| CTRI Number |
CTRI/2018/02/011939 [Registered on: 16/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SNEC30 (CURCUMA LONGA) CAPSULES AND SNEC ORAL GEL TOPICAL APPLICATION IN THE TREATMENT OF ORAL SUBMUCOSAL FIBROSIS |
|
Scientific Title of Study
|
A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SNEC30 (CURCUMA LONGA) IN THE TREATMENT OF ORAL SUBMUCOSAL 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 Narsingh Verma |
| Designation |
Professor |
| Affiliation |
Physiology |
| Address |
Department of Physiology
KGMU Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839064560 |
| Fax |
|
| Email |
narsinghverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narsingh Verma |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Physiology
KGMU Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839064560 |
| Fax |
|
| Email |
narsinghverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navneet Kumar Gupta |
| Designation |
B.A.M.S (Ayurvedacharya) |
| Affiliation |
Panchkarma |
| Address |
Geeta Ayurveda
Basement Govind Complex Near Sankata Mandir Bangla Bazar
Lucknow UP
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9415548480 |
| Fax |
|
| Email |
navneetgupta1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arbro Pharmaceuticals Pvt Ltd is proving the study medication and test cost to the investigator. |
|
|
Primary Sponsor
|
| Name |
Arbro Pharmaceuticals Pvt Ltd |
| Address |
6/14, Kirti nagar Ind. Area, Kirti nagar, New Delhi |
| 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 Narsingh Verma |
King George Medical University |
King George Medical University Lucknow
Lucknow
UTTAR PRADESH |
9839064560
narsinghverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University Institutional Ethics Committee Lucknow UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ORAL SUBMUCOSAL FIBROSIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional treatment |
conventional treatment as per center practice |
| Intervention |
SNEC30 (Curcumin Therapy) |
Each 900 mg capsule contains:-
SNEC30 (Curcuma Longa) Eq. to Curcuminoids …. 30 mg
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient or his legally accepted representative is willing to give informed consent.
2. Patient is in the age range of 18-65 yrs.
3. Patient clinically diagnosed with OSF (diagnosed on the basis of reduction in interincisal distance on maximum mouth opening and palpable fibrous bands involving oral mucosa).
4. Patient is willing to discontinue the use of tobacco in any form or areca 1-month prior to the commencement of the treatment.
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in burning sensation.
Improvement in mouth opening.
|
reduction in burning sensation and mouth opening will be checked at enrollment day , day 28, day 56 and day 84.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability of the drug will be evaluated on the basis of occurrence / non-occurrence, type, frequency and duration of drug-related adverse reactions |
Safety and tolerability of the drug will be evaluated throughout the study. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2017 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the present study is to conduct
study to evaluate its utility in oral submucosal fibrosis where there is a reasonable probability of
curcuminoids being useful / curative.
|