| CTRI Number |
CTRI/2025/08/093903 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of gum bleeding, and swelling in adults |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in the treatment of gingivitis in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-2515 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujan Naskar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
8250384730 |
| Fax |
|
| Email |
drsujan4730@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujan Naskar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
8250384730 |
| Fax |
|
| Email |
drsujan4730@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Kumar Pal |
| Designation |
Professor and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9433130996 |
| Fax |
|
| Email |
drrajatkumatpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Tangra,
Kolkata |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal |
| Type of Sponsor |
Government 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 Sujan Naskar |
D N De Homoeopathic Medical College and Hospital |
OPD no. PG3 and room
no. 7 (Dental OPD), Dept. of
Homoeopathic Repertory and Case Taking,
12, Gobinda Khatick
Road, Tangra
Kolkata
WEST BENGAL |
8250384730
drsujan4730@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intuitional Ethics Committee of D N De Homoeopathic Medical College and Hospital |
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 |
Identical-looking placebos plus
concomitant care |
This group will receive placebo,
identical in appearance with the
verum. Each dose will consist of
4 cane sugar globules no. 40,
moistened with 90% v/v ethanol,
to be taken orally on clean
tongue with empty stomach;
dosage and repetition will be
decided depending upon the
individual requirement of the
cases. All sundry items will be
procured from a Good
Manufacturing Practice (GMP)
certified firm. All the enrolled patients will receive advices on general management (Oral hygiene protocol, which includes regular tooth brushing with an appropriate technique and interproximal hygiene, such as dental flossing, or the use of interproximal brushes). Duration of therapy: 2 months. |
| Intervention |
Individualized homoeopathic
medicines in centesimal
potencies plus concomitant care |
Intervention is planned as
administering indicated
homoeopathic medicines in
centesimal potencies (cH). Each
dose will consist of 4 cane
sugar globules no. 40
moistened with the indicated
medicine (preserved in 90% v/v
ethanol), to be taken orally on
clean tongue with empty
stomach; dosage and repetition
depending upon the individual
requirement of the cases.
Patients will be advised to
refrain from handling the
globules or from eating,
drinking, smoking or brushing
teeth within 30 minutes of taking
the globules and will be asked to suck the globules rather than
simply swallowing those. All the
medicines and sundry items will
be procured from a Good
Manufacturing Practice (GMP)
certified firm. All the enrolled patients will receive advices on general management (Oral hygiene protocol, which includes regular tooth brushing with an appropriate technique and interproximal hygiene, such as dental flossing, or the use of interproximal brushes). Duration
of therapy: 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 and 65 years
2. Patients suffering from Gingivitis (ICD-11: DA0B).
3. Patients of either sex or transgender.
4. Literate patients; ability to read English and/or Bengali.
5. Providing written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Not providing with written informed consent of participation.
2. Patients who are too sick for consultation, unable to read patient information sheet, unwilling to take part or not giving consent to join the study.
3. Vulnerable population- Unconscious, ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, institutionalized subjects, and mentally incompetent people.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
5. Pregnant and puerperal women, lactating mothers
6. Patient under tobacco chewing and/or smoking, betel leaf and/or alcoholism and/or any other form(s) of substance abuse and/or dependence
7. Self-reported immune-compromised state
8. Already undergoing homoeopathic treatment for chronic disease within last 6 months. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bleeding On Marginal Probing (BOMP) index |
At baseline, after 1 month and 2 months of
intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gingival Index (GI) score |
At baseline, after 1 month and 2 months of
intervention |
Measure Yourself Medical Outcome Profile v2
(MYMOP-2) questionnaire |
At baseline, after 1 month and 2 months of
intervention |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
09/09/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsujan4730@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Gingivitis is an inflammatory condition of the gums caused by bacterial infection, affecting only the soft tissues without loss of attachment or migration of the junctional epitheliumāunlike periodontitis. The use of homoeopathic medicines is extensive globally to treat the condition; research evidences in favor of homoeopathy are not well marked. So, we intend to undertake the research to evaluate the efficacy of homoeopathic medicines in the treatment of gingivitis. This double-blind, randomized, placebo-controlled trial on 114 patients suffering from gingivitis intends to ascertain the probable significant treatment effect after using of Individualized Homoeopathic Medicine. Assessment will be done by Bleeding On Marginal Probing (BOMP) Index [Primary outcome], Gingival Index (GI) and The Measure Yourself Medical Outcome Profile-2 (MYMOP-2) [Secondary outcome], to be measured at baseline and every month, up to 2 months. Treatment effect assessment is done by verum vs placebo analysis. |