| CTRI Number |
CTRI/2024/02/062665 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Preventive
Screening |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effectiveness constitutional Homoepathic medicine and Arsenicum album in treating Chronic Plaque Psoriasis. |
|
Scientific Title of Study
|
“Study to assess the effectiveness of constitutional Homoepathic medicines in comparison with Arsenicum album in the treatment of Chronic Plaque Psoriasis in adult age group.“ |
| 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 Veerabhadrappa C |
| Designation |
PhD Scholar Parul University,Gujarat; Professor Dept of Medicine,GHMCH,Bangalore |
| Affiliation |
Parul University of Homoeopathy and Research |
| Address |
Parul University of Homoeopathy and Research
Limda Waghodia Road,Vaghodia, Vadodara district, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9844576674 |
| Fax |
|
| Email |
drveeru9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirtida Desai |
| Designation |
HOD and Professor, Department of Practice of Medicine, Guide - PG and PhD |
| Affiliation |
Parul University |
| Address |
Parul University
Limda Waghodia Road,Vaghodia, Vadodara district, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9574424363 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veerabhadrappa C |
| Designation |
PhD Scholar Parul University,Gujarat; Professor Dept of Medicine,GHMCH,Bangalore |
| Affiliation |
Parul University of Homoeopathy and Research |
| Address |
Parul University of Homoeopathy and Research
Limda Waghodia Road,Vaghodia, Vadodara district, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9844576674 |
| Fax |
|
| Email |
drveeru9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Constitutional Homoeopathic remedy and Arsenucum album for 6months study will be done at Government Homoeopathic Medical College and Hospital,Bangalore. |
|
|
Primary Sponsor
|
| Name |
Dr Veerabhadrappa C |
| Address |
Parul University
Limda Waghodia Road,Vaghodia, Vadodara district, Gujarat. |
| 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 Veerabhadrappa C |
Government Homoeopathic Medical College, Hospital and Research Center |
Dermatology Speciality OPD, Room 51 and 52,Government Homoeopathic Medical College, Hospital and Research Center, Dr, Siddhaiah Puranik Rd, Stage 1, KHB Colony, Basaveshwar Nagar, Bengaluru, Karnataka 560079
Bangalore
KARNATAKA |
9844576674
drveeru9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University, Jawaharlal Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arsenicum album |
Arsenicum album 1M Potency
Dose: One dose for once in Every 15days
Duration for 6 months
Route of administration: Oral |
| Intervention |
Constitutional Homoeopathic Remedy |
Constitutional Homoeopathic Remedy, 1M Potency
Dose:One Dose for once in Every 15 days
Duration of 6 months
Route of Administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged between 20 to 60years.
Both genders.
Patients with clinical presentation of Chronic Plaque Psoriasis.
Those subjects who are willing to take part in the study and sign the written informed consent.
|
|
| ExclusionCriteria |
| Details |
Subjects on prolonged steroidal therapy, phototherapy, systemic therapy for psoriasis.
Subjects having severe complications of psoriasis.
Secondary infected lesions.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the effectiveness of constitutional Homoeopathic medicines in comparison with Arsenicum album in the treatment of Chronic Plaque Psoriasis in adult age group |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To know about Chronic Plaque Psoriasis with respect to its
Definition
Epidemiology
Etiology
Pathogenesis
Clinical Features
Diagnosis |
6 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 2 |
|
Date of First Enrollment (India)
|
22/02/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Chronic Plaque Psoriasis is a common ,chronic, autoimmune, disfiguring, inflammatory and proliferative condition of the skin characterized by silvery white to red colour patches seen over the extensor surfaces. Homoeopathy gives an excellent result in chronic diseases through administration of indicated constitutional remedy. In psoriasis Homoeopathic remedies helps by reducing the severity and area affected and also improving general condition of the patient. |