| CTRI Number |
CTRI/2020/01/022884 [Registered on: 20/01/2020] Trial Registered Prospectively |
| Last Modified On: |
14/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
The effectiveness of Siddha and Allopathic treatment as reported by clinicians and patients |
|
Scientific Title of Study
|
Clinical and patient-reported outcomes in patients receiving Siddha standard of care and allopathic standard of care for psoriasis: A prospective cohort study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nayak Deeksha Dayanand |
| Designation |
PhD Research Scholar |
| Affiliation |
Melaka Manipal Medical College (Manipal Campus) |
| Address |
Department of Pharmacology
Melaka Manipal Medical College (Manipal Campus)
Manipal Academy Of Higher education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739061639 |
| Fax |
|
| Email |
nayakdeeksha1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudha Devi |
| Designation |
Professor and Head |
| Affiliation |
Melaka Manipal Medical College (Manipal Campus) |
| Address |
Department of Pharmacology
Melaka Manipal Medical College (Manipal Campus)
Manipal Academy Of Higher education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8971494100 |
| Fax |
|
| Email |
vasudha.devi@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasudha Devi |
| Designation |
Professor and Head |
| Affiliation |
Melaka Manipal Medical College (Manipal Campus) |
| Address |
Department of Pharmacology
Melaka Manipal Medical College (Manipal Campus)
Manipal Academy Of Higher education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8971494100 |
| Fax |
|
| Email |
vasudha.devi@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Melaka Manipal Medical College |
| Address |
Melaka Manipal Medical College (Manipal campus), Madhav nagar, Manipal - 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Arul Amuthan |
Department of Dermatology, Venereology and Leprosy and Division of Siddha |
Kasturba Hospital, Madhav Nagar, Manipal-576104
Udupi
KARNATAKA |
9986353238
arul.amuthan@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional ethics 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with PASI score >10
2.Patient with Psoriasis Vulgaris (plaque psoriasis) and palmoplantar type of psoriasis
3.Patients with no systemic therapy for the past four weeks or topical therapy for the past two weeks |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2.Coexisting eczema or lichen planus
3.Patients on any systemic drugs known to exacerbate psoriasis
4.Patients who are on any other treatment for psoriasis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients reaching PASI 75 (75% improvement in the PASI score) |
0,1,2,3,4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of relapses in each patient
Number of patients with different grades of remission
Time taken to achieve different grades of remission
Duration of remission
Assessment of adverse effects
Improvement in the patient-reported outcomes score |
12 months |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
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)
|
21/01/2020 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective cohort study comparing clinical and patient-reported outcomes in two groups, Siddha standard of care and allopathic standard of care in 192 patients ( 96 patients in each group) with psoriasis. This study has been approved by the Kasturba Medical College and Kasturba Hospital Institutional ethics Committee and patients will be recruited only after taking the informed consent. This will be done in the Department of Dermatology, Venereology and Leprosy, Kasturba Hospital, MAHE, Manipal and Division of Siddha, Center for Integrative Medicine and Research (CIMR), MAHE, Manipal. Patients in both the groups will be observed till 4 months of treatment or till the attainment of PASI 75 and from the fifth month up to 1-year, every month patients will be telephonically followed up. The primary outcome measure will be the number of patients reaching PASI 75. Secondary outcome measures will be the number of relapses in each patient, the number of patients with different grades of remission, time taken to achieve a different grade of remission, duration of remission, assessment of adverse drug reactions, improvement in the patient-reported outcome scores, cost-effectiveness ratio, change in the cytokine levels at the attainment of PASI 75 compared to the baseline level. |