| CTRI Number |
CTRI/2025/09/094299 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Homoeopathic management of plantago major mother tincture on oral microbiome |
|
Scientific Title of Study
|
Role of plantago major mother tincture in aqueous solution on oral microbiome: a comparative study with conventional methods |
| 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 Bharath Kumar M |
| Designation |
POST GRADUATE |
| Affiliation |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 512 4TH FLOOR DEPARTMENT OF HOMOEOPATHIC PHARMACY
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM
KANNIYAKUMARI
TAMIL NADU 629161
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
7010023083 |
| Fax |
|
| Email |
bharathkumarbk0505@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shimmal chenthik J P |
| Designation |
PROFESSOR |
| Affiliation |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
DEPARTMENT OF HOMOEOPATHIC PHARMACY
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM
KANNIYAKUMARI
TAMIL NADU 629161
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9894070690 |
| Fax |
|
| Email |
shimmal23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shimmal chenthik J P |
| Designation |
PROFESSOR |
| Affiliation |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 512 4TH FLOOR DEPARTMENT OF HOMOEOPATHIC PHARMACY
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM
KANNIYAKUMARI
TAMIL NADU 629161
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9894070690 |
| Fax |
|
| Email |
shimmal23@gmail.com |
|
|
Source of Monetary or Material Support
|
| SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM
KANNIYAKUMARI
TAMIL NADU 629161 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Dissertation |
| Address |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL
KULASEKHARAM
KANNIYAKUMARI
TAMIL NADU 629161
|
| 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 |
| DR G JERFIN ASHA |
SARADA KRISHNA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
Room no 121 ground floor
Sarada krishna homoeopathic medical college and hospital
Kulasekharam
kanniyakumari
Tamil nadu 629161
Kanniyakumari
TAMIL NADU |
7395807700
jerfinasha@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: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL ORAL HEALTH METHOD OF OIL PULLING WITH SESAME OIL |
Participants adopt the conventional method of oil pulling using sesame oil of 10ml for rinsing as part of their daily oral hygiene routine, twice a day for 3 months. |
| Comparator Agent |
CONVENTIONAL ORAL TOOTH PASTE |
Participants continue their regular oral hygiene practices using standard conventional toothpaste, twice a day for 3 months. |
| Intervention |
PLANTAGO MAJOR HOMOEOPATHIC MOTHER TINCTURE |
Aqueous solution of plantago major homoeopathic mother tincture of 10ml as interventional method as their primary oral mouthwash which has 1ml of plantago major mother tincture in 9ml of aqueous solution twice a day for a duration of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged from 18 to 70 years
Individual with mild to moderate gingivitis or plaque index
Ability to provide informed consent |
|
| ExclusionCriteria |
| Details |
Participants aged less than 18 and above 70 years
Advanced periodontal diseases or other severe oral health issues
Any known allergies to plantago or any components of the tincture
Pregnant or breastfeeding individuals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CHANGE IN THE MICROBIAL DIVERSITY AND LOAD
REDUCTION IN PLAQUE INDEX GINGIVAL INDEX AND BLEEDING ON PROBING
|
CHANGE IN THE MICROBIAL DIVERSITY AND LOAD
REDUCTION IN PLAQUE INDEX GINGIVAL INDEX AND BLEEDING ON PROBING
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
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
|
Maintaining oral health is essential for preserving the balance of the oral microbiome and preventing both dental and systemic diseases Conventional mouthwashes such as chlorhexidine are widely used but often associated with side effects like staining altered taste and microbial resistance Plantago major a medicinal plant with known antiinflammatory antimicrobial and woundhealing properties presents a promising alternative for natural oral care This experimental study investigates the clinical efficacy and patient acceptability of an aqueous solution of Plantago major mother tincture compared to conventional oral hygiene methods including toothpaste and oil pulling The study was conducted at Sarada Krishna Homoeopathic Medical College Tamil Nadu involving 30 participants aged 10 to 70 years Participants were randomly divided into three groups Group 1 used an aqueous solution of Plantago major 1:9 dilution as a primary oral hygiene agent Group 2 used conventional toothpaste and Group 3 practiced oil pulling with sesame oil Baseline and followup assessments included clinical indices Plaque Index PI Gingival Index GI and Bleeding on Probing BOP as well as oral microbiome sampling and patientreported outcome surveys on taste ease of use and side effects The expected outcome is that Plantago major will demonstrate comparable or superior clinical efficacy to conventional methods with significant reductions in PI GI and BOP scores Additionally it is anticipated that patients will report fewer side effects and higher compliance with the herbal solution The intervention may also influence microbial diversity in a favorable direction without disrupting beneficial flora By addressing existing research gaps in comparative efficacy and patient perception this study aims to validate Plantago major as a viable natural alternative to chemical mouthwashes and promote its role in integrative oral healthcare |