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CTRI Number  CTRI/2018/10/015878 [Registered on: 03/10/2018] Trial Registered Prospectively
Last Modified On: 27/09/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate the efficacy of Svarnsaathi (a proprietary formulation enriched with curcumin) in the treatment of Oral Sub-Mucous Fibrosis  
Scientific Title of Study   A Randomized Multicentric, Placebo-controlled, Parallel, Double-blinded clinical trial to evaluate the efficacy of Svarnsaathi (a proprietary formulation enriched with curcumin) in the treatment of Oral Sub-Mucous Fibrosis  
Trial Acronym  OSMF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shamala 
Designation  Consultant 
Affiliation  Family Dental Care 
Address  Family Dental Care K.V.N Complex, Old Bus Stand NMB,Devanahalli

Bangalore Rural
KARNATAKA
562110
India 
Phone  998663696  
Fax    
Email  shamala_yadavmds@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Dayananda 
Designation  General Manager 
Affiliation  BioAgile Therapeutics Pvt Ltd 
Address  2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore
2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
Bangalore
KARNATAKA
560094
India 
Phone  9980107723  
Fax    
Email  pm@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya C 
Designation  Director 
Affiliation  BioAgile Therapeutics Pvt Ltd 
Address  2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Sponsored trial 
 
Primary Sponsor  
Name  BigBrother Nutra Care Pvt Ltd  
Address  N.S.Phadke Marg Andheri (E) Mumbai- Maharashtra INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shamala  Family Dental Care Family Health Care   K V N Complex Old Bus Stand Near Mayura Bakery, Devanahalli 562110
Bangalore Rural
KARNATAKA 		 9986636961

shamala_yadavmds@yahoo.com 
Dr Suman G  Raja Lakshmi Hospital  21/1 Lakshmipura main road opp lakshmipura lake vidhyaranyapura post
Bangalore
KARNATAKA 		 9986046906

drsumanraj6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M265||Dentofacial functional abnormalities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Starch powder, identical as investigational drug 4g sachets. to be taken orally once in morning daily for 3months 
Intervention  Svarnsaathi, 4g sachets  The product is a natural product and intended for the mild to moderate oral sub-mucous fibrosis symptoms relief. To be taken orally once in morning daily for 3months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Males and females aged ≥18
2. Participants (or legally acceptable representative) who are voluntarily willing to participate in the study and sign/thumb-stamped the informed consent document
3. Willingness to use the assigned products according to instructions and other study steps, availability for appointments, and likelihood of completing the clinical trial.
4. No concurrent participation in any other oral care clinical study.
Oral Inclusion Criteria
1a. Moderate oral submucous fibrosis (defined interincisal distance equal to or greater than 20mm but less than 35mm AND at least one of the following clinical features):
a) fibrous banding (ie stiff/leathery mucosa)
b) blanching of mucosa
c) burning symptoms (>20mm on items 1 or 2 on oral symptoms VAS)
1b. Mild oral submucous fibrosis (defined as interincisal distance equal to or greater than 35mm but less than 45mm AND at least one of the following clinical features)
a) fibrous banding (ie stiff/leathery mucosa) b) blanching of mucosa
c) burning symptoms (>20mm on items 1 or 2 on oral symptoms VAS)  
 
ExclusionCriteria 
Details  1. Current or prior history of oral cancer.
2. Radiation therapy to the head or neck region.
3. No recent treatment for OSMF, particularly steroids (within 3 months).
4. Medical conditions which in the opinion of the investigator may compromise the subject’s health or the outcome of the study. (eg ischemic heart disease (angina, recent MI, or connective tissue diseases).
5. Observable oral conditions (eg odontogenic infections) contributing to trismus which in the opinion of the investigator may compromise the subject’s health or the outcome of the study.
6. Women who are, or will become, pregnant or lactating during the course of the study.
7. Participants who are not willing to give their consent to participate in the trial Inability to obtain informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The measure of mouth opening will be assessed by Vernier calipers measuring inter incisal distance  week0 week4 week 8 week12 
 
Secondary Outcome  
Outcome  TimePoints 
The measure of oral symptoms particularly oral burning will be assessed by visual analogue scale  week0 week4 week 8 week12 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/10/2018 
Date of Study Completion (India) 19/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Oral submucous fibrosis (OSMF) is a precancerous condition that is associated with significant functional morbidity and an increased risk for malignancy. It initially affects the lamina propria of the oral mucosa and as the disease progresses it involves the submucosa and the deeper tissues including muscles of the oral cavity with resulting loss of fibro-elasticity. The clinical manifestations include blanching and stiffening of the oral mucosa leading to limitation in oral opening. The presence of fibrous bands in lips, cheeks and soft palate is a hallmark of the disease. The disease extends over time to include the oropharynx and the upper third of the oesophagus. The etiology of the disease over the intervening years was thought to be multifactorial and several agents have been implicated, including the consumption of large amounts of chillies, chronic iron, vitamin B-complex deficiency, anaemia, nutritional deficiencies, genetic predisposition, and auto-immune disease, in addition to the mentioned etiologies, the other local irritants like tobacco (smoking and non smoking). The custom among Indians of chewing "pan" (betel leaf with tobacco powder and other ingredients) and also habit of areca nut /Gutkha chewing has led to the assumption that these habits are also the cause of submucous fibrosis. Several pathogenic mechanisms have been proposed, all based on the constituents of areca nut and genetic susceptibility to the disease. Reports on the frequency of encountering OSMF suggests that the disease has rapidly increased in India from an estimated 250,000 in 1980 to 2 million cases in 1993. The reasons for this rapid increase of the disease is believed to be attributed to the commercial marketing strategies of the pan masala industry which produces and markets freeze-dried preparations of areca nut, and the growth in uptake of this habit by young people (Gupta, 1999). Various classification systems for OSMF based on clinical (Warnakulasuriya, 1987), (Maher et al., 1996) and histopathological criteria (Pindborg & Sirsat, 1966) exist. There are no established markers to identify who may be predisposed to the disease nor to identify the risk of malignancy in affected individuals.  
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