Health Condition 1: F200- Paranoid schizophrenia
Conditions
Interventions
None listed
Sponsors
Ministry of AYUSH, Government of India
Eligibility
Inclusion criteria
Inclusion criteria: Schizophrenia Subjects will be diagnosed based on Diagnostic criteria of Schizophrenia according to DSM-5 as well as Ayurvedic Diagnosis of Unmada. Patients with treatment resistance symptoms and predominantly having cognitive symptoms with stable medications for at least 1 month will be recruited. Inclusion criteria 1. Diagnosed patients of Unmada according to Ayurveda and Patients of Schizophrenia spectrum disorders as per DSM-5. 2. Schizophrenia patients on treatment with antipsychotics (except clozapine) and on stable medication for at least six weeks 3. Persistence of moderate or greater severity of positive or negative symptoms as assessed with SAPS and SANS ( ââ?°Â¥ 3 severity of SAPS (Item numbers 7, 20, 25, 34) and SANS (Item numbers (7, 13, 17, 22). 4. Subjects between 18 years and 45 years of age. 5. Patients who are on stable medications at least for a month. Healthy Controls Inclusion criteria 1. Age range: 18 ââ?¬â?? 45 years 2. Both sexes 3. Ready to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Schizophrenia Exclusion criteria 1. Patients with psychosis other than schizophrenia, neurotic disorders like anxiety, OCD, substance use disorders, major systemic illness, neurological disorders and immune system disorders 2. Patients treated with any antibiotics or Probiotic/Prebiotic agents in the previous month; 3. Patients with suicidal tendencies 4. Pregnant and lactating mothers 5. Patients Unsuitable (Subjects suffering from Diarrhea, rectal bleeding, hematuria, vaginal bleeding, flatulence, acute fever, acute rhinitis, any injury to rectum, children, pregnant women, Low/High BMI, subjects undergoing Basti therapy.) for Virechana procedure. 6. Patients with uncontrolled Diabetes mellitus, Hypertension, severe Hepatic Renal and Pulmonary Dysfunction. Healthy Controls Exclusion criteria 1. Diagnosis of any psychiatric or neurological disorder 2. Family history of psychiatric or neurological disorder in any of the first-degree relatives 3. Any immune disorder or medical disorder interfering with the research. 4. Patients treated with any antibiotics or Probiotic/Prebiotic agents in the previous month;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OUTCOME MEASURES ââ?¬Â¢ The changes in Vagal tone using HRV & Electrogastrography in subjects diagnosed with Schizophrenia, before & after Virechana karma. ââ?¬Â¢ The changes in gut microbiota in subjects diagnosed with Schizophrenia before & after Virechana karma.Timepoint: Before Deepana Pachana (T0), before Virechana (T1), and after Virechana Karma (T2).. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The changes in Liver Function Test, Lipid profile and Sr. Electrolytes, before & after Virechana karma. 2. The changes in ââ?¬Â¢ BPRS, CGI, SANS & SAPS ââ?¬â?? for Patients diagnosed with Schizophrenia before & after Virechana karma. ââ?¬Â¢ GSRS- Gastrointestinal Symptom Rating Scale ââ?¬Â¢ WHO-QOL (Brief) & ââ?¬Â¢ Perceived Stress scaleTimepoint: Before Deepana Pachana (T0), and after Virechana Karma (T2). | — |
Countries
India
Contacts
Public ContactDr Kishore Kumar R
NIMHANS
Outcome results
None listed