Individualized homoeopathic medicines in managing depression in middle-aged married individuals: A double-blind, randomized, placebo-controlled trial - NI

D N De Homoeopathic Medical College and Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1) Patient with depression, anxiety and stress for at least 2 weeks (DSM V & ICD 11-Code 6A73).
•2) Middle-aged married individuals i.e., 40 – 60 years.
•3) Mild and moderate depression [DASS-10 mild: 6, moderate 7-12; DASS-21: 10-20 (mild to moderate depression), 8-14 (mild to moderate anxiety), 15-25 (mild to moderate stress).
•4) Participants having prior experience or knowledge of the treatment, e.g., primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet

•1. Not providing with written informed consent
•2. Mood disturbance when associated with bipolar affective disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder with suicidal tendency.
•3. Currently receiving any effective anti-depressant.
•4. Any life-threatening diseases on recently active physical disease.
•5. In some condition when requiring emergency or surgical intervention.
•6. Depression due to some organic disease or physiological effects of any medicine, hysterectomy and receiving any kind of hormone therapy.
•7. Presence of medical conditions such as uncontrolled diabetes Mellitus Type 2, uncontrolled hypertension, uncontrolled hypothyroidism.
•8. Pregnancy, puerperium, lactating women.
•9. History of myocardial infarction, stenting, coronary artery bypass surgery or stroke.
•10. Undergoing homoeopathic treatment for any chronic disease within last six months.
•11. Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, institutionalized subjects, mentally incompetent people.
•12. Self-reported immune-compromised state.
•13. Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
•14. Simultaneous participation in any other clinical trial

发起方

D N De Homoeopathic Medical College and Hospital