| CTRI Number |
CTRI/2022/04/042077 [Registered on: 22/04/2022] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic medicines for fungal infection |
|
Scientific Title of Study
|
Repertorial approach of treating tinea corporis using individualised homoeopathic medicines: Double-blind, randomized, placebo-controlled efficacy trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1276-8019 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Maharaj |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College & Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
8777270458 |
| Fax |
|
| Email |
shrutimaharaj7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranil Saha |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College & Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
09836187425 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhranil Saha |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College & Hospital |
| Address |
Dept. of Repertory, 12, Gobinda Khatick Road, Tangra
WEST BENGAL
700046
India |
| Phone |
09836187425 |
| Fax |
|
| Email |
drsubhranilsaha@hotmail.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 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 |
| Dr Shruti Maharaj |
D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal |
Dept. of Repertory, room no. PG-3 OPD and room no. 10 Research OPD, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL |
8777270458
shrutimaharaj7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos |
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 maintained 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 i.e., external application of olive oil/coconut oil depending upon the economic condition twice a day, keeping the area dry, avoiding the use of tight garments including the synthetic clothes, washing the infected clothes and bed linen separately in hot water. Duration of therapy: 3 months. |
| Intervention |
Individualized homeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homeopathic medicines in centesimal potencies. 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. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH and RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. 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 i.e., external application of olive oil/coconut oil depending upon the economic condition twice a day, keeping the area dry, avoiding the use of tight garments including the synthetic clothes, washing the infected clothes and bed linen separately in hot water. 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 (B35.4) for 3 months or more, diagnosis confirmed through KOH mount test
2. Age between 18 and 65 years
3. Patients of either sex
4. Literate patients; ability to read English and/or Bengali
5. Providing written informed consent
6. Patient using topical agents for tinea lesions will be included after a washout period of two weeks |
|
| ExclusionCriteria |
| Details |
1. Cases with complication like lichenification and eczematisation
2. Similar looking skin conditions; e.g., seborrheic dermatitis, pityriasis rosea and psoriasis
3. Vulnerable population – Unconscious, differently abled, terminally or critically ill patients, 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, 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 |
| 5-D pruritus scale |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Skindex-29 questionnaire total and subscale scores |
Baseline, every month, up to 3 months |
| Dermatological life quality index (DLQI) total and subscale scores |
Baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
25/04/2022 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 [shrutimaharaj7@gmail.com].
- For how long will this data be available start date provided 01-11-2023 and end date provided 31-10-2028?
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
|
The prevalence of
superficial mycotic infection worldwide is 20-25% of which dermatophytes are
the most common agents. Homeopathy
peer-reviewed research in tinea infection has remained seriously compromised. A double-blind, randomized, placebo-controlled
trial on 128 participants is attempted at D. N. De Homoeopathic Medical College
and Hospital to identify the differences between individualized homeopathic
medicines and identical-looking placebos in treatment of tinea corporis
after 3 months of intervention. Participants will be randomized into either
verum (n=64) or placebos (n=64) in the mutual context of concomitant care,
e.g., application of olive/coconut oil, maintaining local hygiene, keeping the
area dry, etc. Primary outcome measure is 5-D pruritus scale and secondary
outcome measures are Skindex-29 questionnaire and dermatological life quality
index (DLQI) questionnaire; all to be measured at baseline, and every month, up
to 3 months. Comparative analysis will be carried out to detect group
differences. Results will be published in scientific journals. |