| CTRI Number |
CTRI/2020/05/025137 [Registered on: 13/05/2020] Trial Registered Prospectively |
| Last Modified On: |
19/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of psoriasis by homoeopathy |
|
Scientific Title of Study
|
An open label observational study to assess the role of homoeopathic similimum in the management of psoriasis |
| Trial Acronym |
PSR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANJU RANI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
STATE NATIONAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, OPD room no. 2, Viraj Khand 1, GOMTI NAGAR, LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8439336136 |
| Fax |
|
| Email |
dr.anjupanwarr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar Vimal |
| Designation |
Professor |
| Affiliation |
State National Homeopathic Medical College and Hospital |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy, Opd Room no. 2, viraj khand 1, Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9532796688 |
| Fax |
|
| Email |
drsmitavimal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANJU RANI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
STATE NATIONAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
STATE NATIONAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL VIRAJ KHAND 1, GOMTI NAGAR, LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8439336136 |
| Fax |
|
| Email |
dr.anjupanwarr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
State National Homoeopathic Medical College and Hospital |
| Address |
VIRAJ KHAND 1 GOMTI NAGAR LUCKNOW 226010 |
| 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 |
| ANJU RANI |
STATE NATIONAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
OPD Room no. 2,Viraj Khand 1 Gomti Nagar Lucknow 226010 Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
8439336136
dr.anjupanwarr@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: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
homoeopathic medicines |
homoeopathic similimum medicines will be given in varying potencies as per need of the case |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed cases of psoriasis
literate patients willing to give consent
|
|
| ExclusionCriteria |
| Details |
patient suffering from other diseases
patients with complications like arthritis or psychiatry disorders
patients not willing to sign consent form
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in PASI SCORE |
15DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in DLQI SCORE |
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet, To Be Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Following
provision of patient information sheet and obtainment of written
consent , preliminary screening using inclusion criteria and exclusion
criteria, eligible patients will be recruited into the trial.
Step
1- Selection of the samples (n=30), fulfilling the inclusion criteria, after
detailed screening eligible participants will be recruited for the trial for
the period of 24 weeks.
Step
2- Proper case taking will be done, according to homoeopathic principle, in a
standard case taking proforma.
Step
3- Collected symptoms are to be analyzed and evaluated according to Kent’s
philosophy of evaluation of symptoms. Miasmatic analysis will also be done
accordingly. Following that Totality of the symptoms will be framed.
Step
4- Symptoms of totality will be converted into rubrics, and repertorization is
to be done with the help of Synthesis 9.1 Repertory.
Step
5- Final selection of medicine to be done on the basis of individualization,
after consultation with MateriaMedica, considering the miasmatic background of
the patient.
Step
6- Potency and dose will be selected according to strict homoeopathic
principle.
Step
7- Subsequent prescription will be generated according to Kent’s 12
observations, second prescription and other relevant homoeopathic principles,
details of follow up will be recorded carefully.
Step 8- Follow
up will be done at an interval of two week (15days) for a period of 24 weeks or
6 months. |