| CTRI Number |
CTRI/2020/11/028998 [Registered on: 09/11/2020] Trial Registered Prospectively |
| Last Modified On: |
07/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda treatment for Mouth ulcer |
|
Scientific Title of Study
|
EFFICACY OF JATYADI KWATHA GANDUSHA IN MANAGEMENT OF PITTAJA MUKHAPAKA W.S.R TO APHTHOUS ULCER - A RANDOMIZED 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 |
Dr Queency Evangaline Sutnga |
| Designation |
PG scholar |
| Affiliation |
KAHERs Shri.B M Kankanawadi Ayurveda Mahavidhyalaya |
| Address |
Department of Shalakya Tantra KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
9862620929 |
| Fax |
|
| Email |
queencysutnga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Angadi |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya |
| Address |
Department of Shalakya Tantra KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
7411213286 |
| Fax |
|
| Email |
savitaangadi.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Angadi |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya |
| Address |
Department of Shalakya Tantra KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
7411213286 |
| Fax |
|
| Email |
savitaangadi.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research owned Shri B M Kankanawadi Ayurveda Mahavidhyalaya and KLE Ayurveda Hospital |
|
|
Primary Sponsor
|
| Name |
DrQueency Evangaline Sutnga |
| Address |
PG Scholar Department of Shalakya Tantra KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya Shahapur Belagavi Karnataka |
| Type of Sponsor |
Other [SELF SPONSORED PG DISSERTATION WORK] |
|
|
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 Queency Evangaline Sutnga |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya and Hospital |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya and Hospital Shahapur Shalakya Department OPD Room no 26
Belgaum
KARNATAKA |
9862620929
queencysutnga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K120||Recurrent oral aphthae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JATYADI KWATHA GANDUSHA |
Jatyadi kwatha Gandusha will be done for 15 days |
| Comparator Agent |
TRIPHALA KWATHA GANDUSHA |
Triphala kwatha Gandusha will be done for 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient presenting with signs and symptoms of Pittaja Mukhapaka
2 Age group between 18-60 years, irrespective of sex, religion, occupation
|
|
| ExclusionCriteria |
| Details |
1 Traumatic mouth ulcer.
2 Chronic ulcers due to Diabetes, Tuberculosis, Herpes, AIDS, Lichen planus, auto-immune disorder or any systemic illness which obstruct the duration of course of treatment.
3 Disorder which contraindicated for Gandusha
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Jatyadi Kwatha Gandusha maybe effective in Management of Pittaja Mukhapaka w s r to Aphthous ulcer |
18 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Jatyadi Kwatha Gandusha is more effective compared to Triphala kwatha Gandusha in the management of Pittaja Mukhapaka w s r to Aphthous ulcer |
BASE LINE AND TWO WEEKS |
|
|
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)
|
15/11/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is to evaluate the efficacy of Jatyadi kwatha Gandusha in the management of Pittaja Mukhapaka w s r to Aphthous ulcer and to be compared with Triphala kwatha gandusha for a period of 15days. The study will be conducted at KAHERs Shri B M Kankanawadi Ayurveda Mahavidhyalaya and Research Centre owned KLE Ayurved Hospital Shahapur Belagavi Karnataka India.The Expected outcome is to reduce the sign and symptoms of Pittaja Mukhapka w s r to Aphthous Ulcer and to prevent its reoccurence. |