| CTRI Number |
CTRI/2017/12/010863 [Registered on: 13/12/2017] Trial Registered Prospectively |
| Last Modified On: |
12/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral submucous fibrosis management through ayurveda |
|
Scientific Title of Study
|
A Further Study On Ayurvedic Management Of Oral submucous Fibrosis - An Open Labelled Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Kumar |
| Designation |
Research scholar |
| Affiliation |
Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University Jamnagar |
| Address |
Department of Shalakya Tantra Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Department of Shalakya Tantra IPGT AND RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9728560012 |
| Fax |
|
| Email |
dr.deepaksangwan92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anup B Thakar |
| Designation |
Head Department of Panchkarma IPGT annd RA |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Panchkarma IPGT and RA Gujarat Ayurved University Jamnagar
Department of Panchkarma Institute for Post Graduate Teaching And Research In Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anup B Thakar |
| Designation |
Head Department of Panchkarma IPGT annd RA |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Panchkarma Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Department of Panchkarma IPGT AND RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Gradeuate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute For Post Graduate Teaching And Research In Ayurveda Gujarat Aurved University Jamnagar |
| Address |
Institute for Post Graduate Teaching And Research In Ayurveda Gujarat Ayurved University Jamnagar Opposite City B Police Station PN Marg Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Deepak Kumar |
PG Hospital IPGT and RA Jamnagar |
PG Hospital OPD Block Shalakya Dpartment OPD No. 9 IPGT and RA Jamnagar
Jamnagar
GUJARAT |
9728560012
dr.deepaksangwan92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee PGT/7/-A/Ethics/2017-18/2097 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Complaining of blanching and stiffness of oral mucosa, trismus , repeated vesicular eruption and ulceration on buccal mucosa ,burning sensation in mouth, intolerance to eat hot and spicy foods etc., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Madhupipplyadi Yoga 3-6gms two times a day for Pratisarna for 30 days
Nishadi taila kavala 15-20ml
for 30 days
Rasayana Yoga Orally 6gm two times a day before meal for 30 days
|
| Comparator Agent |
group B |
1 Physiotherapy Mouth opening exercise with the help of Top
2 Antioxidants Tablets Methylocobalamine1500 mcg
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of age group between 18years to 60 years
2 Patients having clincal signs and symptoms of Oral
3 Submucous Fibrosis like blanching and stiffness of oral mucosa repeated vascicular eruption and ulceration of buccal mucosa
4 Interincisor distance of more than 15mm |
|
| ExclusionCriteria |
| Details |
1 Patients below 18 years and above 60 years
2 Extensive fibrosis of Oral Mucosa
3 Inter incisor distance of less than 15 mm
4 Oral Lichen Planus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of oral submucous fibrosis |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of oral submucous fibrosis |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
15/02/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Oral sub mucous fibrosis OSMF is a chronic insidious process characterized by juxtaepithelial inflammation and progressive fibrosis of sub mucous tissue the lamina propria and deeper connective tissues It is also described as idiopathic scleroderma of mouth,idiopathic palatal fibrosis and sclerosing stomatitis.As the disease progresses jaws become rigid to the point that person is unable to open the mouth. The study is to evaluate the effect of Madhupipplyadi yoga pratisarna, Nishadi taila kavala and rasayana yoga orally in the management of Oral Submucous Fibrosis. |