| CTRI Number |
CTRI/2024/05/067875 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Ringworm by Homeopathic Medicine Chrysarobinum |
|
Scientific Title of Study
|
Effectiveness of Chrysarobinum in the treatment of Tinea Corporis |
| 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 Surendra Kumar Shrivastava |
| Designation |
Associate Professor |
| Affiliation |
R.B.T.S. Govt. Homeopathic Medical College And Hospital |
| Address |
Dept. of Organon of Medicine
Academic Block
R.B.T.S. Govt. Homeopathic Medical College And Hospital
Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
9470468526 |
| Fax |
|
| Email |
drsurendrarbts@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riya Sah |
| Designation |
Pg Scholar |
| Affiliation |
R.B.T.S. Govt. Homeopathic Medical College And Hospital |
| Address |
Dept. of Organon of Medicine
Academic Block
R.B.T.S. Govt. Homeopathic Medical College And Hospital Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
9262936770 |
| Fax |
|
| Email |
riyasah4848@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar |
| Designation |
Pg Scholar |
| Affiliation |
R.B.T.S. Govt. Homeopathic Medical College And Hospital |
| Address |
Dept. of Organon of Medicine
Academic Block
R.B.T.S. Govt. Homeopathic Medical College And Hospital Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
9608479983 |
| Fax |
|
| Email |
praveen9386@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.B.T.S. Govt. Homeopathic Medical College And Hospital Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
R.B.T.S. Govt. Homoeopathic Medical College And Hospital Muzaffarpur Bihar |
| Address |
Ramdayalu Nagar Muzaffarpur Bihar Postal code 842002 |
| 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 Riya Sah |
R.B.T.S. Govt. Homoeopathic Medical College And Hospital |
Hospital Building OPD 1 (Dept. of Medicine), OPD 6 (Dept. of Skin)
Muzaffarpur
BIHAR |
9262936770
riyasah4848@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RBTS Govt. Homoeopathic Medical College And Hospital- IEC |
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 |
Chrysarobinum |
chrysarobinum medicine given orally to the patient who is suffering from tinea Corporis in 30C or 200C Potency. Dose of medicine is selected according to susceptibility of patient. the patient was called for follow-up every 15 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 15 years to 25 years will be included. Patients with symptomatology of Tinea Corporis. The symptoms of patients which will be come under ICD 10 B35.4. Both sexes. Patients volunteering. |
|
| ExclusionCriteria |
| Details |
Patient of age above 25 years and below 15 years. Who don’t follow ICD 10 B35.4 symptoms.Patients unwilling to take part or not giving consent to join the study. Diagnosed cases of systemic diseases, psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure. Substance abuse and/ or dependence. Self-reported immune-compromised state.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chrysarobinum homoeopathic medicine when prepared and administered according to homoeopathic principles must be helpful in treating Tinea Corporis and hence arresting the progress of the disease. |
1-2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This will help to develop future affordable recommendations in place of expensive external treatments. |
1-2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Tinea corporis is the
most common dermatophytosis. It also known as ‘ringworm,’ is a superficial
dermatophyte infection of the skin. Chrysarobinum Homoeopathic Medicine is indicated in case of ring worm. So in cases of Tinea Corporis Chrysarobinum can aid Homoeopaths. |