| CTRI Number |
CTRI/2016/05/006973 [Registered on: 31/05/2016] Trial Registered Retrospectively |
| Last Modified On: |
29/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management of Decreased Mouth Opening due Tobacco Chewing. |
|
Scientific Title of Study
|
Further study on ayurvedic management of oral submucous fibrosis(osmf) |
| Trial Acronym |
amosmf |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saumya Gupta |
| Designation |
Research Scholar |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7405403096 |
| Fax |
|
| Email |
saumya0320@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D B Vaghela |
| Designation |
Assistant Professor |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
ASSISTANT PROFESSOR
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar
GUJARAT
361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saumya Gupta |
| Designation |
Research Scholar |
| Affiliation |
IPGT AND RA, G.A.U. JAMNAGAR |
| Address |
DEPT. OF SHALAKYA TANTRA IPGT AND RA, G.A.U. JAMNAGAR
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7405403096 |
| Fax |
|
| Email |
saumya0320@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar – 361008 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATION TEACHING AND RESEARCH IN AYURVEDA |
| Address |
INSTITUTE FOR POST GRADUATION TEACHING AND
RESEARCH IN AYURVEDA OPP. 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 |
| Saumya Gupta |
Opd No.9,Oro Dental,Department of Shalakya,I.P.G.T. AND R.A.,Jamnagar. |
Institute for Post
Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar –
361008 Jamnagar
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
7405403096
saumya0320@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
decreased mouth opening ie oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A |
First of all Erandbhristha Haritaki 5 to 10gms H.S.will be given for Kosthasuddhi for 3 days followed by Shadabindu Taila Shodhan Nasya 4 to 6 drops for 5 days.
Madhu-pippalyadi Yoga 3 to 6gms BD for Pratisarana for 45 days.
Nishadi Taila 15 to 20ml BD for Kavala for 45 days.
Rasayana Yoga 6 gms BD orally for 45 days.
|
| Comparator Agent |
group B |
Physiotherapy that is mouth opening exercise and Antioxidants with multivitamin capsules- Becousules-Z -1 capsule OD after meal will be given for 45 days. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients having clinical signs and symptoms of OSMF-blanching and stiffness of oral mucosa, trismus, burning sensation in mouth, intolerance to eating hot and spicy foods, repeated vesicular eruption and ulceration on the bucal mucosa, palate, and pillars; reduced mobility of soft palate and tongue, loss of gustatory sensation etc.
Interincisal distance between 15mm-40mm.
|
|
| ExclusionCriteria |
| Details |
Extensive fibrosis of all the oral mucosa, severe trismus with an interincisal distance of less than 15mm.
Disease is most advanced with premalignant and malignant changes.
Generalized fibromatosis.
Oral manifestation of scleroderma.
Oral lichen planus.
Pale oral mucosa of anemia.
Chronic debilitating conditions like DM, HT, HIV etc.
Patients not willing to give up habits of gutkha, pan-masala, mawa, tobacco, betel quid or betel nut chewing. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in interincisal distance |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of oral submucous fibrosis |
45 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
20/02/2015 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
no |
|
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 chronic debilitating disease of the oral cavity resulting
from habits like smoking, alcoholism, mawa, pan-masala, gutkha, tobacco, betel
nut and betel quid chewing. In Group A First
of all Erandbhristha Haritaki will be given for Kosthasuddhi for
3 days followed by Shadabindu Taila Shodhan Nasya for 5 days.
After that following treatment will be given simultaneously for 45 days.
· Madhu-pippalyadi Yoga for
Pratisarana.
·
Nishadi
Taila for Kavala.
RasayanaYoga
orallyIn Group B Physiotherapy and Antioxidants
with multivitamin capsules becosules-Z will be given. |