Efficacy of Add-on Homoeopathy and Cognitive Behaviour Therapy in Binge Eating Disorder in adolescents: A Randomized, Single- Blind placebo controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess the changes in symptoms of binge eating disorders using Eating Disorder Examination Questionnaire
研究概览
简要总结
This randomized, single-blind, placebo-controlled pilot study is designed to evaluate the efficacy of add-on Homoeopathy with Cognitive Behavioural Therapy (CBT) in adolescents with Binge Eating Disorder. The study will be conducted at the Peripheral OPD / OPD of Bakson Homoeopathic Medical College & Hospital, Greater Noida and OPD of CCRH institute/units over a 3 years period. A total of 90 participants aged above 12- 18 years meeting inclusion criteria based on DSM-5 criteria will be enrolled. The primary outcome will be assessed by changes in anxiety associated symptoms General Anxiety Disorder-7 at baseline, 03 months and 6 months and secondary outcomes will include Body Image related aptitudes assessed at baseline, 03 months and 6 months and assessment of risk factors for metabolic syndrome - Lipid profile (Serum triglycerides, LDL, HDL, Total cholesterol), Blood Sugar (Fasting, HbA1c) assessed at baseline, 03 months, and 06 months. Blood pressure and Obesity assessed at every month till 06 months. Serum Fasting Insulin levels, and Hormonal profiling [Thyroid profile (T3, T4, TSH), FSH, LH, Prolactin, Testosterone, E2 Estradiol, progesterone] for subset of participants (i.e. participants who are overweight or obese or BMI above 25 kg/m square) assessed at baseline and 06 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants with ages between 12-18 years, of all gender.
- •2.Participants meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Binge Eating Disorder that is Recurrent episodes of binge eating, an episode of which includes eating, in a discrete period of time and a sense of lack of control over eating during the episode also the criteria includes binge-eating episodes which are associated with three (or more) of eating much more rapidly than normal, or eating until feeling uncomfortably full, or eating large amounts of food when not feeling physically hungry, or eating alone because of feeling embarrassed by how much one is eating, or feeling disgusted with oneself, depressed, or very guilty afterwards, or marked distress regarding binge eating is present.
- •Along with this the criteria includes that binge eating occurs, on average, at least once a week for three months and the binge eating is not associated with the recurrent use of inappropriate compensatory behavior (for example, purging) and does not occur exclusively during the course of anorexia nervosa, bulimia nervosa or avoidant/restrictive food intake disorder.
排除标准
- •1.Participants already undergoing treatment (Allopathic, Ayurveda, Homoeopathic) for any other systemic disorders.
- •2.Participants currently using anti-diabetic medication; contraceptive pills; medications with effect on lipid metabolism i.e. thiazide and loop diuretics, beta and alpha receptor blockers; anti-epileptic drugs, anti-psychotics medications regularly over the last 1 month or more 3.Participants currently using immunosuppressive treatments 4.Morbid obesity – BMI greater than 40 kg/m2 5.Severe obesity (BMI greater than 30 kg/m2 ) with related comorbidities such as hypertension or dyslipidemia 6.HbA1c 6.5 percent or higher 7.Hypertriglyceridemia greater than or equal to 130 mg/dL 8.Pregnant and lactating women 9.Participants suffering from systemic and other endocrine disorders e.g. uncontrolled Hypertension, Type I/Type II Diabetes Mellitus, Diabetes Insipidus, Cushing Syndrome, Addison’s disease, Insulin Resistance syndrome 10.Participants suffering from other eating disorders such as anorexia nervosa, and bulimia nervosa.
- •11.Participants with psychiatric disorders viz.
- •schizophrenia, bipolar disorder, Major Depressive Disorder, on medication for depression, anxiety, phobias etc.
结局指标
主要结局
To assess the changes in symptoms of binge eating disorders using Eating Disorder Examination Questionnaire
时间窗: Assessed at baseline, 03 months , and 06 months
次要结局
- To assess the change in anxiety associated symptoms General Anxiety Disorder-7(Assessed at baseline, 03 months , and 06 months)
- To assess changes in Body Image related aptitudes.(Assessed at baseline, 03 months , and 06 months)
- To assess Lipid profile (Serum triglycerides, LDL, HDL, Total cholesterol), Blood Sugar (Fasting, HbA1c)(Assessed at baseline, 03 months , and 06 months.)
- To assess Blood pressure and Obesity(Assessed at every month till 06 months)
- To assess Serum Fasting Insulin levels(Assessed at baseline and 06 months.)
- To assess Hormonal profile [Thyroid profile (T3, T4, TSH), FSH, LH, Prolactin, Testosterone, E2 Estradiol, progesterone] for subset of participants (that is participants who are overweight or obese or BMI above 25 kg/m square)(Assessed at baseline and 06 months.)
研究者
Dr Divya Taneja
Central Council for Research in Homoeopathy