| CTRI Number |
CTRI/2024/05/068223 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of between single dose and multiple doses of individualized homoeopathic medicines in cases ringworm using 50 millesimal potency. |
|
Scientific Title of Study
|
Comparison of efficacy of 50 millesimal scale between single dose and multiple doses of individualized homoeopathic medicines in the treatment of dermatophytosis An open label randomized clinical study
|
| 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 NIKAM ANKITA SHIVAJI |
| Designation |
Post graduatee trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
OPD Number 24, Department of Practice of Medicine
Block GE, Sector 3, Salt Lake
Kolkata 700106
West Bengal
India
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9082516915 |
| Fax |
|
| Email |
ankitanikam23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Pal |
| Designation |
Professor & H.O.D. Dept. Practice of Medicine |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
OPD Number 24, Department of Practice of Medicine
Block GE, Sector 3, Salt Lake
Kolkata 700106
West Bengal
India
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9433902556 |
| Fax |
|
| Email |
drgautampal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NIKAM ANKITA SHIVAJI |
| Designation |
Post graduatee trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
OPD Number 24, Department of Practice of Medicine
Block GE, Sector 3, Salt Lake
Kolkata 700106
West Bengal
India
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9082516915 |
| Fax |
|
| Email |
ankitanikam23@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Homoeopathy Kolkata 700106 India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National institute of homoeopathy OPD number 24 department practice of medicine Block GE sector 3 salt lake kolkata 700106 |
| 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 NIKAM ANKITA SHIVAJI |
National Institute of Homoeopathy |
National Institute of Homoeopathy
OPD Number 24, Department of Practice of Medicine
Block GE, Sector 3, Salt Lake
Kolkata 700106
West Bengal
India
North Twentyfour Parganas
WEST BENGAL |
9082516915
ankitanikam23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B358||Other dermatophytoses, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
50 millesimal scale multiple-dose |
After detail case taking the 50 millesimal scale multiple-dose approach will be given after randomization.
duration of study 18 months. |
| Intervention |
50 millesimal scale single-dose |
After detail case taking the 50 millesimal scale single-dose approach will be given after randomization.
duration of study 18 months. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are clinically diagnosed with dermatophytosis.
Patients of all gender, religion and all socioeconomic status.
Patients 16 years to 70 years.
Patients willing to give written informed consent to be included in study.
|
|
| ExclusionCriteria |
| Details |
Complicated with other skin conditions-psoriasis, eczema, seborrheic dermatitis, pityriasis rosea, impetigo, lichen planus, discoid lupus erythematous, and drug induced skin lesions.
Immune – compromised state.
Diagnosed cases of unstable mental or psychiatric illness and serious systemic disorders or life-threatening infections.
Patient under the treatment of any other therapy for dermatophytosis for last one month.
Patients who are unwilling to for this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy between a single dose and multiple of 50 millesimal scale individualized homeopathic medicines in treatment of dermatophytosis using the dermatological life quality index.
duration of study 18 months and first investigation from baseline after 6 months. |
duration of study 18 months and first investigation from baseline after 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 |
|
Date of First Enrollment (India)
|
12/06/2024 |
| 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
Modification(s)
|
Dermatophytosis is most common and contagious disease in tropical country like India . Despite of non invasiveness of the infection and its difficulty in cure with high expense of treatment pose a serious threat to public health. homoeopathy system of medicine deals with patients holistic healing so much safe and faster result are seen. Many doctors in West Bengal, including Dr. Harimohan Choudhury and Dr. J.N. Kanjilal, were among those who to adopt the 50 millesimal scale first in the treatment of chronic diseases . They employed a single-dose approach, in contrast to the multiple doses suggested by Dr. Hahnemann in the sixth edition of the Organon of Medicine in aphorism 270. objective of study is to compare the efficacy between a single dose and multiple of 50 millesimal scale individualized homeopathic medicines in treatment of dermatophytosis using the dermatological life quality index. patient attending NIH opd and ipd case will be taken , age group 16 to 70 with duration of study of 18 months and patients having comorbid state will be excluded .Patients will be divided into two parallel groups of which 50% patients will receive Individualized homoeopathic medicines in 50 millesimal scale, 1 dose and other 50% will receive Individualized homoeopathic medicines in 50 millesimal scale, but in multiple doses following randomization. Each case will be followed up for six months. First arm: administering individualized homoeopathic medicines in 50 millesimal scale, 1 dose as per the case. Second arm: administering individualized homoeopathic medicines in 50 millesimal scale, multiple doses as per the case. Medicine will be provided from NIH pharmacy .while study any medical emergency will be managed with homoeopathy or if needed then patient will be referred to higher center.
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