| CTRI Number |
CTRI/2025/02/080269 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial in Oral Sub Mucous Fibrosis patients |
|
Scientific Title of Study
|
A randomized, double-blind, active controlled, parallel-group, clinical study to evaluate the efficacy and safety of poly herb gel in treatment of clinically diagnosed stage I and Stage II Oral Sub Mucous Fibrosis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Natureorama/OSMF/ 2024 Version 1.0 dated 25th March 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Roopashri |
| Designation |
Principal investigator and Professor and HOD Department of Oral Medicine and Radiology |
| Affiliation |
M R Ambedkar medical college and Hospital |
| Address |
Second floor Room number 3 Department of Oral Medicine and Radiology Cline road Cooke Town
Bangalore -50005 Karnataka India
Bangalore
KARNATAKA
50005
India |
| Phone |
8951863439 |
| Fax |
|
| Email |
roopadr@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sri H Srinivas |
| Designation |
Director |
| Affiliation |
Natureorama Private Limited |
| Address |
#130/212 And 15/6, Hallimala Near Konkanidoddi Sri Rama Temple, Ramanagar Bangalore Rural Karnataka India
Bangalore
KARNATAKA
562159
India |
| Phone |
9448080317 |
| Fax |
|
| Email |
sreenivas.drugs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sri H Srinivas |
| Designation |
Director |
| Affiliation |
Natureorama Private Limited |
| Address |
#130/212 And 15/6, Hallimala Near Konkanidoddi Sri Rama Temple, Ramanagar Bangalore Rural Karnataka India
Bangalore
KARNATAKA
562159
India |
| Phone |
9448080317 |
| Fax |
|
| Email |
sreenivas.drugs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Group Pharmaceuticals Ltd 2nd Block, 521/A, 2nd Main Rd, Milk Colony, 2nd Stage, Rajajinagar, Bengaluru, Karnataka 560055 |
| Natureorama Private Limited #130/212 And 15/6, Hallimala Near Konkanidoddi Sri Rama Temple, Ramanagar Bangalore Rural 562159 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Group Pharmaceuticals Ltd |
| Address |
2nd Block, 521/A, 2nd Main Rd, Milk Colony, 2nd Stage, Rajajinagar, Bengaluru, Karnataka 560055 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Natureorama Private Limited |
#130/212 And 15/6, Hallimala Near Konkanidoddi Sri Rama Temple, Ramanagar Bangalore Rural 562159 Karnataka India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrG Roopashri |
M R Ambedkar Dental college and Hospital |
Second floor Room number 3 Department of Oral Medicine and Radiology Cline road Cooke Town
Bangalore -50005 Karnataka India
Bangalore
KARNATAKA |
8951863439
roopadr@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Plain Water along with SOC |
Topical application of herbal gel 2 gm 2 to 3 times daily to be applied on affected area of the mouth for 12 weeks. |
| Intervention |
Poly herb gel (SQUA Care Gel) |
Topical application of herbal gel 2 gm 2 to 3 times daily to be applied on affected area of the mouth for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient who are clinically diagnosed with OSMF aged between 18 to 65 years
2. OSMF with grade I, and II will be included without any underlying comorbidities
3. Patients who are ready to quit the habit of betel quid/ areca nut/
gutkha chewing and are willing for regular follow-ups.
4. Must be willing and able to give informed consent and comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
1. Debilitating diseases such as carcinoma.
2. Patients contraindicated for steroids.
3. Patients with other mucosal disorders with clinical features same as OSF (such as: trismus due to Temporomandibular Joint Dysfunction, pericoronitis, space infection, history of surgery or trauma, systemic sclerosis, amyloidosis, iron deficiency anemia, radiation therapy).
4. Patients who were under treatment or have had already undergone treatment for OSF.
5. The patients with history of hypersensitivity to hyaluronidase.
6. Patients with history of hypersensitivity to herbal drugs
7. Patients with OSMF of Grade III and IV
8. Patients already on systemic steroids
9. Pregnant and lactating mothers.
10. Disease is most advanced with premalignant and malignant changes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The mean improvement in interincisal mouth opening
2.The mean improvement in cheek flexibility
3.The mean improvement in tongue protrusion
|
Day 0 Day 30 Day 60 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain VAS
2. OSMF questionnaire
3. Pain/Burning sensation
4. Interincisal
5. mouth opening
6. Tongue protrusion
7. Difficulty in swallowing
8. Ulcerations
9. Swelling
10. SF-36 Questionnaire
|
Day 0 Day 30 Day 60 and Day 90 |
Salivary Biomarkers (SImmunoglobulins)
Haematology Biochemistry
|
Day 0 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
There is multi drug concept in treating OSMF and use
of steroids will have long term disadvantage. Disadvantage of intralesional
injections can form more fibrous bands, mucosal
atrophy, difficulty to deposit sufficient quantities into gingival lesions, injection are painful and intrusive. Herbal medicine has been used for
thousands of years to treat a variety of health issues. It’s generally
gentler on the body and has fewer side effects than prescription drugs, and it
can also be more affordable.
The World Health Organization guidelines
define herbal medicines as finished,
labeled medicinal products containing an active ingredient, i.e., obtained from the aerial or underground parts
of botanicals or other plant materials or
their combination.4
Hence using poly herb has
medicinal or rasaya properties provide a synergestic effect in the treatment.
It is also safer and more potent in long term. Starting a poly herbal gel
improves prognosis of the disease |