| CTRI Number |
CTRI/2025/02/080554 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Homoeopathic medicines in managing Recurrent Oral ulcers |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicines and Borax 3X in the treatment of Recurrent Oral Aphthae An open label randomized clinical trial |
| 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 Gauthami Nayak |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy Kolkata |
| Address |
OPD 18 Department of Homoeopathic Materia Medica National Institute of Homoeopathy GE Block Sector III Salt Lake Kolkata 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
7090130762 |
| Fax |
|
| Email |
gauthami.nayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanta Rath |
| Designation |
Professor Community Medicine |
| Affiliation |
National Institute of Homoeopathy Kolkata |
| Address |
OPD 18 Department of Homoeopathic Materia Medica National Institute of Homoeopathy GE Block Sector III Salt Lake Kolkata 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanta Rath |
| Designation |
Professor Community Medicine |
| Affiliation |
National Institute of Homoeopathy Kolkata |
| Address |
OPD 18 Department of Homoeopathic Materia Medica National Institute of Homoeopathy GE Block Sector III Salt Lake Kolkata 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy GE Block Sector III Salt Lake Kolkata 700106 |
|
|
Primary Sponsor
|
| Name |
National Institue of Homoeopathy Kolkata |
| Address |
National Institute of Homoeopathy Block GE Sector III Salt Lake Kolkata 700106 Materi Medica Department OPD 18 |
| 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 Gauthami Nayak |
National Institute of Homoeopathy Kolkata |
OPD 18 Department of Homoeopathic Materia Medica National Institute of Homoeopathy GE Block Sector III Salt Lake Kolkata 700106
Kolkata
WEST BENGAL |
7090130762
gauthami.nayak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of National Institute of Homoeopathy Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K120||Recurrent oral aphthae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Borax 3X |
After screening using the eligibility criteria and obtaining written informed consent participants will be included in the study. According to the Random number table patient will be administered with Borax 3X. It will be repeated as 2 tablets thrice a day for a week. Each enrolled case will be followed up monthly up to 3 months and medicine will be repeated in the same order during every follow up. Outcome data will be assessed through Ulcer Severity Score. |
| Intervention |
Individualized Homoeopathic Medicines |
After screening using the eligibility criteria and obtaining written informed consent participants will be included in the study. According to the Random number table patient will be administered with Individualized Homoeopathic Medicines. Dose and repetition will be decided on the basis of Homoeopathic principles. Each enrolled case will be followed up monthly up to 3 months. Outcome data will be assessed through Ulcer Severity Score. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting with Aphthous ulcer and clinically diagnosed
2 Patients with known but controlled systemic diseases
3 Patients giving written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 Patients with immunocompromised diseases
2 Cases suffering from uncontrolled systemic illness or life-threatening conditions
3 Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Individualized Homoeopathic Medicines in Recurrent Oral Aphthae using the Ulcer Severity Score |
At baseline and third month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the frequently indicated Homoeopathic medicine in Recurrent Oral Aphthae |
At baseline & 3 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="6"
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
|
Recurrent Oral Aphthae is a perplexing condition which causes recurrent painful ulcers in the oral mucosa. This study will be an open label randomized clinical trial to evaluate the effectiveness of Individualized Homoeopathic Medicines and Borax 3X in the treatment of Recurrent Oral Aphthae. The treatment will be assessed using the Ulcer Severity Score. Patients who suffering from recurrent oral aphthae and registered in the OPD and IPD of National Institiute of Homoeopathy Kolkata and who are fulfilling the inclusion and exclusion criteria will be recruited in the study. A random number chart is generated and according to it 50 percentage of patients will receive Individualized Homoeopathic Medicines, and the other 50 percentage will receive Borax 3X. The patients receiving individualized Homoeopathic Medicines, the dose and repetition will be according to the principles of Homoeopathy. The patients receiving Borax 3X, will be given as 2 tablets, thrice a day for a week. the medicine will be repeated in the same manner until the third month. Primary assessment will be done using the Ulcer Severity Score at baseline and third month of treatment. |