| CTRI Number |
CTRI/2025/02/080126 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Psoriasis vulgaris and Homoeopathy |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Intervention to Evaluate the Response in the selective inflammatory biomarkers (CBC, ESR, hS-CRP, IL-6) in Psoriasis vulgaris- Randomized, Double-Blind, Placebo-Controlled Cross-Over Trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dastagiri P |
| Designation |
scientist 2 |
| Affiliation |
Central Council for Research In Homoeopathy |
| Address |
National Homoeopathy Research in Mental Health
Dept of practice of Medicine
Dermatology OPD
Sachivothamapuram
Kurichy
Kottayam
National Homoeopathy Research in Mental Health
Dept of Practice of Medicine
Dermatology OPD
Sachivothamapuram
Kurichy
Kottayam
Kottayam
KERALA
686532
India |
| Phone |
09000444409 |
| Fax |
|
| Email |
drdastagirinhrimh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sitharthan |
| Designation |
Principal |
| Affiliation |
Kerala university of Health Sciences |
| Address |
National Homoeopathy Research in Mental Health
Dept of Practice of Medicine
Sachivothamapuram
Kurichy
Kottayam
National Homoeopathy Research in Mental Health
Dept of Practice of Medicine
Sachivothamapuram
Kurichy
Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthanr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sitharthan.R. |
| Designation |
Principal |
| Affiliation |
Kerala university of Health Sciences |
| Address |
National Homoeopathy Research in Mental Health
Dept of Practice of Medicine
Sachivothamapuram
Kurichy
Kottayam
National Homoeopathy Research in Mental Health
Dept of Practice of Medicine
Sachivothamapuram
Kurichy
Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthanr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Naational Homoeopathy Research Institute in Mental Health, Under Central Council for Research in Homoeopathy, Ministry of AYUSH, Kottayam, Kerala.686532. |
|
|
Primary Sponsor
|
| Name |
National Homoeopathy Research institute in Mental health Kottayam Kerala India |
| Address |
National Homoeopathy Research in Mental Health
Under Central Council for Research in Homoeopathy
Ministry of AYSUH
Kurichy
Kottayam, 686532.
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dastagiri |
National Homoeopathy Research Institute in Mental Health |
National Homoeopathy Research in Mental Health
Dept of Practice of Medicine
Deramatology OPD
Under Central Council for Research in Homoeopathy
Ministry of AYSUH
Kurichy
Kottayam
India
Kottayam
KERALA |
9000444409
drdastagirinhrimh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHRIMH INSTITUTIONAL ETHICAL COMMITTEE |
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 |
| Intervention |
Individualized Homoeopathic medicines will be remedies that will be prescribed and administered orally in centesimal potencies (6c, 30c, 200c, 1M, 10M, and 50M) with necessary repetition per the homeopathic principles of posology for one year.
|
Individualized homeopathic medicines will be remedies that will be prescribed and administered orally in centesimal potencies (6c, 30c, 200c, 1M, 10M, and 50M) with necessary repetition per the homeopathic principles of posology for one year. |
| Comparator Agent |
Placebo |
A placebo should be identical to
Homoeopathic medicine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18- 60 years, all genders.
Clinically diagnosed with a mild, moderate case of psoriasis vulgaris ( according to the classification of psoriasis severity) with increased IL-6biomarker. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers
Severe form of psoriasis vulgaris ( according to the classification of psoriasis Severity )
Cases with psoriatic arthritis.
Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
Participants are on systemic immune-suppressive therapy or any treatment below six months.
The patient has generalized pustular Psoriasis or erythrodermic Psoriasis with Significant functional impairment and high levels of distress. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the IL-6 inflammatory biomarkers baseline after the 6th month and at the 12th month after the intervention in both the verum and placebo groups |
Changes in the IL-6 inflammatory biomarkers baseline after the 6th month and at the 12th month after the intervention in both the the verum and placebo groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the PASI score before and after treatment before and after intervention in both verum and placebo groups |
Baselin,Every 3, 6, 9 and 12 months |
| Changes in the Dermatology Life Quality Index (DLQI) score before and after intervention in both verum and placebo groups |
Baseline, Every 3,6,9 and 12 months |
| Outcome related to impact in daily living (ORIDL) score after intervention in both verum and placebo groups |
Every 3,6,9 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
03/03/2025 |
| 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="2"
Months="0"
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
|
Psoriasis is a chronic, non-communicable, painful, disfiguring, and disabling disease for which there is no cure and with a tremendous negative impact on a patient’s quality of life (QoL). It can occur at any age and is most common in 50–69. The prevalence of this disease reported in countries ranges between 0.09% and 11.4%, making psoriasis a severe global problem. The inflammatory nature of this disease was demonstrated by a systemic and dermal secretion of cytokines such as interleukins (IL.): IL-2, 6, 8, 12,17,18, 22, 23, 24, interferon-γ, (INF- γ) and Tumour Necrosis Factor- α (TNF- α). In addition, the IL-6 secretion induced by TNF- α leads to hepatic stimulation of the production of acute-phase reactants such as c-reactive protein (CRP) and fibrinogen. CRP is an acute-phase protein that indirectly illustrates the pro-inflammatory activity of cytokines, so it is considered an inflammatory marker and is higher in psoriasis patients than in control groups (non-psoriatic patients), along with ESR Levels. However, there are gaps concerning psoriasis and changes in the underlying inflammatory markers through individualized homoeopathic intervention. Hence, this study aims to change the inflammatory markers (via CBC, ESR, hs-CRP, IL-6) in response to Individualized homoeopathic intervention in psoriasis vulgaris and the relation of PASI score with the biomarkers. |