Non Ayurveda) | | - | 0.1%triamcinolone acetonide | Apply 0.5 mg of gel over the lesion 3-4 times a day.Rinse it off after 20-30 minutes. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to participate in the study.
Patients with symptomatic (burning sensation or pain) reticular type oral lichen planus and who had not under gone any previous treatment for the same in the last six months.
Clinically and histopathologically confirmed Oral lichen Planus.
Patients with other systemic diseases ( Diaebtes & hypertension) & those not under any long term glucocorticosteroid therapy.
|
|
| ExclusionCriteria |
| Details |
Histopathologically proven lichenoid reaction.
Patients with other white lesions like leukoplakia, systemic lupus erythematosus(SLE) along with oral lichen planus.
Patients with other systemic diseases & those on long term glucocorticosteroid therapy.
Patients having extra oral manifestations of oral lichen planus during the duration of treatment.
Pregnancy, lactation.
History of allergic reactions to herbal preparations.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Alllieviatiom of burning sensation |
Baseline, 2nd week,1st,2nd & 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief of symptoms |
3 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2021 |
| Date of Study Completion (India) |
01/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To assess the efficacy of topical purslane in two concentrations (5% &10%) in treating symptomatic oral lichen planus. To assess the efficacy of topical 0.1% triamcinolone acetonide gel in symptomatic oral lichen planus. To compare the level of clinical improvement on oral lichen planus patients using purslane and 0.1% triamcinolone acetonide gel. No statistically significant difference between the compared groups pertaining to the study variables (burning sensation, pain, lesion score, symptomatic response of burning sensation, symptomatic response of pain, clinical response) at all the five time periods (baseline, 2 weeks, 1 month, 2 months and 3 months). Intragroup comparison revealed that there was a statistically significant difference between the five time periods (baseline, 2 weeks, 1 month, 2 months and 3 months) for the study variables (burning sensation, pain, lesion score) for all the three groups (p=0.001). No burning sensation, pain as well as lesion was observed for all the three groups at the end of three months. This study implies Topical Purslane gel can be used as an safer alternative treatment modality for alleviating the symptoms of Oral Lichen planus with lesser side effects. |