Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
None listed
Sponsors
Supported under Cetnre of Excellence scheme, Centre for Integrative Medicine and Research (CIMR)
Eligibility
Inclusion criteria
Inclusion criteria: Patients in the age group of 18 to 65 years, regardless of sex. Clinically diagnosed cases of mild to moderate scalp predominant plaque psoriasis defined as PSSI score up to 20 and PASI score up to 10. Patients willing to participate in the study, comply with Medicated Buttermilk Streaming Therapy sessions, and attend follow up visits.
Exclusion criteria
Exclusion criteria: Patients with severe psoriasis, defined as PASI score above 10 and or PSSI score above 20. Patients experiencing acute febrile illness, respiratory tract infections, cough, rhinorrhea, eye infections, etc. Patients with known hypersensitivity or allergy to any ingredients used in MBST such as sesame oil, milk, curd, Sida cordifolia, Cyperus rotundus, and Phyllanthus emblica. Other clinical variants of psoriasis including psoriatic arthritis, pustular psoriasis, guttate psoriasis, and erythrodermic psoriasis. Patients with active scalp infections, wounds, or any other dermatological conditions other than psoriasis affecting the scalp. Patients requiring or receiving systemic therapies such as systemic immunosuppressants, biologic agents, etc. Patients with co morbid conditions such as hypertension with systolic blood pressure above 160 mm Hg and diastolic blood pressure above 100 mm Hg despite anti hypertensive medications, and diabetes mellitus with HbA1c level above 7.0 despite anti diabetic medications. Patients requiring or receiving antineoplastic agents, antibiotics, anti tubercular therapy, or anti retroviral therapy. Patients using antioxidant supplements within the last four weeks. Pregnant and lactating women. Patients requiring emergency medical or surgical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving significant improvement in PSSI in the add-on MBST as compared to patients receiving standard treatment alone.Timepoint: It will be assessed using the Psoriasis Scalp Severity Index (PSSI). At Baseline, 30th day, 60th day, and 90th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving significant improvement in PASI in the add-on MBST as compared to patients receiving standard treatment alone.Timepoint: The Psoriasis Area and Severity Index (PASI) will be assessed at Baseline, 30th day, 60th day, and 90th day.;Proportion of patients achieving significant improvement in Itch NRS in the add-on MBST as compared to patients receiving standard treatment alone.Timepoint: Itching will be assessed using the Itch NRS scale. At Baseline, 30th day, 60th day, and 90th day.;Proportion of patients achieving significant improvement in DLQI in the add-on MBST as compared to patients receiving standard treatment alone.Timepoint: Quality of life will be assessed using the DLQI questionnaire. At Baseline, 30th day, 60th day, and 90th day.;Proportion of patients showing reduction in oxidative stress in the add-on MBST as compared to patients receiving standard treatment alone.Timepoint: Oxidative stress will be assessed using Serum Malondialdehyde (MDA), Total Oxidative Status (TOS), and Oxidative Stress Index (OSI). At Baseline and 60th day.;Proportion of patients showing change in the relative abundance of major bacterial & fungal scalp microbial taxa (phyla, genera, & species) will be compared between the two groups.Timepoint: The Scalp microbiome will be assessed using next-generation sequencing, including 16S rRNA gene sequencing targeting the V3-V4 region for bacterial microbiome & Internal Transcribed Spacer 1 (ITS1) sequencing for fungal microbiome. At Baseline & Day 60.;Proportion of patients showing improvement in metabolic parameters in the add-on MBST as compared to patients receiving standard treatment alone.Timepoint: Metabolic parameters will be assessed using fasting blood glucose, HbA1c, lipid profile (triglycerides, HDL), blood pressure, body mass index, and waist circumference. At Baseline and 90th day. | — |
Countries
India
Contacts
Public ContactDr Gautam Sharma
All India Institute of Medical Sciences
Outcome results
None listed