| CTRI Number |
CTRI/2025/08/093260 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of herbal powdere in oral conditions- gum disease(Gingivitis) |
|
Scientific Title of Study
|
An open label randomized controlled clinical study to evaluate the effect of kanadi choorna pratisarana in sheetada vis a vis gingivitis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kushala A S |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD NO 4, Department of Shalakya tantra JSS Ayurveda Medical College and Hospital
#41/E, Lalithadripura road,
Mysuru
OPD NO 4, Department of Shalakya tantra JSS Ayurveda Medical College and Hospital
#41/E, Lalithadripura road,
Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
8277351933 |
| Fax |
|
| Email |
kushalgowdaas888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gavimath Shivanand |
| Designation |
Professor and HOD |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD NO 4, Department of Shalakya tantra JSS Ayurveda Medical College and Hospital
#41/E, Lalithadripura road,
Mysuru
OPD NO 4, Department of Shalakya tantra JSS Ayurveda Medical College and Hospital
#41/E, Lalithadripura road,
Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9448211075 |
| Fax |
|
| Email |
shiva.shalakya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gavimath Shivanand |
| Designation |
Professor and HOD |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD NO 4, Department of Shalakya tantra JSS Ayurveda Medical College and Hospital
#41/E, Lalithadripura road,
Mysuru
OPD NO 4, Department of Shalakya tantra JSS Ayurveda Medical College and Hospital
#41/E, Lalithadripura road,
Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9448211075 |
| Fax |
|
| Email |
shiva.shalakya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra JSS Ayurveda Hospital, #41/E Lalitadripura road, Mysuru, Karnataka 570028.
JSS Dental Hospital, Shivarathreeshwara Nagar, Bannimantap, Mysuru, Karnataka 570015. |
|
|
Primary Sponsor
|
| Name |
Dr Kushala A S |
| Address |
Department of Shalakya tantra JSS Ayurveda Medical College and Hospital
#41/E, Lalithadripura road,
Mysuru |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kushala A S |
JSS Ayurveda Medical College And Hospital |
41/E Lalithadripura road
mysuru
Mysore
KARNATAKA |
8277351933
kushalgowdaas888@gmail.com |
| Dr Kushal A S |
JSS Dental Hospital, Shivarathreeshwara Nagar, Bannimantap, Mysuru, Karnataka 570015. |
JSS Dental Hospital, Shivarathreeshwara Nagar, Bannimantap, Mysuru, Karnataka 570015.
Mysore
KARNATAKA |
8277351933
kushalgowdaas888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, JSS Ayurveda Medical College, Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K050||Acute gingivitis. Ayurveda Condition: SITADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kanadi choorna, Reference: yogaratnakara, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | control group | scaling of teeth, chlorhexidine gluconate 1.0% mouth gel twice daily applied all over gingiva, when the oral cavity is filled with saliva , wash mouth with water |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who have complaints of cardinal features of Gingivitis like Redness or bluish discoloration of gingiva, Swollen gingiva, Halitosis, Bleeding on provocation and plaque deposition, irrespective of gender, caste, religion & socioeconomic status.
Periodontal probing depth (PPD) not exceeding 3mm
Subjects who are willing to participate after signing the informed consent. |
|
| ExclusionCriteria |
| Details |
Subjects with haematological disorders.
Subjects having any systemic diseases.
Pregnant and lactating woman.
Subjects with oral cavity diseases like Oral Cancer and Malignancy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, swelling, halitosis and discolouration of gingiva. |
35 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Inflammation of the gingival mucosa is called as Gingivitis. It commonly occurs because of plaque or bacteria that accumulates on the teeth, this is termed as plaque -induced Gingivitis. Signs and symptoms include tender gums, bleeding from gums while brushing, halitosis, inflammation and receding gums. Chlorhexidine (CHX) gluconate mouth gel (1.0%) is the most effective anti-plaque and anti-Gingivitis dental medicine. It is reported that application of 1.0% Chlorhexidine gluconate oral gel twice a day inhibits the formation of dental plaque and also proven that it act as anti-Gingivitis. The Kanadi choorna drugs having properties like anti inflammation, antibacterial, antimicrobial and antioxidant. Pratirasana of Kanadi choorna helps in alleviating the symptoms of Sheetada and it has Kaphavatahara, Sothahara, and Vranagna properties .Also the mode of administration of medicine is easy, convenient and non-invasive in nature. Considering the above factors, this study is taken up to evaluate the effect of Kanadi choorna Pratisarana in the management of Sheetada(Gingivitis). |