| CTRI Number |
CTRI/2026/01/101943 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Oral Health in Prediabetes and Diabetes study consisting of total participation of 256 diabetic and prediabetic patients will be assessed through oral hygiene index, gingival index, etc. out of which 80 will be selected randomly and assigned to 2 groups of different medications. |
|
Scientific Title of Study
|
Assessment Of Oral Health Status in Prediabetic and Diabetic Patients And Evaluation of the Efficacy Of Dashansamskara toothpaste – A Randomised Controlled Comparative Clinical Study |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SYED FAHEEM ALI |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA , DELHI |
| Address |
ODD 102 and 108, 1st floor, Hospital Block, All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
9205105727 |
| Fax |
|
| Email |
alisyedfaheem52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. NARAYAN BAVALATTI |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA , DELHI |
| Address |
Room no 512 ,5th floor, Academic block, All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
9650715615 |
| Fax |
|
| Email |
eyenimi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SYED FAHEEM ALI |
| Designation |
PG SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA , DELHI |
| Address |
OPD 102 and 108, 1st floor, All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
9205105727 |
| Fax |
|
| Email |
alisyedfaheem52@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF AYURVEDA , DELHI |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi |
| 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 |
| SYED FAHEEM ALI |
ALL INDIA INSTITUTE OF AYURVEDA , NEW DELHI |
OPD 102 and OPD 108, 1st floor , Hospital block, All India Institute of Ayurveda, Mathura Road, Gautam Puri, Sarita Vihar, New Delhi
South
DELHI |
09205105727
alisyedfaheem52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z000||Encounter for general adult medical examination. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DASHANSAMSKARA TOOTHPASTE, Reference: B.Ratnawali – Mukhrogadhikar 73,74, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | FLOURIDATED TOOTHPASTE | Route Topical
Dosage 250mg
Frequency bd
Duration 30 days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of Diabetes Mellitus Type 1 & 2 duration more than one year
Prediabetic patients of Diabetes Mellitus Type 2
Age group: 30–70 years of both genders
Patients willing to give informed consent.
Patients with a minimum of 20 natural teeth present (for meaningful plaque and gingival evaluation).
HbA1c value available (Above 5.6). |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in oral health as reflected by change in Plaque Index and OHI-S amongst pre-diabetic and diabetic patients with poor oral health. |
0 day
15 day
30 day
45 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of the status of Oral Health Among Prediabetic & Diabetic Patients through a survey study .
To develop toothpaste formulation for dashansamskara toothpaste. |
0,15,30,45 day |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
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 |
|
Date of First Enrollment (India)
|
18/04/2026 |
| 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="0"
Months="6"
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
|
A total of 256 participants are enrolled and categorised into prediabetic and diabetic groups. Baseline oral examinations are carried out to record common oral health problems associated with dysglycaemia, such as gingival inflammation, periodontal status, plaque accumulation and dental caries. Participants are then randomly allocated to use either Dashansamskara toothpaste (intervention) or a standard comparator toothpaste (control), under supervised instructions for routine oral hygiene practices. Outcomes are assessed by comparing pre- and post-intervention oral health indices across groups. The study is designed to determine whether Dashansamskara toothpaste offers superior improvement in periodontal and oral hygiene parameters compared to conventional toothpaste, especially in individuals with impaired glucose metabolism where oral infections and periodontal disease risk are higher. Overall, the study provides clinical evidence on the association between prediabetes/diabetes and oral health and evaluates a traditional formulation toothpaste as a supportive oral care measure in these populations. |