| CTRI Number |
CTRI/2025/09/095072 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how a homoeopathic medicine bacillus morgan pure works in treating dermatitis |
|
Scientific Title of Study
|
An Interventional Study To Assess The Effectiveness Of Bacillus Morgan Pure In Case Of Dermatitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Singh |
| Designation |
PG Scholar |
| Affiliation |
Homoeopathy University |
| Address |
Department of Materia Medica OPD No 4 Dr MPK Homeopathic Medical College Hospital and Research Centre
A Constituent College of Homoeopathy University Sanganer Saipura Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
8209401013 |
| Fax |
|
| Email |
prisha16divya14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Tuteja |
| Designation |
Professor |
| Affiliation |
Homeopathy University |
| Address |
Department of Materia Medica OPD No 4 Dr MPK Homeopathic Medical College Hospital and Research Centre
A Constituent College of Homoeopathy University Sanganer Saipura Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
soniatuteja860@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Tuteja |
| Designation |
Professor |
| Affiliation |
Homeopathy University |
| Address |
Department of Materia Medica OPD No 4 Dr MPK Homeopathic Medical College Hospital and Research Centre
A Constituent College of Homoeopathy University Sanganer Saipura Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
soniatuteja860@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra pal homoeopathic hospital and research centre collegiate hospital of Dr M.P. khuteta homoeopathic medical College, hospital and research centre plot no 10,11,12 Hahnemann marg , diggi-malpura road , homeopathy University campus, saipura , Sanganer, Jaipur,302029 rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathy Medical College Hospital and Research Centre |
| Address |
10 11 12 Ward no 36 Saipura Sanganer Jaipur 302029 |
| 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 Divya Singh |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department of Materia Medica OPD No 4 Dr MPK Homeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University 10 11 12 Ward no 36 Saipura Sanganer Jaipur 302029
Jaipur
RAJASTHAN |
8209401013
prisha16divya14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homoeopathy University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L20-L30||Dermatitis and eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus Morgan Pure |
Bacillus Morgan Pure shall be given orally in potency of 30C and 200C as per the case and Hahnemannian guidelines in the form of globules of 40 number, dose and repetition as per need of the case reassessment at the end of 6 month |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to give consent and willing to take Homeopathic Treatment and follow up regularly
The medicine is given to those patients who have symptoms similar to Bacillus Morgan Pure , i.e burning, itching, scalding, redness, heat, fissures, dryness oozing, eruptions , generally aggravate by heat, washing, at night |
|
| ExclusionCriteria |
| Details |
Cases with multi systemic illness will be excluded from the study and cases with advanced pathology
Pregnant women and lactating mothers
Immuno Compromised patients such as those sufferings from HIV, Hepatitis-B ,C etc.
Patients who are not willing to give consent and taking other treatments for Dermatitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to scores obtained (pre and post treatment ) from Dermatology Life Quality Index (DLQI) . |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bacillus Morgan Pure selected will be effective in managing the cases of Dermatitis. It is expected that Bacillus Morgan Pure will improve the frequency and intensity of Dermatitis and improve quality of life of patient. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
02/10/2025 |
| 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
|
This study is prospective, uncontrolled, open label, single arm , unicentric, experimental, clinical study to assess the effectiveness of bowel nosode Bacillus morgan pure in cases of Dermatitis. This study will evaluate the extent of improvement in dermatitis cases using DLQI scale. The primary outcome will be according to the scores obtained (pre and post treatment)from DLQI scale. Null hypothesis - There is no significant improvement assessed through pre and post DLQI score in the management of dermatitis by prescribing homoeopathic bowel nosode BACILLUS MORGAN PURE
Alternate hypothesis - There is a significant improvement assessed through pre and post DLQI score in the management of dermatitis by prescribing homoeopathic bowel nosode BACILLUS MORGAN PURE |