| CTRI Number |
CTRI/2026/01/102572 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Herbal Gel and Metformin Gel on Gum Health and Gum Blood Sugar Levels in Diabetic Patients With Gum Problems After Gums Treatment. |
|
Scientific Title of Study
|
Comparative Evaluation of Effectiveness of Momordica Charantia Gel and Metformin Gel As An Adjunct To Scaling and Root Planing on Gcf IL-6, TNF Alpha and Gingival Crevicular Blood Glucose level In Stage III Periodontitis With Type 2 Diabetes Mellitus -A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Tekale |
| Designation |
PhD student |
| Affiliation |
Government Dental College and Hospital, Nagpur. |
| Address |
Dr Archana Tekale Nagrik, Government medical College buldana 443001
Nagpur
MAHARASHTRA
443001
India |
| Phone |
9422926275 |
| Fax |
|
| Email |
nagrik.archana83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
Professor and head of the department of periodontology. |
| Affiliation |
government dental college and hospital nagpur |
| Address |
Government dental college and hospital Nagpur, Maharashtra
Nagpur
MAHARASHTRA
440001
India |
| Phone |
9422254404 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
professor and head of the department of periodontology. |
| Affiliation |
government dental college and hospital nagpur |
| Address |
government dental college and hospital, department of periodontivs, room no 217 Nagpur,
Nagpur
MAHARASHTRA
440001
India |
| Phone |
9422254404 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical College and hospital, Buldana, Maharashtra.pin 443001 |
|
|
Primary Sponsor
|
| Name |
Dr Archana Tekale |
| Address |
Government medical College and hospital Buldana, Maharashtra 443001 |
| Type of Sponsor |
Other [NIL] |
|
|
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 Archana Tekale |
Government medical College and hospital Buldana |
Dental department, Government mediacal college and Hospital
Government Medical College and hospital Dental department,Buldana.
Buldana
MAHARASHTRA |
9422926275
nagrik.archana83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government dental college and hospital ,Nagpur Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | metformin | 1% metformin gel | | 2 | Comparator Arm (Non Ayurveda) | | - | metformin | 1% metformin gel | | 3 | Comparator Arm (Non Ayurveda) | | - | Metformin | 1% metformin gel placed in gingival sulcus once only | | 4 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: momordica charantia , Reference: NA, Route: Oral, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients with stage III periodontitis with controlled type II diabetes mellitis since 5 years with HbA1c levels , sites having probing depth of more than or equal to 6 mm, clinical attachment loss of more than or equal to 5mm, radiographic bone loss more than one third of the root. |
|
| ExclusionCriteria |
| Details |
patients with medical disorders such as cardiovascular , renal, poorly controlled diabetes , liver disease , malignancy, radiotherapy. patients with recent history o or presence of acute or chronic infection. individuals with history of vtobacco chewing, smoking. pregnant woman or lactating mother. in ability of the person yo co operate because of their physical or mental in ability bor daily routine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gingival crevicular fluid levels of IL-6, TNF-Alpha and gingival crevicular blood glucose levels after treatment with metformin gel and momordica charantia gel in diabetes mellitis patients |
At baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
12/02/2026 |
| 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="2"
Months="0"
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
|
This study is planned to evaluate the effectiveness of momordica charantia herbal gel in comparison with metformin in class III Periodontitis patients having type II Diabetes Mellitis before and after scaling and root planning in gingival crevicular fluid comparing the presence of inflammatory markers . the study population is divided into three groups , and total 150 patients will be evaluated using single blind randomized controlled trial where the study subject will be blinded to the treatment assignment. The inflammatory parameters will be assessed at baseline and three months, along with this clinical parameters like plaque index, gingival index, probing depth and clinical attachment levels will be assessed . |