| CTRI Number |
CTRI/2024/12/078743 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for fungal infections of skin in adults |
|
Scientific Title of Study
|
Efficacy of Individualized Bacillinum in the treatment of tinea corporis in adults: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-6909 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Pathology & Microbiology, 12, Gobinda Khatick Road,
Tangra
Kolkata
WEST BENGAL
700046
India
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suman Chandra |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Pathology & Microbiology, 12, Gobinda Khatick Road,
Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9871630660 |
| Fax |
|
| Email |
chandra.suman188@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aritra Roy Chowdhury |
| Designation |
4th BHMS Undergraduate Student |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Pathology and Microbiology, OPD room no. PG3, 12, Gobinda Khatick Road, Tangra, India
Kolkata
WEST BENGAL
700046
India |
| Phone |
6290329793 |
| Fax |
|
| Email |
aritraroychowdhury1@gmail.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College & Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata
700046, West Bengal |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College & 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 |
| Prof Dr Shubhamoy Ghosh |
D. N. De Homoeopathic Medical College and Hospital |
Skin OPD (room no. 9) and PG3 OPD (Repertory), Dept. of Pathology and Microbiology, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal
Kolkata
WEST BENGAL |
9831034229
shubhamoy67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De Homoeopathic Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillinum 30CH, 200CH, 1000CH, and 10000CH, 4 medicated cane sugar globules, plus concomitant care measures for three months |
Intervention is planned as administering Bacillinum 30CH, 200CH, 1000CH, and 10000CH in individualized dosages, as decided appropriate by the physicians. Each dose will consist of 4 cane sugar globules no. 40, moistened with Bacillinum, to be taken orally on a clean tongue with an empty stomach. The medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive advice on general management, i.e., external application of olive oil or coconut oil depending upon the economic condition twice a day, keeping the area dry, avoiding the use of tight garments, including the synthetic clothes, and washing the infected clothes and bed linen separately in hot water. Dose: Individualized. Frequency: Individualized. Route of administration: Per oral. Duration of therapy: 3 months |
| Comparator Agent |
Identical-looking placebo, plus concomitant care measures for three months |
Intervention is planned as administering an identical-looking placebo in individualized dosages, as decided appropriate by the physicians. Each dose will consist of 4 cane sugar globules no. 40, moistened with rectified spirit, to be taken orally on a clean tongue with an empty stomach. The sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive advice on general management, i.e., external application of olive oil or coconut oil depending upon the economic condition twice a day, keeping the area dry, avoiding the use of tight garments, including the synthetic clothes, and washing the infected clothes and bed linen separately in hot water. Dose: Individualized. Frequency: Individualized. Route of administration: Per oral. Duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from tinea corporis for 3 months or more, diagnosis confirmed through KOH mount test
2. Age between 18 and 65 years
3. Patients of either sex
4. Ability to understand English and/or Bengali
5. Providing written informed consent
6. Patients using topical agents for tinea lesions will be included after a washout period of two weeks
7. Matching symptomatology of Bacillinum |
|
| ExclusionCriteria |
| Details |
1. Cases with complications like lichenification and eczematisation
2. Similar-looking skin conditions, e.g., seborrheic dermatitis, pityriasis rosea, and psoriasis
3. Patients who are too sick for consultation, unable to read patient information sheets, unwilling to take part, or not giving consent to join the study
4. Vulnerable populations: unconscious, ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people
5. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure
6. Pregnant and puerperal women, lactating mothers
7. Patients with the habit of tobacco chewing and/or smoking, alcoholism, and/or any other form(s) of substance abuse and/or dependence
8. Self-reported immunocompromised state
9. Simultaneous participation in any other clinical trial |
|
|
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 |
| 0 to 10 numeric rating scale (NRS), measuring intensity of itching |
day 0, 1st month, 2nd month, 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Skindex-29 questionnaire |
day 0, 1st month, 2nd month, 3rd month |
| Dermatological Life Quality Index (DLQI) questionnaire |
day 0, 1st month, 2nd month, 3rd month |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/01/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [shubhamoy67@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
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
|
Dermatophyte infections are superficial fungal infections of the skin, hair, and nails. Commonly known as ringworm, these infections are caused by species of the genera Trichophyton, Microsporum, and Epidermophyton. The prevalence of superficial mycotic infection worldwide is 20-25%, of which dermatophytes are the most common agents. T. mentagrophytes surprisingly turned out to be the most common dermatophyte with a prevalence of up to 75.9 to 77.5%, followed by T. rubrum but sometimes also by another Trichophyton. In India, there has been an increase in the prevalence of chronic and recurrent dermatophytosis over the last 4–5 years. This 3-month, double-blind, randomized (2:1), placebo-controlled, parallel-group, phase II/III efficacy trial will be the first attempt to explore the effects of individualized Bacillinum in centesimal potencies against placebo in itching intensity of tinea corporis using the Pruritus intensity score (numeric rating score—NRS). Intervention is planned as administering Bacillinum 30CH, 200CH, 1000CH, and 10000CH in individualized dosages, as decided appropriate by the physicians. Each dose will consist of 4 cane sugar globules no. 40, moistened with Bacillinum, to be taken orally on a clean tongue with an empty stomach. The medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Group differences will be examined in the end. Reports will be published in scientific journals. |