| CTRI Number |
CTRI/2025/04/085934 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of Homeopathy in the treatment of Periodontitis with Diabetes |
Scientific Title of Study
Modification(s)
|
Investigating the Impact of Homeopathic Therapy on Clinical, Metabolic Control, and Systemic Inflammatory Markers in Periodontitis Patients with Diabetes: A Randomized Multi-Arm Clinical Trial. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek N |
| Designation |
Dean Dental SRM Kattankulathur Dental College and Hospital ,Tamil Nadu |
| Affiliation |
SRM Kattankulathur Dental College and Hospital , SRM IST, Kattankulathur, Tamil Nadu, India |
| Address |
Room No.1 SRM Kattankulathur Dental College and Hospital Mahatma Gandhi road Potheri SRM Nagar
Chennai
TAMIL NADU
603203
India |
| Phone |
9444360303 |
| Fax |
|
| Email |
vivekn@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek N |
| Designation |
Dean Dental SRM Kattankulathur Dental College and Hospital ,Tamil Nadu |
| Affiliation |
SRM Kattankulathur Dental College and Hospital , SRM IST, Kattankulathur, Tamil Nadu, India |
| Address |
Room No.1 SRM Kattankulathur Dental College and Hospital Mahatma Gandhi road Potheri SRM Nagar
Chennai
TAMIL NADU
603203
India |
| Phone |
9444360303 |
| Fax |
|
| Email |
vivekn@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varanasi Roja |
| Designation |
Research officer(H)/S-3 |
| Affiliation |
Central Council for Reseach in Homoeopathy |
| Address |
Room No.315 Central Council for Reseach in Homoeopathy Jawaharlal Nehru Bhartiya Chikitsa Avum Homoeopathy Anusandhan Bhawan 61-65 Institutional Area opp D block Janakpuri New Delhi
West
DELHI
110058
India |
| Phone |
9999454036 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No.315 Central Council for Research in Homoeopathy,(Ministry of Ayush) Jawaharlal Nehru Bhartiya Chikitsa Avum Homoeopathy Anusandhan Bhawan 61-65,Institutional Area opp. DBlock, Janakpuri New Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homoeopathic Anusandhan Bhawan, 61-65 Institutional area opposite D-block, Janakpuri New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Vivek N |
SRM Kattankulathur Dental College and Hospital |
Room No.1 SRM Kattankulathur Dental College and Hospital Mahatma Gandhi road Potheri SRM Nagar
Chennai
TAMIL NADU |
9444360303
vivekn@srmist.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL&RESEARCH CENTRE IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 NSPT+ PLACEBO |
Receives NSPT along with a placebo indistinguishable from the homeopathic remedy in appearance, taste, and smell. The placebo will be administered orally in centesimal potencies of 6C, 30C, 200C, or 1M, once or twice daily, for a duration of 6 months.. |
| Intervention |
Group 2 (NSPT + IH) |
Receives Individualized homeopathic medicine in centesimal potency customized to each patient, along with non-surgical periodontal therapy (NSPT) comprising of scaling and root planing that prevents plaque formation and reduces inflammation in gums. The IH will be administered orally in centesimal potencies of 6C, 30C, 200C, or 1M, once or twice daily, for 6 months. |
| Intervention |
Group 3 (NSPT + IH + Placebo mouth wash) |
Receives NSPT and Individualized homeopathic medicine along with a placebo mouthwash, indistinguishable from the Calendula mouthwash in appearance, taste, and smell as a mouthwash. The Placebo mouthwash 8ml will be administered orally, and rinse mouth twice daily for 6 months, and IH will be administered orally in centesimal potencies of 6C, 30C, 200C, or 1M, once or twice daily, for 6 months. |
| Intervention |
Group 4 (NSPT + IH+ Calendula mouth wash |
Receives NSPT and Individualized homeopathic medicine along with a 2ml Calendula mouthwash diluted in 6ml of distilled water, rinses their mouth once in the morning and once in the evening for the study period. The IH will be administered orally in potencies of 6C, 30C, 200C, or 1M, once or twice daily, for 6 months. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged 30 to 70 years, diagnosed with Stage II, III & IV Periodontitis
2. HbA1c eligibility to include both controlled or uncontrolled diabetic patients.
3. No modification in diabetic medication in the last three months before or during the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients affected with any systemic conditions known to exert effects of any kind in the study or on the assessed parameters.
2. Patients diagnosed with type 1 diabetes
3. Current Smokers and recent former smokers.
4. Pregnant and lactating females.
5 Any form of periodontal therapy in the previous 6 months.
6. Use of any antimicrobials in the last three months.
7. Any other infections (e.g., Common cold, influenza, ENT infections, etc.) may affect any change in the considered study parameters.
8. Patients undergoing or have undergone radiation therapy in the recent past.
9. Long-standing infections of any kind and patients on chemotherapy
10. Uncontrolled hypertension.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bleeding on Probing (BOP)
Probing Pocket Depth (PPD)
Clinical Attachment Level (CAL)
|
baseline, month1, month 3 & month6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting blood glucose levels and HbA1c |
Baseline, month1, month3, month6 |
| Analysis of specific inflammatory biomarkers (IL-1Beta, IL-6, TNF-alpha, IL-17, and MMP-8) in saliva samples |
Baseline,month1, month 3 & month6 , |
| Measurement of PINK1/PARKIN proteins in serum samples to explore their levels and any alterations between intervention and control groups |
Baseline, month1, month 3 & month6 |
| To assess the Oral Health-Related Quality of Life (OHRQoL), using Oral Health Impact Profile (OHIP). |
Baseline, month1, month 3 & month6 |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
01/06/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Periodontitis and Diabetes mellitus are prevalent chronic conditions worldwide. Periodontitis is an inflammatory disease associated with dysbiotic plaque biofilms, leading to the progressive deterioration of the tooth-supporting structures. Homeopathy is believed to restore the body’s vital energy balance, promoting self-healing. It is a therapeutic system based on the principle of similarity and uses medicines from all the kingdoms of nature (mineral, vegetable, and animal). Therefore, this study aims to employ a well-designed clinical trial to evaluate the effectiveness of homeopathy as an adjunct to non-surgical periodontal therapy (NSPT) in diabetic patients with stage III and severe periodontitis. This double-blinded Randomized Four Arm Clinical Trial will be conducted at the Department of Periodontology, SRM Kattankulathur Dental College and Hospital. A total of 400 participants aged 30 to 70 years, were diagnosed with Stage III & IV Periodontitis, having type 2 diabetes HbA1c with 7.5-8%. There is no modification in diabetic medication in the last three months before or during the study will be included. All participants will receive ant-diabetic medicines as standard care and subsequently, the participants will be randomized into four groups a) Group 1 (NSPT +Placebo) b) Group 2 (NSPT + IH) c) Group 3 (NSPT + IH + Placebo mouthwash)d) Group 4 (NSPT + IH+ Calendula mouthwash). The study’s primary objective is to evaluate the effectiveness of individualized homeopathic remedies (IH) compared to placebo in reducing the severity of periodontitis in patients with type 2 diabetes mellitus (T2DM) diagnosed with Stage III and IV disease. The secondary objective is evaluating the homeopathic medicine-mediated mitigation of serum biomarkers for glycemic parameters, such as Fasting blood glucose levels, HbA1c, and other clinical values, between the intervention and control groups , to investigate the impact of homeopathic medicine on the levels of specific inflammatory biomarkers (IL-1beta, IL-6, TNF-alpha, IL-17, and MMP-8) between the groups at defined time points in saliva samples, to evaluate the influence of homeopathic medicine on the levels of PINK1 /PARKIN Proteins between the intervention and control groups in serum samples and to assess the Oral Health-Related Quality of Life (OHRQoL), using Oral Health Impact Profile (OHIP)
|