| CTRI Number |
CTRI/2023/03/050422 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Treatment for Oral Submucosal Fibrosis |
|
Scientific Title of Study
|
Clinical comparative study to evaluate the
effect of polyherbal muco adhesive patch and
pratisarana with Ashwagandadi lehya in the
management of Oral Sub Mucosal Fibrosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veerayya R Hiremath |
| Designation |
Professor and HOD |
| Affiliation |
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital |
| Address |
Department of shalakya tantra
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital , gavimutt campus , koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9448544376 |
| Fax |
|
| Email |
drvrh.aug15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veerayya R Hiremath |
| Designation |
Professor and HOD |
| Affiliation |
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital |
| Address |
Department of shalakya tantra
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital , gavimutt campus , koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9448544376 |
| Fax |
|
| Email |
drvrh.aug15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veerayya R Hiremath |
| Designation |
Professor and HOD |
| Affiliation |
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital |
| Address |
Department of shalakya tantra
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital , gavimutt campus , koppal
Koppal
KARNATAKA
583231
India |
| Phone |
9448544376 |
| Fax |
|
| Email |
drvrh.aug15@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF RESEARCH AND DEVELOPMENT
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES |
|
|
Primary Sponsor
|
| Name |
Department of Shalakya tantra |
| Address |
Department of shalakya tantra
Shree Jagadguru Gavisiddeshwara ayurvedic medical college and hospital , gavimutt campus , koppal |
| 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 Veerayya R Hiremath |
SHREE JAGADGURU GAVISIDDESHWARA AYURVEDIC MEDICAL COLLEGE and hospital |
Room no 04 ,Department of Shalakya tantra
Koppal
KARNATAKA |
9448544376
drvrh.aug15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional clinical Ethics committee |
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: SANNIPATAJA MUKHAPAKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: poly herbal churna, Reference: NA, Route: Oral, Dosage Form: Lepa Churna, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: poly herbal muco adhesive patch, Reference: NA, Route: Oral, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients between the age of 20 years and 60 years
2) Patients irrespective of sex, occupation, religion and economic
status.
3) Patients presenting with signs and symptoms of oral sub
mucous fibrosis.
4) Patients voluntarily willing to quit the habit. |
|
| ExclusionCriteria |
| Details |
1) Age less than 20 years and above 60 years.
2)Patients suffering from systemic disorders like Diabetes mellitus
etc
3) Disease condition with malignant changes in the oral cavity.
4) Patients not willing to give up habit of chewing gutka, tobacco,
pan masala. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in sign and symptoms of OSMF like wide opening of the mouth and reduction in the patch in the oral mucosa |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in all symptoms |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
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 (OSMF) is a chronic debilitating disease of the oral cavity characterized by inflammation and progressive fibrosis of the lamina propria and sub mucosa that results in marked rigidity and eventually inability to open the mouth.1 It manifests as blanching and stiffness of the oral mucosa, trismus, burning sensation in the mouth, intolerance to eating hot and spicy foods, repeated vesicular eruption and ulceration of the buccal mucosa, palate and pillars, loss of gustatory sensation. Habit of betel nut and tobacco chewing, excessive consumption of chilies and spices, genetic susceptibility, immune mediated process, smoking, drinking alcohol coupled with dietary deficiencies are thought to be the causative factors of the OSMF2 . Probably involved pathogenesis is stimulation of fibroblast production, increased collagen synthesis due to areca nut alkaloids mainly are coline along with stabilization of collagen structure by catechin and tannin contents of areca nut3 . 3 On analyzing the disease condition with Ayurvedic approach, it seems to be nearer to Vata-Pitta dominant chronic Sarvasara Mukharoga4 and needs to be treated at local as well as systemic level. Hence the herbal drugs like Yashtimadhu, Mandukaparni, Haridra , Kumari , Madhu have been selected due to their antiinflammatory, antioxidant, and anticancer properties and it suppresses the connective tissue growth and decreases cellular fibrogenic activity5 . The lesions are usually treated using topically by pratisarana, kavala and gandusha but current drug delivery systems seems inadequate and new ways of delivering these therapeutic agents directly to lesions are required. Controlled delivery of drugs to the oral mucosa is challenging because of moist mucosal surfaces, salivary flow and abrasive forces within the oral cavity. To overcome these obstacles it is planned to prepare polyherbal muco adhesive patch6 and compare its efficacy with Pratisarana in the management of Oral Sub Mucosal Fibrosis. Ashwagandadi lehya7 will be administered to both groups as rasayana |