The effectiveness of Siddha and Allopathic treatment as reported by clinicians and patients

Not yet recruiting

Conditions: Psoriasis vulgaris,

Registration Number: CTRI/2020/01/022884

Lead Sponsor: Melaka Manipal Medical College

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 192

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients reaching PASI 75 (75% improvement in the PASI score)	0,1,2,3,4 months

Secondary Outcome Measures

Name	Time	Method
Number of relapses in each patient	Number of patients with different grades of remission

Trial Locations

Locations (1): Department of Dermatology, Venereology and Leprosy and Division of Siddha
🇮🇳
Udupi, KARNATAKA, India
Department of Dermatology, Venereology and Leprosy and Division of Siddha
🇮🇳Udupi, KARNATAKA, India
Dr Arul Amuthan
Principal investigator
9986353238
arul.amuthan@manipal.edu