| CTRI Number |
CTRI/2025/08/093355 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing The Effectiveness Of Individualized Homoeopathic Medicines Vs Chrysarobinum In The Treatment Of Dermatophytosis |
|
Scientific Title of Study
|
To Evaluate The Effectiveness Of Individualized Homoeopathic Medicines Vs Chrysarobinum For The Treatment Of Dermatophytosis: A Randomized Controlled 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 Aishwarya Shukla |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre |
| Address |
Department Of Homoeopathic Materia Medica Third Floor
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre Nanakpura Motibagh New Delhi
South West
DELHI
110021
India |
| Phone |
9958332943 |
| Fax |
|
| Email |
draishwaryashukla2604@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Rajeev Nair |
| Designation |
Professor & HOD, Department of Homoeopathic Materia Medica |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre |
| Address |
Department Of Homoeopathic Materia Medica Third Floor
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre Nanakpura Motibagh New Delhi
South West
DELHI
110021
India |
| Phone |
7994273285 |
| Fax |
|
| Email |
drrajivh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Shukla |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College, Hospital And Research Centre |
| Address |
Department Of Homoeopathic Materia Medica Third Floor
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre Nanakpura Motibagh New Delhi
South West
DELHI
110021
India |
| Phone |
9958332943 |
| Fax |
|
| Email |
draishwaryashukla2604@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Homoeopathic Materia Medica Third Floor
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre Nanakpura Motibagh New Delhi 110021 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Shukla |
| Address |
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre Nanakpura Motibagh New Delhi 110021, India |
| 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 Aishwarya Shukla |
Dr B R Sur Homoeopathic Medical College Hospital And Research Centre |
OPD And IPD, Dr B R Sur Homoeopathic Medical College Hospital And Research Centre Nanakpura Motibagh New Delhi 110021, India
South West
DELHI |
9958332943
draishwaryashukla2604@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B35||Dermatophytosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chrysarobinum |
Chrysarobinum will be administered in centesimal
potencies, selected according to homoeopathic principles. The dose and repetition will be done as per the requirement of each case. The route of
administration will be Oral, in globules form. Duration: 6
months. |
| Intervention |
Individualized Homoeopathic
Medicines |
Individualized Homoeopathic
Medicines will be administered in centesimal potencies,
selected according to
homoeopathic principles. The
dose and repetition will be done as per the requirement of each case. The route of
administration will be Oral, in globules form. Duration: 6
months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from Dermatophytosis based on clinical presentation of lesions.
Desirable – evidence of presence of fungal hyphae, spores on microscopic examination on KOH wet
mount.
2. Both sexes of age group 18 years to 65 years.
3. Not using any systemic/ topical antifungal treatment for past 2 weeks.
4. Patient who are willing for regular follow-ups. |
|
| ExclusionCriteria |
| Details |
1. Dermatophytosis patients suffering from any life-threatening illness who are terminally ill, under immuno-suppressive treatment or self-reported immuno-compromised state.
2. Patients of malignancy or too sick for consultation.
3. Diagnosed case of mental illness / psychiatric/ other uncontrolled/ life threatening conditions.
4. Patients taking any other mode of treatment.
5. Pregnant and lactating mothers.
6. Substance abuse and or dependence |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study is expected to yield better therapeutic results with Individualized homoeopathic
medicines as compared to Chrysarobinum in treatment of dermatophytosis. |
1 year (12 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. This study anticipates improvements in itching severity and quality of life among patients receiving homoeopathic medicines as reflected by improved scores on the Peak Pruritus
Numeric Rating Scale and the Dermatology Life Quality Index (DLQI).
2. A reduction or clearance of fungal elements is expected to be observed on potassium hydroxide (KOH) microscopic examination following homoeopathic treatment.
3. The study is expected to highlight a subset of individualized homoeopathic medicines that are
more frequently prescribed and associated with positive clinical outcomes in the management
of dermatophytosis.
4. The study is expected to outline the clinical indications of Chrysarobinum- demonstrating its
clinical effectiveness in treating dermatophytosis. |
1 year (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)
|
01/09/2025 |
| 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 compares the effectiveness of Individualized Homeopathic Medicines and Chrysarobinum in treating patients with Dermatophytosis, aged 18-60 years. Patients will be randomly assigned to receive either Individualized homeopathic medicines or Chrysarobinum. The study will measure the improvement by clinical assessment of the lesion with photographic evidence, Peak Pruritus Numeric Rating Scale (PP-NRS), Dermatological Life Quality Index scores and by observing changes in fungal load on potassium hydroxide (KOH) microscopic examination. The primary goal is to compare the efficacy of these two approaches in managing Dermatophytosis, improving quality of life, and reducing disease severity. The results will provide valuable insights into the effectiveness of Homeopathic approaches in treating Dermatophytosis. |