| CTRI Number |
CTRI/2025/02/079898 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness Of Homoeopathic Medicines in Gingivitis |
|
Scientific Title of Study
|
Clinical utility of individualized homoeopathic medicine in Gingivitis: A prospective clinical study |
| 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 Abu Amaan Siddiqui |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony
South
DELHI
110024
India |
| Phone |
8439194804 |
| Fax |
|
| Email |
amaan.siddiqui1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Rai |
| Designation |
Professor/ Principal |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony
South
DELHI
110024
India |
| Phone |
8076105535 |
| Fax |
|
| Email |
principalnhmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Abu Amaan Siddiqui |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony
South
DELHI
110024
India |
| Phone |
8439194804 |
| Fax |
|
| Email |
amaan.siddiqui1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out-Patient Department of Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi, India, 110024 |
|
|
Primary Sponsor
|
| Name |
Dr Abu Amaan Siddiqui |
| Address |
Department of Materia Medica, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi, India, 110024 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Abu Amaan Siddiqui |
Nehru Homoeopathic Medical College and Hospital |
Dental OPD No. 01, Ground Floor, Hospital Block, Nehru Homoeopathic Medical College and Hospital, B-Block, Defence Colony, New Delhi, India, 110024
South
DELHI |
8439194804
amaan.siddiqui1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, (2) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Intervention- Individualized Homoeopathic Medicine intervention to be conducted on patients suffering from Gingivitis. A complete detailed case taking, analysis, evaluation, and repertorisation will be done according to the homoeopathic principles and then the final individualized homoeopathic medicine will be given.
Mode of administration will be oral.
Dose, Frequency, Repetition: Depending upon severity of symptoms, susceptibility of the patient according to homoeopathic principles.
Total Duration of Intervention- Each case will be given Individualized Homoeopathic Medicine for 2 months.
Follow up: Follow up of cases will be done every 2 weeks till 2 months and also depending upon the severity of the symptoms, and as per the need and the necessity of the case. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(a) Patient of age between 18 - 60 years of both sex
(b) Patient having clinical signs and symptoms of gingivitis
(c) Patient having Mean Gingival Index Score ≥ 1 (moderate and severe inflammation)
(d) Patient giving informed consent for homeopathic treatment |
|
| ExclusionCriteria |
| Details |
(a) Age under 18 and more than 60;
(b) Antibiotic use 2 weeks prior to the study
(c) Pregnant and lactating women
(d) Pre-diagnosed health conditions and/or routine medications that would affect bone/soft tissue healing (uncontrolled diabetes, blood disorders, intravenous bisphosphonates etc.)
(e) Self-reported immune compromised state (ex- HIV, Hepatitis B)
(f) Smoking
(g) Patients who are already enrolled in some other study.
(h) Patients who are not willing to give the consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival Index |
Every 2 Weeks till 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Papillary Bleeding Index |
Every 2 Weeks till 2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/02/2025 |
| 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
|
Gingivitis is the inflammatory condition of gingival tissues, commonly caused by bacterial infections. The purpose of this study is to evaluate the effectiveness of individualized homeopathic medicines in treating gingivitis. Primary objective of this study is to evaluate the effectiveness of individualized homoeopathic treatment in patients with gingivitis. The Secondary objective of this study are to measure change in Gingival Index (GI) and Modified Papillary Bleeding Index (MBPI) after treatment with individualized homoeopathic medicines and to identify useful homeopathic medicines with their indications. The duration of study will be for one year and each patient will be studied for 2 months period at Dental Outdoor Patient Department (OPD) of Nehru Homoeopathic Medical College and Hospital, New Delhi. Each individual case will be assessed according to Gingival Index (GI) and Modified Papillary Bleeding Index (MPBI) in patients of gingivitis at baseline, and at interval of 2 weeks till 2 months.A complete detailed case taking, analysis, evaluation and individualisation of case and repertorisation will be done according to the homoeopathic principles and then the final selection of medicine will be done after consulting standard Homoeopathic Materia Medica. Medicine will be prescribed following strict Homoeopathic principles. After the completion of study, the result will be analysed and represented by using different statistical methods. |