| CTRI Number |
CTRI/2025/07/090967 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY TO SEE EFFECT OF LAKSHA CHURNA (Laccifera lacca)ALONG WITH MADHU PRATISARAN IN THE MANAGEMENT OF DANTSHARKARA W.S.R TARTAR AFTER DANTASHARKARA NIHARANA (ULTRASONICSCALING) |
|
Scientific Title of Study
|
Open Labelled Randomised Controlled Clinical Trial To Estimate Efficacy Of Laksha Churna (Laccifera lacca)Along With Madhu Pratisaran In The Management Of Dantasharkara W.S.R Tartar After Dantsharkara Nirharn (ULTRASONICSCALING) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi kadam |
| Designation |
PG Scholar |
| Affiliation |
Sst ayurved mahavidyalay sangamner |
| Address |
Shalakyatantra opd no 3 ground floor sst Ayurved college
nashik pune highway opposite to Prasad cafe ghulewadi sangamner
Maharashtra 422605
Nashik
MAHARASHTRA
422605
India |
| Phone |
9763154900 |
| Fax |
|
| Email |
docaditikadam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi kadam |
| Designation |
PG Scholar |
| Affiliation |
Sst ayurved mahavidyalay sangamner |
| Address |
Shalakyatantr department opd no 3 sst ayurved college nashik Pune highway opposite to Prasad cafe ghulewadi sangamner
Maharashtra 422605
MAHARASHTRA
422605
India |
| Phone |
9763154900 |
| Fax |
|
| Email |
docaditikadam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi kadam |
| Designation |
PG Scholar |
| Affiliation |
Sst ayurved mahavidyalay sangamner |
| Address |
Shalakyatantr department opd no 3 sst ayurved college nashik Pune highway opposite to Prasad cafe ghulewadi sangamner
Maharashtra 422605
MAHARASHTRA
422605
India |
| Phone |
9763154900 |
| Fax |
|
| Email |
docaditikadam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra. Opd no 3 ,sst ayurved mahavidyalay sangamner nashik pune highway opp Prasad cafe ghulewadi sangamner Maharashtra pin code-422605 |
|
|
Primary Sponsor
|
| Name |
Sst Ayurved mahavidyalay sangamner |
| Address |
Shalakyatantra department
opd no 3 Nashik pune highway opposite Prasad cafe ghulewadi sangamner Maharashtra pin code 422605 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Drrekha jori |
Sst ayurved mahavidyalay sangamner |
Shalakyatantr department opd no 3 groumd floor Nashik pune highway opp Prasad cafe ghulewadi sangamner
Ahmadnagar
MAHARASHTRA |
9503197787
drrekhamatkar1912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z518||Encounter for other specified aftercare. Ayurveda Condition: DANTASARKARA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Laksha , Reference: SushrutSamhita chikitsasthana 22-36 , Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: laksha churna along with madhu pratisaran | | 2 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine gluconate gargle 0.2 % | Chlorhexidine gluconate gargle 0.2 % have to use bid for 30 days after meal |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling the diagnostic criteria which are based on sign and symptoms of dantsharkara like plaque,gum inflammation,bad breath,bleeding gums,pain |
|
| ExclusionCriteria |
| Details |
1.pregnant and lactating mothers
2.k/c/o DM HTN Malignancy
3.patient having stomatitis or mouth ulcer mobile teeth having artificial denture,crown or filling
4. Bleeding gums due to other various dental problems e.g gingivitis,wounds etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the efficacy of laksha churna along with madhu pratisaran in the management of dantsharkara w.s.r tartar after dantasharkara niharana (ultrasonic scaling) |
4wks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)TO review literature about dantsharkara in different Samhitas
2)To compare efficacy Of laksha churna along with madhu pratisaran & chlorhexidine gluconate gargle 0.2 %in dantsharkara |
Patient should follow upto 4wks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/07/2025 |
| 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="1" |
|
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
|
This is a randomized clinical controlled trial to estimate the efficacy of laksha churna along with madhu pratisaran in the management of dantsharkara w.s.r tartar after dantsharkara nirharn (ULTRASONICSCALING).one group of 45 patient treated with laksha churn along with madhu pratisaran for 30 days and other group of 45 patient treated with chlorhexidine gluconate gargle 0.2 % for 30 days.observation. will be drawn from the outcome of treatment |