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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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