| CTRI Number |
CTRI/2025/09/094859 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Homoeopathic medicine and Kalium arsenicosum in the treatment of Psoriasis. |
|
Scientific Title of Study
|
A Randomized Clinical Study comparing Kalium arsenicosum versus Individualised Homoeopathic Management of Psoriasis among 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 Anjali Kumari |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no B 17 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital plot no 36 B Knowledge Park phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9868248841 |
| Fax |
|
| Email |
anjalikumari01091997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Goel |
| Designation |
Guide & Assistant Professor of Practice of Medicine |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no B 16 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital plot no 36 B Knowledge Park phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9899629129 |
| Fax |
|
| Email |
dr.goel2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Mathur |
| Designation |
Head of Department of Practice of Medicine |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no B 16 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital plot no 36 B Knowledge Park phase 1 greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
Room no G22
Principal office
Ground floor
Plot no 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G22
Principal office
Ground floor
Plot no 36 B Knowledge Park phase 1 Greater Noida Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Kumari |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department
Medicine
Room No 1
Ground Floor
Plot No 36 B Knowledge Park Phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9868248841
anjalikumari01091997@gmail.com |
| Dr Anjali Kumari |
Dr D P Rastogi Central Research Institute of Homoeopathy |
General Out Patient Department
Room No 109
Ground Floor Opposite HCL Sector 24 Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9868248841
anjalikumari01091997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L401||Generalized pustular psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualised Homoeopathic Medicine |
Pill form of administration
Oral route of administration
30 Pill size
In Centesimal scale
First dose after case taking Repetition of dose according to follow up every 4 weeks for 24 weeks. |
| Intervention |
Kalium arsenicosum |
Pill form of administration
Oral route of administration
30 Pill size
In Centesimal scale
First dose after case taking Repetition of dose according to follow up every 4 weeks for 24 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Psoriasis
Age group 18 to 59 years irrespective of gender
Participants willing to give consent for the study
|
|
| ExclusionCriteria |
| Details |
Cases taking treatment of other Chronic Diseases other Autoimmune Disease and other Immunocompromised conditions
Participants undergoing active Conventional treatment for Psoriasis
Participants using any local application for relief
Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the effect of Kalium arsenicosum and Individualised Homoeopathic Management of Psoriasis using Psoriasis Area and Severity Index Score |
Total 16 months
Enrollment period 6 months
Follow up 6 months
Assessment and data analysis 2 months
Report writing 2 months
Statistical analysis to be done at Baseline 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing patient adherence between the two treatment groups |
Total 16 months
Enrollment period 6 months
Follow up 6 months
Assessment and data analysis 2 months
Report writing 2 months
Statistical analysis to be done at Baseline 3 month and 6 month |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
26/09/2025 |
| 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="4"
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
|
This study aims to compare Kalium arsenicosum and Individualised Homoeopathic Management of Psoriasis using Psoriasis Area and Severity Index in which total 68 cases will be enrolled irrespective of gender with 34 cases in each group and outcome will be assessed statistically with repeated ANOVA at baseline 3 month and 6 month and t test would be assessed at baseline and 6 month |