| CTRI Number |
CTRI/2023/04/052082 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Oleander in contact dermatitis
|
|
Scientific Title of Study
|
Effectiveness of Nerium Oleander in contact dermatitis: A single arm clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanak Kumar |
| Designation |
Associate Professor,Department of practice of medicine |
| Affiliation |
RBTS Govt Homoeopathic medical college and hospital |
| Address |
RBTS Govt Homoeopathic medical college and hospital
Ramdyalunagar,Muzaffarpur
Department of Practice of medicine
Muzaffarpur
BIHAR
842002
India |
| Phone |
7903631714 |
| Fax |
|
| Email |
drkanak92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanak Kumar |
| Designation |
Associate Professor,Department of practice of medicine |
| Affiliation |
RBTS Govt Homoeopathic medical college and hospital |
| Address |
RBTS Govt Homoeopathic medical college and hospital
Ramdyalunagar
Outpatient department 1 and 5
Muzaffarpur
BIHAR
842002
India |
| Phone |
7903631714 |
| Fax |
|
| Email |
drkanak92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanak Kumar |
| Designation |
Associate Professor,Department of practice of medicine |
| Affiliation |
RBTS Govt Homoeopathic medical college and hospital |
| Address |
RBTS Govt Homoeopathic medical college and hospital
Ramdyalunagar
Out patient department 1 and 5
Muzaffarpur
BIHAR
842002
India |
| Phone |
7903631714 |
| Fax |
|
| Email |
drkanak92@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Govt Homoeopathic medical college and Hospital,Ramdyalunagar,Muzaffarpur |
|
|
Primary Sponsor
|
| Name |
RBTS Govt Homoeopathic medical college and hospital |
| Address |
RBTS Govt Homoeopathic medical college and hospital
Ramdyalunagar Muzaffarpur |
| 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 Kanak Kumar |
RBTS Govt Homoeopathic Medical College and Hospital |
Out patient department 1and 5
Muzaffarpur
BIHAR |
7903631714
drkanak92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L239||Allergic contact dermatitis, unspecified cause, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nerium Oleander |
Homoeopathic drugs as detailed in the Homoeopathic Pharmacopoeia (India/US) will be used in the study on the basis of symptom similarity (Homoeopathic principle). The drugs identified for the trial shall be procured from a GMP compliant pharmaceutical firm. Medicines will be dispensed in sugar globules of standard size 30.Homoeopathic medicines in centesimal potencies in required doses shall be prescribed to be taken orally. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 18-60 years
2.Self-reported & pre-diagnosed cases of Contact dermatitis.
3.Patients with symptomatology of contact dermatitis.
4.Both sexes.
|
|
| ExclusionCriteria |
| Details |
1.Patients or, its guardian unwilling to take part or not giving consent to join the study.
2.Diagnosed cases of systemic diseases, psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
3.Substance abuse and/ or dependence.
4.Self-reported immune-compromised state.
5.Undergoing homoeopathic treatment for any chronic disease within the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The response and improvement of the patient were observed in cases of contact dermatitis through marked improvement on boils and eruption in the patient |
0 to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessed by Contact Dermatitis Quality of life Index (CDQL) |
0 to 3 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/05/2023 |
| Date of Study Completion (India) |
16/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Contact dermatitis is an itchy rash caused by direct contact with a substance or an allergic reaction to it might result in the itchy rash condition known as contact dermatitis. Contact dermatitis can cause significant impairment in the patient’s overall quality of life. The disease requires treatment attention due to its rising frequency and risk of progression. With this intention, we plan to test the effectiveness of Nerium Oleander in contact dermatitis. |