Synergistic Effect of Vitamin E & D in Reducing Risk of Effects Associated With Atypical Anti-psychotics
- Registration Number
- NCT06200584
- Lead Sponsor
- Dr Rabia Arshad
- Brief Summary
Atypical antipsychotic drugs are commonly used to treat psychiatric illnesses but they are significantly associated with side effects including acute dystonia, akathisia, parkinsonism (rigidity and tremor), tardive dyskinesia, bradycardia, hypotension, impotence, sleepiness, seizures, severe dreams or nightmares, and hyperprolactinaemia. Vitamin D and E, hav...
- Detailed Description
Inclusion Criteria:
1. Patients using antipsychotic medications such as quetiapine, olanzapine, or risperidone 3. Participants who are between the ages of 20 - 70 years 3. Both gender patients male and female 4. Patients with no other chronic morbidity
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- Those using antipsychotic medications such as quetiapine, olanzapine, or risperidone.
- Participants who are between the ages of 20 - 70 years are both sex male and female
- participants who are taking a combination of one or two antipsychotics.
- Participants who were under antipsychotic therapy and not diagnosed with type 2 diabetes mellitus.
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Patients at mental hospitals are mostly women who are either pregnant or nursing.
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Patients who were taking anticonvulsants, ketoconazole, or corticosteroids, or who had a history of other mental or neurologic illnesses, as well as those who used phosphor, calcium, vitamin D supplements or teriparatide, were not included in the study.
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Participants were also ruled out if they had preexisting conditions including renal or hepatic failure or a parathyroid disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description psychotic patients Risperidone and Vitamin D and Vitamin E treatment given psychotic patients Olanzapine and Vitamin D and Vitamin E treatment given psychotic patients Quetiapine and Vitamin D and Vitamin E treatment given psychotic patients Olanzapine treatment given psychotic patients Quetiapine treatment given psychotic patients Risperidone treatment given
- Primary Outcome Measures
Name Time Method Glutathione Peroxidase 6months Serum levels of Glutathione Peroxidase would be determined in each group using a colorimetric approach and commercially available kits because both enzymes are commonly involved in the response to oxidative stress in tissue.(GPX ELISA kit )
Lipid Profile total cholesterol 6months The lipid profile includes the measurement of total cholesterol level in the blood
anti inflammatory markers gamma interferon 6months Expression levels of interferon gamma are determined by polymerase chain reaction. Primers specific to TNF- and IFN- were designed and synthesized for use in polymerase chain reaction (PCR) copy synthesis.
Superoxide Dismutase Activity 6 months Superoxide Dismutase were determined in each group using a colorimetric approach and commercially available kits
lipid profile TG 6 months The lipid profile includes the measurement of triglycerides level in the blood
lipid profile HDL 6 months The lipid profile includes the measurement of high density lipoproteins in the blood
lipid profile VLDL 6 months The lipid profile includes the measurement of very low density lipoprotein levels level in the blood
anti inflammatory markers TNF alpha 6 months Tumor necrosis factor alpha expression is determined by polymerase chain reaction.
- Secondary Outcome Measures
Name Time Method Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS) 6month The Brief Mental Rating Scale (BPRS) is a frequently used measure in psychiatry for assessing the severity of various mental symptoms. It is intended to assess the psychological and behavioral features of those suffering from mental health issues. The BPRS is made up of 18 components, each reflecting a different symptom domain. maximum score 168 and minimum ...
Trial Locations
- Locations (1)
Jinnah Post Graduate Medical Centre
🇵🇰Karachi, Sindh, Pakistan