Effect of Virechana Karma on vagal tone, gut Microbiota, and metabolic parameters in schizophrenia: A clinical observational study

Ministry of AYUSH, Government of India1 个研究点分布在 1 个国家目标入组 110 人开始时间: 2024年12月1日最近更新: 2024年11月16日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 110
试验地点: 1
主要终点: PRIMARY OUTCOME MEASURES

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aims to assess the effects of Virechana Karma, (which is one among the 5 Panchakarma procedures), on vagal tone, gut microbiota composition, and biochemical markers in individuals with Schizophrenia. Virechana Karma involves three stages: Poorvakarma (preparatory phase), Pradhanakarma (main purgation), and Samsarjana Krama (post-therapy recovery). The study adopts a longitudinal design with two arms: a case-control baseline comparison and a pre- and post-intervention analysis. Participants will be divided into two groups: schizophrenia (SCZ), and healthy controls (HC). The SCZ group will undergo a 13-25 day Virechana Karma regimen involving Deepana Pachana (Chitrakadi Vati), Snehapanam (Kalyanakaghrita), and Virechana with Trivruth Avaleha. Baseline and post-treatment assessments will include heart rate variability (HRV), Electrogastrography (EGG), gut microbiota sequencing, liver function tests, lipid profiles, serum electrolytes, and clinical scales such as BPRS, CGI, SANS, SAPS, GSRS, WHO-QOL, PSS. The primary outcomes focus on changes in vagal tone and gut microbiota, while secondary outcomes involve biochemical and clinical parameters. The research also aims to elicit Virechana Karmaâ€™s mechanistic potential while improving physiological and mental health in schizophrenia patients.

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: All

入选标准

•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
•Diagnosed patients of Unmada according to Ayurveda and Patients of Schizophrenia spectrum disorders as per DSM-
•Schizophrenia patients on treatment with antipsychotics (except clozapine) and on stable medication for at least six weeks
•Persistence of moderate or greater severity of positive or negative symptoms as assessed with SAPS and SANS ( â‰¥ 3 severity of SAPS (Item numbers 7, 20, 25, 34) and SANS (Item numbers (7, 13, 17, 22).
•Subjects between 18 years and 45 years of age.
•Patients who are on stable medications at least for a month.
•Healthy Controls Inclusion criteria
•Age range: 18 â€“ 45 years
•Both sexes
•Ready to sign the informed consent form.

排除标准

•Schizophrenia Exclusion criteria
•Patients with psychosis other than schizophrenia, neurotic disorders like anxiety, OCD, substance use disorders, major systemic illness, neurological disorders and immune system disorders
•Patients treated with any antibiotics or Probiotic/Prebiotic agents in the previous month;
•Patients with suicidal tendencies
•Pregnant and lactating mothers
•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.
•Patients with uncontrolled Diabetes mellitus, Hypertension, severe Hepatic Renal and Pulmonary Dysfunction.
•Healthy Controls Exclusion criteria
•Diagnosis of any psychiatric or neurological disorder
•Family history of psychiatric or neurological disorder in any of the first-degree relatives
•Any immune disorder or medical disorder interfering with the research.