Double-blind, randomized, placebo-controlled trial of add-on individualized homoeopathic medicines with cognitive and behavioural therapy in improving anxiety in adults with generalized anxiety disorder
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Rating Scale (HAM-A)
研究概览
简要总结
Generalized anxiety disorder (GAD) is excessive anxiety and worry, occurring more days than not for at least 6 months, about a number of events. The individual finds it difficult to control the worry. The anxiety and worry are associated with restlessness, being easily fatigued, difficulty concentrating, irritability, muscle tension, sleep disturbance. Anxiety disorders affect over a tenth of the population with increasing incidence. Among anxiety disorders GAD has the highest prevalence, it affects 4–6% of the general population. Homoeopathy may have immense potential to offer in the successful treatment of GAD. We intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of GAD in adults. A double blind, randomized (1:1), placebo-controlled trial will be conducted on 96 adults who are suffering from GAD at the outpatient department of D.N. De Homoeopathic Medical College and Hospital. Assessment will be done by Hamilton Anxiety Rating Scale(HAM-A) [primary Outcome], GAD-7 score, The Hamilton Rating Scale for Depression (HDRS) score, Patient Health Questionnaire (PHQ9) score [secondary Outcomes], all to be measured at baseline, every month, up to 3 months. Comparative analysis will be carried out to detect group differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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 suffering from GAD (ICD code F41.1) diagnosed as per DSM-V criteria diagnosis confirmed through HAM-A (score 8-23).
- •Initial screening for potential GAD cases will be done by using GAD-2 scoring (GAD 2 score 3 or higher) 2.Age between 18 and 65 years 3.Patients of either sex 4.Literate patients; ability to read English, Hindi and/or Bengali 5.Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires 6.Patients undergoing any treatment for GAD included after discontinuing the same following a washout period of 15 days if the patient agreed.
排除标准
- •1.Minimal (HAM-A score 7 or less) and severe (HAM-A score 24 or more).
- •2.A primary psychiatric diagnosis other than GAD.
- •3.Suicidal tendency, pertinent current medications (anti-depressants, mood stabilizers or anti-psychotics, regular use of benzodiazepines, opioid based analgesics) 4.Three or more failed trials of pharmacotherapy for current GAD episode 5.Recently commenced psychotherapy 6.Patient unwilling to discontinue the antipsychotic or any other antidepressant medicine 7.Known clinical uncontrolled systemic disorder like uncontrolled diabetes, uncontrolled hypertension.
- •8.Vulnerable population- unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
- •9.Other uncontrolled or life-threatening illness affecting quality of life or any organ failure 10.Pregnant and puerperal women, lactating mothers 11.Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence 12.Self-reported immune-compromised state 13.Already undergoing homoeopathic treatment for chronic disease within last 6 months.
- •14.Simultaneous participation in any other clinical trail.
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: At baseline, every month, up to 3 months
次要结局
- Patient Health Questionnaire (PHQ9)(At baseline, every month, up to 3 months)
- Generalized Anxiety Disorder 7 (GAD-7) questionnaire(At baseline, every month, up to 3 months)
- Hamilton Depression Rating Scale (HDRS) questionnaire(At baseline, every month, up to 3 months)