| CTRI Number |
CTRI/2025/07/091750 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment for repeated mouth ulcers with mouth opening difficulty. |
|
Scientific Title of Study
|
Randomized Controlled clinical study of MARCEL poly herbal oral rinse in management of Oral Sub Mucous Fibrosis. |
| Trial Acronym |
MARCEL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nisar Ali Khan |
| Designation |
Professor |
| Affiliation |
Govt Ayurved College and Hospital Nanded |
| Address |
Govt Ayurved College and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9325607099 |
| Fax |
|
| Email |
dr.khan_na@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratibha Kondibarao Waghmare |
| Designation |
Ph D scholar Assistant Professor |
| Affiliation |
Govt Ayurved College and Hospital Nanded |
| Address |
Govt Ayurved College and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9503779408 |
| Fax |
|
| Email |
pratibhawaghmare94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha Kondibarao Waghmare |
| Designation |
Ph D scholar Assistant Professor |
| Affiliation |
Govt Ayurved College and Hospital Nanded |
| Address |
Govt Ayurved College and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9503779408 |
| Fax |
|
| Email |
pratibhawaghmare94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jansuta Pharmaceuticals
N-1201 Iscon Platinum
Bopal circle Bopal Ahmedabad
Gujrat
India
Pin 380058
|
|
|
Primary Sponsor
|
| Name |
Jansuta Pharmaceuticals |
| Address |
N 1201 Iscon platinum
Bopal circle
Bopal
Ahmedabad 380058 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Nisar Ali Khan |
OPD No 24 Shalakya Tantra Department Govt Ayurved College and Hospital |
Vazirabad
Nanded 431601
Nanded
MAHARASHTRA |
9325607099
dr.khan_na@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Govt Ayurved College Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K121||Other forms of stomatitis. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 40 KavalaH | (Procedure Reference: b Shaman or Prasadan KavalaH, Procedure details: 10 drops of MARCEL polyherbal oral rinse in 160 ml of Lukewarm water for gargling for 20 t30 seconds twice or thrice a day)
(1) Medicine Name: MARCEL polyherbal oral rinse, Reference: Contains Mentha spicata Osmium sanctum Eletteria cardmoum Cinnamomum camphora, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: tds, Duration: 60 Days | | 2 | Comparator Arm | Procedure | - | 40 KavalaH | (Procedure Reference: b Shaman or Prasadan KavalaH, Procedure details: 10 drops of Irimedadi oil in 160 ml of lukewarm water for20 to 30 seconds thrice a day)
(1) Medicine Name: Irimedadi oil, Reference: Chapter 61 Mukharogadhikar Bhaishajya Ratnavali, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 10(drops), Frequency: tds, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Oral Sub Mucous fibrosis |
|
| ExclusionCriteria |
| Details |
Extensive fibrosis with severe trismus within inter incisal distance less than 10 mm
Disease is most advanced with premalignant and malignant changes
Generalized fibromatosis
Oral manifestations of scleroderma
Oral lichen plants
Pale Oral mucosa of anaemia mimicking blanching
Chronic debilitating conditions such as TB HIV
Patient not willing to give up addiction habits of Gutka pan masala tobacco etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in inter incisional distance |
Before Treatment 0 day
After treatment 60 th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
15/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Oral Sub Mucous Fibrosis is a common chronic stomatitis leading to trismus It may lead to leukoplakia erythroplakia and malignant changes Satisfactory treatment is not available MARCEL is poly herbal medicine to be used locally as oral rinse in diluted form Drug is FDA approved and clinical trials are already done Control drug Irimedadi oil is an Ayurvedic medicine for local use for chronic stomatitis Multicentric controlled clinical trial is being conducted
|