| CTRI Number |
CTRI/2019/10/021644 [Registered on: 15/10/2019] Trial Registered Prospectively |
| Last Modified On: |
27/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see the effect of Ayyrvedic drug in the management of mukhroga |
|
Scientific Title of Study
|
"A randomized comparative clinical study on the efficacy of daarvyadi qwath gandush and darvi raskriya pratisaran in the management of tridoshaja sarvasara mukhroga w.s.r to oral submucous 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 Shamsa Fiaz |
| Designation |
Professor & H.O.D |
| Affiliation |
National Institute of Ayurveda |
| Address |
Shalakya Tantra Department
National Institute of Ayurveda
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamsa Fiaz |
| Designation |
Professor & H.O.D |
| Affiliation |
National Institute of Ayurveda |
| Address |
Shalakya Tantra Department
National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shamsa Fiaz |
| Designation |
Professor & H.O.D |
| Affiliation |
National Institute of Ayurveda |
| Address |
Shalakya Tantra Department
National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate
Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate
Jaipur
Rajasthan |
| 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 |
| Dr Aparna Sharma |
National Institute of Ayurveda |
Shalakya Tantra Department
OPD no 12
Jaipur
RAJASTHAN |
8955688129
appu07@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee National institute of Ayurveda National |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Darvi Raskriya Pratisarana |
Raskriya Pratisaran 3-6 gms twice a day for 2 months |
| Intervention |
Darvyadi kwathb gandush |
Gandush 20-25 ml twice daily for 2 months |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60 years
Patient having specific symptoms of Tridoshaja sarvasara Mukha roga
Patient of either sex will be selected randomly |
|
| ExclusionCriteria |
| Details |
Individuals above 60 years and below 18years of age of either sex
Extensive fibrosis with an inter incisal distance IID <15 mm
Premalignant and malignant changes
Oral lichen planus
Chronic debilitating conditions such as DM HT HIV etc
Patients not willing to give up addiction habits of gutka ,panmasala tobacco and other narcotics
|
|
|
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 |
| To evaluate the efficacy of Darvyadi qwath gandush and darvi Raskriya pratisarana in the management of Tridoshaja Mukhroga ( Oral submucous fibrosis) |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Any adverse event reported voluntarily observed or enquired
Recurrence in signs and symptoms of sarvasara mukhroga |
2 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
Modification(s)
|
24/03/2021 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A Randomized comparative clinical study on the efficacy of Darvyadi Kwath Gandush and darvi Raskriya pratisarana in the management of Tridoshaja sarvasar Mukhroga w.s.r to Oral submucous fibrosis . The study will be randomized clinical phase 1 trial . The screened patients will be randomly divided into 2 group using computer randomization method for unbiased allocation Group A Patients will be treated with Darvyadi kwath gandush Group B patients will be treated with Darvi Raskriya Pratisarana
The Guide for this PhD thesis work has been changed to Dr Ashok Kumar, Associate Professor, The National Institute of Ayurveda, Jaipur as Dr Shamsa Fiaz, Professor, Shalakya Tantra, The National Institute of Ayurveda, Jaipur is the Co Guide |