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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  By email to contact person

  6. 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.

  7. 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.

 

 
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