| CTRI Number |
CTRI/2024/11/076330 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of steroids and Curcumin, clove oil lozenges in treatment of fibrosis of oral mucosa |
|
Scientific Title of Study
|
Evaluation of efficacy of Curcumin and Clove oil lozenges in comparison to topical triamcinolone acetonide paste in treatment of oral submucous fibrosis: A randomized control 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 |
Richa Srivastava |
| Designation |
post graduate student |
| Affiliation |
DY Patil school of dentistry, Nerul, Navi Mumbai |
| Address |
Post Graduate student, Department of Oral Medicine and Radiology, DY Patil school of Dentistry, Sector 7, NERUL,Navi Mumbai-700706 DY Patil school of Dentistry,Sector 7,Nerul, Navi Mumbai, 400706 Thane MAHARASHTRA 400706 India |
| Phone |
09819271306 |
| Fax |
|
| Email |
richalucknow49@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mandavi Waghmare |
| Designation |
Professor |
| Affiliation |
DY Patil school of dentistry |
| Address |
DY Patil School of dentistry, sector 7, Nerul, Navi Mumbai, 400706 Sector 7,Nerul, Navi Mumbai, 400706 Thane MAHARASHTRA 400703 India |
| Phone |
08108069665 |
| Fax |
|
| Email |
mandavi.waghmare@dypatil.edu |
|
Details of Contact Person Public Query
|
| Name |
Richa Srivastava |
| Designation |
post graduate student |
| Affiliation |
DY Patil school of dentistry, Nerul, Navi Mumbai |
| Address |
Department Of Oral Medicine and radiology, DY Patil school of dentistry, Sector 7, Nerul, Navi Mumbai Sector 7,Nerul, Navi Mumbai, 400706 Thane MAHARASHTRA 400706 India |
| Phone |
09819271306 |
| Fax |
|
| Email |
richalucknow49@gmail.com |
|
|
Source of Monetary or Material Support
|
| GELNOVA LABORATORIES INDIA PVT.LTD
C-125,TTC INDUSTRIAL AREA,MAHAPE, NAVI MUMBAI,MAHARASHTRA,INDIA-400703 |
|
|
Primary Sponsor
|
| Name |
Gelnova Laboratories India OPvt Ltd |
| Address |
GELNOVA LABORATORIES INDIA PVT.LTD,C-125 TTC INDUSTRIAL AREA, MAHAPE, NAVI MUMBAI-400703 |
| 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 MANDAVI WAGHMARE |
DY Patil School of Dentistry |
Department of Oral Medicine And Radiology Thane MAHARASHTRA |
8108069665
mandavi.waghmare@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH AND ETHICAL BOARD D. Y. PATIL DEEMED TO BE UNIVERSITY SCHOOL OF DENTISTRY, NAVI MUMBAI |
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 |
| Intervention |
curcumin and clove oil lozenges |
one lozenge containing Curcuma Longa -100 mg and Clove oil-4 mg
dosage-1 lozenge QID for 60 days
|
| Comparator Agent |
Triamcinolone acetonide oral paste (0.1%) |
To be applied on the affected mucosa twice a day for two months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with OSMF clinically and histopathologically
2.Patients with age group: 18 yr - 60yr
3.Patients with OSMF Stage II and Stage III (More et al classification 2011)
4: Patients who are not treated previously for OSMF.
|
|
| ExclusionCriteria |
| Details |
1. Patients with other mucosal lesions other than OSMF 2.Patients with trismus due to other reasons. 3.Patients who are currently on any treatment for OSMF
4.Patients with co-existing systemic ailments.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Benefit in improvement of mouth opening
2.Improvement of burning sensation |
0, 15 days, 30 days 45 days and 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhancement of overall quality of life of the patient. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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 4 |
|
Date of First Enrollment (India)
|
16/11/2024 |
| 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="0" Months="7" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - By email to contact person
- For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
· Oral submucous fibrosis
(OSMF) is a chronic, inflammatory, and potentially malignant disorder of the
oral cavity, and has been linked to the chewing of areca nut. Oral submucous fibrosis
has a number of characteristic signs and symptoms, including gradual mouth
narrowing, oral mucosal blanching, burning and discomfort while consuming food,
hypomobility of the tongue and soft palate, diminished taste sensibility, and
minor hearing impairment as a result of eustachian tube obstruction. Polyphenols have
antioxidant properties that make them important for both preventing and
treating OSMF. Turmeric, an Indian golden spice, is a polyphenol that has long
been known for its medicinal effects. From ancient times, curcumin, the active
ingredient in turmeric, has been utilized extensively in India as a folk
medicine for many diseases.It is used as an anti-inflammatory, antibacterial, antioxidant, anticancer agent towards treatment of inflammatory, immune mediated and potentially malignant lesions. · Clove (Syzygium aromaticum) is one of the most valuable spices that has been used for centuries as food preservative and for many medicinal purposes plant represents one of the richest sources of phenolic compounds such as eugenol, eugenol acetate and gallic acid and possess great potential for pharmaceutical, cosmetic and food applications. The spice contains a good amount of minerals like magnesium, manganese, potassium, iron, and selenium Antioxidants are compounds which are essential for the treatment of oxidative stress. Treatment with clove oil reduces oxidative stress mediated by reduced glutathione levels. Clove oil and turmeric may provide a powerful combination for management of oxidative stress in OSMF and for improving its signs and symptoms. It may be a potential breakthrough in management of OSMF using indigenous, herbal products. |