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CTRI Number  CTRI/2024/03/063433 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study of Kasisadi Churna Pratisaran Along With Madhu and Chlorhexidine Gluconate 1 % Gel in The Management of Sheetad W.S.R. to Gingivitis 
Scientific Title of Study   A randomized comparative clinical trial to evaluate the effectiveness of Kasisadi Churna Pratisaran along with Madhu and Chlorhexidine Gluconate 1 % gel in the management of Sheetad w.s.r. to Gingivitis 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajendra Singh Patel 
Designation  PhD Scholar 
Affiliation  Government ayurved college and hospital 
Address  Department of Shalakya Tantra Room no 37 1st Floor Government Ayurveda College & Hospital, Raje Raghuji Nagar, Shakkardara Chowk,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  7000797030  
Fax    
Email  dr.rspatel17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Dhakate 
Designation  Associate Professor 
Affiliation  Government ayurved college and hospital 
Address  Department of Shalakya Tantra Room no 37 1st Floor Government Ayurveda College & Hospital, Raje Raghuji Nagar, Shakkardara Chowk,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9860517302  
Fax    
Email  drvijaydhakate6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajendra Singh Patel 
Designation  PhD Scholar 
Affiliation  Government ayurved college and hospital 
Address  Department of Shalakya Tantra Room no 37 1st Floor Government Ayurveda College & Hospital, Raje Raghuji Nagar, Shakkardara Chowk,Nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  7000797030  
Fax    
Email  dr.rspatel17@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College & Hospital, Nagpur 
 
Primary Sponsor  
Name  Government Ayurveda College and Hospital 
Address  Department of Shalakya Tantra Room no 37 1st Floor Government Ayurveda College & Hospital, Raje Raghuji Nagar, Shakkardara Chowk,Nagpur 
Type of Sponsor  Research institution and hospital 
 
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 Rajendra Singh Patel  Government Ayurveda College & Hospital  Department of Shalakya Tantra Room no 37 1st Floor , Raje Raghuji Nagar, Shakkardara Chowk,Nagpur
Nagpur
MAHARASHTRA 
7000797030

dr.rspatel17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurveda College & Hospital Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy human 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Sarangdgar Samhita, Procedure details: Kasisadi Churna Pratisarna with Madhu twice a day )
(1) Medicine Name: Kasisadi Churna, Reference: Yogratnakar, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 14 Days
2Comparator Arm (Non Ayurveda)-Chlorohexidine Gluconate 1%Chlorohexidine Gluconate 1% 5gram twice a day
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Any patients having Age group between 18 –60.
2. The patients who are clinically diagnosed as Gingivitis.
3. Patients who are willing and ready to give consent for this study.
 
 
ExclusionCriteria 
Details  1. Ca mouth and other cancer
2. Congenital deformity like cleft palate etc.
3. Patients with pus discharge from gums.
4. Patients with periodontal pocket.
5. Patients having any systemic disease, which cause gingivitis.
6. Pregnant women, Patients suffering from Sheetad due to any secondary cause like HIV, TB.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Kasisadi Churna Pratisaran with Madhu and Chlorhexidine gluconate 1% gel in the management of Sheetad w.s.r. to Gingivitis.
 
14 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
To study the details of Sheetad & Gingivitis according to Ayurveda & modern science.
To study the mode of action of Kasisadi Churna Pratisaran along with Madhu & Chlorhexidine gluconate 1% Gel on Sheetad.

 
14 DAYS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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/ Phase 3 
Date of First Enrollment (India)   15/03/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Gingivitis has a high prevalence among societies. The inflammation of the gums (gingivitis) normally does not create any significant issues at first. However, it has the potential to migrate to other sections of the periodontium (the soft tissue and bone that anchors our teeth) and cause injury. Periodontitis is the nothing but the for periodontal inflammation. If left untreated, it can become a more serious condition known as periodontitis. Periodontitis can cause teeth to loosen over time. Gingivitis can be avoided with proper dental hygiene. In order to prevent periodontitis from worsening, it is also critical to continue taking proper care of your teeth after therapy. However, adequate time of brushing, efficient cleaning of all tooth surfaces and regular oral hygiene is hard to achieve for every individual due to variations in oral health practices which accounts for high prevalence of gingivitis. Therefore, additional approaches such as dentifrices and mouthwashes containing chemical or herbal agents are suggested. Herbal drugs  are gaining attention as both preventive as well as curative for plaque control approaches and as adjunctive treatments in various dental and gums problem. Hence Kasisadi Churna Pratisaran is taken for the study.

 
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