Efficacy of individualized homoeopathic medicines in improving symptoms of post-traumatic stress disorder in individuals aged 18-45 years: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Clinician-administered PTSD scale (CAPS-5) score for DSM-5
研究概览
简要总结
PTSD is a major psychiatric disorder that results from exposure to real or threatened death, serious injury, or sexual assault or other traumatic events. PTSD is a common disorder after exposure to trauma and is one of the serious health concerns that is associated with comorbidity, functional impairment, and increased mortality with suicidal ideations and attempts. The symptoms of PTSD include persistently re-experiencing the traumatic event, intrusive thoughts, nightmares, flashbacks, detachment from oneself or reality, and intense negative emotional (sadness, guilt) and physiological reaction on being exposed to the traumatic reminder. Furthermore, problems with sleep and concentration, irritability, increased reactivity, increased startle response, hypervigilance, avoidance of traumatic triggers also occur. There is a significant impairment in social, occupational, and other areas of functioning. For a patient to be diagnosed as PTSD, the duration of the symptoms must be more than one month. Though he use of homoeopathic medicines is extensive globally to treat PTSD, diligent research evidence in favour of homoeopathy is not well marked. So, we intend to undertake the research to evaluate the efficacy and safety of homoeopathic medicines in the treatment of PTSD. Thus this double-blind, randomized (2:1), placebo-controlled trial using individualized homoeopathic medicines along with concomitant care will be conducted upon 66 patients suffering from PTSD in both out-patient department and in-patient departments of D. N. De Homoeopathic Medical College & Hospital. Primary outcome measure will be CAPS-5 score. PCL-5 and MYMOP-2 will be secondary outcome measures. All outcomes will be measured at baseline, every month and up to 3 months. Group differences will be analized statistically. The results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient suffering from PTSD [ICD-11 code-6B40] and CPTSD [ICD-11 code-6B41], diagnosed as per DSM-V criteria, (CAPS-5 Score 23-50)
- •Patients aged from 18 to 45 years
- •Patients of either sex and transgender
- •Participants having prior experience or knowledge of the treatment.
- •Ex.- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •Patients not providing with informed consent voluntarily
- •A primary psychiatric diagnosis other than PTSD
- •Suicidal tendency, patient on current medications (antidepressants, mood stabilizers or anti-psycotics, regular use of benzodiazepines, opioid based analgesics)
- •Recently commenced psychotherapy
- •Patient unwilling to discontinue the anti-psycotic or any other antidepressant medicine
- •Known clinical uncontrolled systemic disorders
- •Vulnerable population: Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people
- •Patients already suffering from eating disorders
- •Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence using TAPS TOOL
- •Self-reported immune-compromised state
- •Already undergoing homoeopathic treatment for chronic disease within last 6 months
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Clinician-administered PTSD scale (CAPS-5) score for DSM-5
时间窗: At baseline, every month, up to three months
次要结局
- PTSD checklist (PCL-5) score for DSM-5(At baseline, every month, up to three months)
- Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2) questionnaire(At baseline, every month, up to three months)
研究者
Supriti Mondal
D. N. De Homoeopathic Medical College and Hospital