A Clinical Study to Evaluate the Role of Individualized Homoeopathic Medicine among adults having Generalized Anxiety Disorder using Hamilton Anxiety Rating Scale (HAM-A)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
研究概览
简要总结
Generalized Anxiety Disorder (GAD) is a Chronic psychiatric condition characterized by excessive anxiety and worry occurring more days than not for at least 6 months, about a number of events or activities often accompanied by symptoms such as restlessness, fatigue, irritability, muscle tension, and sleep disturbance. It significantly affects daily functioning and quality of life.
Homoeopathy emphasizes individualized treatment based on the principle of similia similibus curentur, where a medicine is selected according to the totality of symptoms of the patient. Individualized homoeopathic medicines aim to restore mental and physical balance and improve overall well-being.
This single-arm pre–post clinical study aims to evaluate the role of individualized homoeopathic medicine in adults with Generalized Anxiety Disorder. A total of 38 participants aged 18–65 years diagnosed with GAD according to DSM-5 criteria and having mild to moderate anxiety (HAM-A score 8–23) will be enrolled from the OPD and IPD of the National Institute of Homoeopathy, Narela, Delhi. total study duration will be 6 months. Participants will receive individualized homoeopathic treatment for 3 months, with follow-up every two weeks.
The primary outcome will be the change in anxiety severity measured using the Hamilton Anxiety Rating Scale (HAM-A) at baseline and after 3 months of treatment. The Modified Naranjo Criteria for Homeopathy (MONARCH) will be used to evaluate the causal relationship between the intervention and clinical outcome. If any ADR occur ,we will report to the competent authority and nearest pharmacovigilance centre.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged 18–65 years diagnosed with Generalized Anxiety Disorder as per Diagnostic and statistical manual of mental disorder 5 Text Revision diagnostic criteria.
- •2.Participants of all gender and from all socioeconomic and religious backgrounds will be included.
- •3.Patients with Hamilton Anxiety scale defined mild 8–14 and moderate 15–23 anxiety are included.
- •4.Participants willing to participate and giving written informed consent.
排除标准
- •1.Patients who develop severe anxiety during the study period such cases will be referred for appropriate care and excluded from the study 2.Patient currently receiving allopathic medications for anxiety disorder.
- •3.Presence of psychiatric comorbidities such as schizophrenia, bipolar disorder, severe depression with suicidal risk.
- •4.Presence of unstable or serious medical illnesses such as uncontrolled diabetes, thyroid disease, cardiovascular disease, hepatic or renal failure, neurological disorders that may interfere with treatment or assessment.
- •5.Pregnant and lactating mother 6.Patient taking homoeopathic medicine for any other systemic disease since last 6 month 7.Simultaneous participation in any other clinical trial.
研究者
Dr Sumera
National Institute Of Homoeopathy, Delhi, A-8,Chaudhary Ramdev Chowk, Narela, Delhi-110040