An Open Lable Comparative Clinical Study On The Effectiveness Of Homoeopathic Medicine Through Homoeopathic Medical Repertory Vis-Ã -vis Bach Flower Remedies In Cases Of Major Depressive Disorder
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Vidhyadeep Homoeopathic Medical College And Research Center Anita Kim
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reduction in severity of depressive symptoms as assessed by Hamilton Depression Rating Scale (HAM-D)
Overview
Brief Summary
This study is an open-label, randomized clinical trial designed to compare the effectiveness of two different homeopathic treatments for Major Depressive Disorder (MDD). It aims to evaluate traditional repertory-based homeopathic medicine versus Bach Flower Remedies over a treatment period of six months. The research follows a parallel group, active-controlled design and will be conducted over three years, involving 100 participants.Participants will be randomly assigned to one of two groups. The experimental group will receive Bach Flower Remedies, taken as 1-4 drops in a cup of water, while the control group will be treated with traditional homeopathic medicines, prescribed based on individual case analysis using a homeopathic repertory. Both groups will undergo case management for six months, with follow-ups based on individual needs.The study’s primary goal is to measure the reduction in depressive symptoms using the Hamilton Depression Rating Scale (HAM-D). A secondary objective is to assess improvements in the psychological dimension of health. The study is open to men and women aged 18 to 80 years, diagnosed with depression according to the DSM-5 diagnostic criteria, and assessed using the HAM-D scale. Participants with systemic diseases or a history of psychiatric medication use can also be included. However, individuals who fail to follow up regularly, do not meet the DSM-5 and HAM-D criteria, or have a history of suicidal attempts, substance abuse, or critical illness with poor prognosis will be excluded. Pediatric cases, pregnant and breastfeeding women, and individuals unwilling to provide written consent will also not be included.The significance of this study lies in its potential to offer scientific evidence on the effectiveness of homeopathic treatments for depression. By comparing these two approaches, the research may help identify alternative treatment options for managing Major Depressive Disorder, benefiting both patients and healthcare practitioners.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Cases irrespective of gender, education, occupation, ethnicity 2) Both sexes of 18 to 80 years of age group 3) Cases which are diagnosed as depression as per DSM-5 diagnostic criteria and scored based on HAM-D scale 4) Cases with systemic pathology will be included in this study 5) Cases with previous drug history of psychiatric drug will be included in this study.
Exclusion Criteria
- •Cases with irregular follow ups 2) Cases which do not full fill the diagnostic criteria of DSM-5 and HAM-D scale 3) Pediatric cases, gestational as well as lactational women will be excluded 4) Cases with past history of suicide attempts or threat 5) Cases with substance abuse (Chronic alcoholism, drugs, chain smokers, etc.) 6) Cases with critical condition with poor prognosis will be excluded from the study 7) Those individual who are unwilling to provide written consent for participation in this research study will be Excluded.
Outcomes
Primary Outcomes
Reduction in severity of depressive symptoms as assessed by Hamilton Depression Rating Scale (HAM-D)
Time Frame: Measured at baseline and at the end of the 6 months treatment period.
Secondary Outcomes
- improvement in psychological symptoms indicators (assessed using validated questionnaires or scale)at baseline and the end of the 6-month treatment(Measured at baseline and at the end of the 6-months treatment period.)
Investigators
Dr Harshnaben Sirishkumar Goti
Vidhyadeep Homoeopathic Medical College And Research Center Vidhyadeep University.