| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratisAraNam, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¤®à¥ | (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 | | 2 | Comparator 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. |