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A Natural herb Daruharidra to help with weight and other side effects from mental health medications

An Open-label trial evaluating the feasibility and efficacy of Daruhaidra (Berberis aristata) for Antipsychotic induced weight gain and Metabolic syndrome. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088942
Enrollment
30
Registered
2025-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F20- Schizophrenia Health Condition 2: F21- Schizotypal disorder Health Condition 3: F22- Delusional disorders Health Condition 4: F23- Brief psychotic disorder Health Condition 5: F25- Schizoaffective disorders

Interventions

None listed

Sponsors

Dr Saranya Raghavan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Diagnosed patients of Unmada according to Ayurveda and Patients of Schizophrenia spectrum disorder and other psychotic disorder as per DSM 5 2)Patients satisfying the International diabetes federation criteria for metabolic syndrome. According to the new IDF definition, for a person to be defined as having the metabolic syndrome they must have Central obesity (defined as waist circumference(i) with ethnicity specific values) plus any two of the following four factors a. Raised Triglycerides greater than or equal to 150 mg per dL (1.7 mmol per L) or specific treatment for this lipid abnormality b. Reduced HDL cholesterol lesser than 40 mg per dL (1.03 mmol per L) in males lesser than 50 mg per dL (1.29 mmol per L) in females or specific treatment for this lipid abnormality. c. Raised blood pressure systolic BP greater than or equal to 130 or diastolic BP greater than or equal to 85 mm Hg or treatment of previously diagnosed hypertension. d. Raised fasting plasma glucose (FPG) greater than or equal to 100 mg per dL (5.6 mmol per L), or previously diagnosed type 2 diabetes. e. If above 5.6 mmol per L or 100 mg per dL, OGTT is strongly recommended but is not necessary to define the presence of the syndrome. (i) If BMI is greater than 30kg per m2, central obesity can be assumed and waist circumference does not need to be measured. 3) Patients on stable dose of antipsychotic medication for past 8 weeks. 4) Patients with metabolic syndrome on antipsychotic medication with BMI greater than 25 kg per m2 and waist circumference greater than or equal to 90cm (male) greater than or equal to 80 (female) 5) Patients in the age group of 18 to 45 years irrespective of gender and socioeconomic status. 6) Patients willing to give an informed consent. 7)Participants who have the capacity to provide informed consent after understanding the nature, purpose, procedures, risks, and benefits of the study.

Exclusion criteria

Exclusion criteria: 1) Patients with persistent and uncontrolled thyroid dysfunctions. 2) Patients on medications for metabolic syndrome from any medical systems in the last 3 months 3) Patients with suicidal tendencies 4) Pregnant and lactating mothers 5) Patients diagnosed with any psychiatric disorders other than schizophrenia spectrum disorder. 6) Peptic ulcer and any major systemic illness like cardiovascular diseases.

Design outcomes

Primary

MeasureTime frame
BMI Body Anthropometry (Waist and hip circumference)Timepoint: Baseline and after 12 weeks

Secondary

MeasureTime frame
Lipid profile FBS HOMA-IR CRP LFT RFT Blood pressure Fibroscan ELISA(P-AMPK) The enzyme-linked immunosorbent assay (ELISA) is a highly sensitive and reproducible method for quantifying P-AMPK levels in biological samples, making it an essential tool in metabolic research.Timepoint: Baseline After 12 weeks

Countries

India

Contacts

Public ContactDr Saranya Raghavan

National Institute of Mental Health And Neurosciences

drumeshayu@gmail.com9480815976

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026