CTRI Number |
CTRI/2019/09/021402 [Registered on: 25/09/2019] Trial Registered Prospectively |
Last Modified On: |
17/09/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
AYURVEDA HERBAL APPLICATION THERAPY AND GARGLING THERAPY IN DIABETIC PERIODONTITIS. |
Scientific Title of Study
|
A LONGITUDINAL OBSERVATIONAL STUDY ON THE EFFECT OF GAURASARSHAPA LEPANA AND LAKSHADI TAILA GANDUSHA IN DIABETIC PERIODONTITIS. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR CHAYA C |
Designation |
PG SCHOLAR |
Affiliation |
GOVERNMENT AYURVEDA MEDICAL COLLEGE |
Address |
DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO. 9, GOVERNMENT AYURVEDA MEDICAL COLLEGE, DHANVANTARI ROAD, BANGALORE-560009
Bangalore KARNATAKA 560009 India |
Phone |
9353972678 |
Fax |
|
Email |
chayaambika@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR AHALYA S |
Designation |
PROFESSOR |
Affiliation |
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE |
Address |
DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO. 9, GOVERNMENT AYURVEDA MEDICAL COLLEGE, DHANVANTARI ROAD, BANGALORE-560009
Bangalore KARNATAKA 560009 India |
Phone |
9845458563 |
Fax |
|
Email |
principalgamc9@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR CHAYA C |
Designation |
PG SCHOLAR |
Affiliation |
GOVERNMENT AYURVEDA MEDICAL COLLEGE |
Address |
DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO. 9, GOVERNMENT AYURVEDA MEDICAL COLLEGE, DHANVANTARI ROAD, BANGALORE-560009
KARNATAKA 560009 India |
Phone |
9353972678 |
Fax |
|
Email |
chayaambika@gmail.com |
|
Source of Monetary or Material Support
|
DR CHAYA C |
SRI JAYACHAMARAJENDRA INSTITUTE OF INDIAN MEDICINE HOSPITAL, SHALAKYA TANTRA OPD, ROOM NO.9, GOVERNMENT AYURVEDA MEDICAL COLLEGE CAMPUS, BANGALORE-09 |
|
Primary Sponsor
|
Name |
DR CHAYA C |
Address |
DEPARTMENT OF PG STUDIES IN SHALAKYA TANTRA, SHALAKYA TANTRA OPD, ROOM NO. 9, GOVERNMENT AYURVEDA MEDICAL COLLEGE, DHANVANTARI ROAD, BANGALORE-560009 |
Type of Sponsor |
Other [SELF] |
|
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 CHAYA C |
SRI JAYACHAMARAJENDRA INSTITUTE OF INDIAN MEDICINE HOSPITAL |
SHALAKYA TANTRA OPD, ROOM NO. 9, GOVERNMENT AYURVEDA MEDICAL COLLEGE CAMPUS, DHANVANTARI ROAD, BANGALORE-560009 Bangalore KARNATAKA |
9353972678
chayaambika@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT AYURVEDA MEDICAL COLLEGE, BANGALORE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
1. GAURASARSHAPA KALKA
2. LAKSHADI TAILA |
1. GAURASARSHAPA LEPA, ONCE IN A DAY FOR 15 DAYS.
2. LAKSHADI TAILA GANDUSHA ONCE IN A DAY FOR 15 DAYS. |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. SUBJECTS WITH TYPE 2 DIABETES MELLITUS.
2. SUBJECTS WITH GOOD GLYCEMIC CONTROL.
3. SUBJECTS WITH DIABETIC PERIODONTITIS SIGNS AND SYMPTOMS. |
|
ExclusionCriteria |
Details |
1. JUVENILE DIABETES.
2. PERIODONTITIS HAVING NEOPLASIA.
3. PATIENTS ON DENTURES.
4. HAEMORRHAGIC DISORDERS.
5. IMMUNE DEFICIENCY DISORDERS LIKE HIV.
6. PREGNANT AND LACTATING WOMEN. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
GINGIVAL INDEX SCORE |
22 DAYS |
|
Secondary Outcome
|
Outcome |
TimePoints |
TOOTH MOBILITY SCORE |
22 DAYS |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
27/09/2019 |
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="5" 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)?
|
Brief Summary
|
6.
BRIEF RESUME OF THE INTENDED WORK Diabetes
and periodontitis are common chronic diseases in the world and abundant
epidemiological evidence implies a bidirectional relationship between these two
diseases. Diabetic mellitus is recognized as an important risk factor for most
severe and progressive periodontitis infection or lesion resulting in the
destruction of tissue and supporting bone that forms
the attachment around the tooth. Periodontal disease has been reported as the 6th
complication of diabetic mellitus.1
Periodontal disease is
prevalent both in developed and developing countries and affects about 20-50%
of global population. In Type 2
diabetic individuals with severe form of periodontal disease have 3.2 times
greater mortality risk. Untreated chronic periodontitis is responsible for
tooth loss in majority of the cases. In this study it is targeted in
managing periodontitis while giving importance with maintaining better glycemic
control.
In Ayurveda there is no direct reference
for Diabetic periodontitis. But the symptoms explained are correlated with upakusha. (Symptoms are danthaveshteshu daha, paka, chaladantha, rakthasrava, pootimuka).
Dantamala is one of the prameha
poorvarupa which is quoted by susruta
in nidana sthana.
Gandusha
and lepana are proved to be effective
in mukha roga and its
complication.They has few merits like: cost effective since no major
infrastructure is required, less intervention in manual support, adoptable at
home/clinical level. Hence in present study an effort is made to observe the
effect of gaurasarshapa lepana and gandusha through lakshadi taila in diabetic
periodontitis.
HYPOTHESIS
1.
Null hypothesis – Gaurasarsapa lepana
and lakshadi taila gandusha has no
significant result in diabetic periodontitis
2. Alternative hypothesis- Gaurasarsapadi
lepana and lakshadi gandusha has
significant result in diabetic periodontitis.
|