Authors
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D N De Homoeopathic Medical College and Hospital -More
Category
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Primary study
Registry of Trials»Clinical Trials Registry - India
Year
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2026
INTERVENTION: Intervention1: IHMs in 50‐millesimal or LM potencies plus CBT as concomitant care: Intervention is planned as administering IHMs in 50‐millesimal or LM potencies, as appropriate to the case or conditions. A single medicated cane sugar globule of poppy seed size [no. 10] is dissolved in 80 mL of distilled water with the addition of 2 drops of 90% v/v ethanol, and 14 doses are marked on the vial. After 10 uniformly forceful downward strokes to the vial, each dose of 5 mL is instructed to be mixed with 45 mL normal water in a clean cup, to stir well, to take 5 mL of it orally on a clean tongue, and to discard the rest of the liquid from the cup. All medicines and sundry items will be procured from a Good Manufacturing Practice‐certified firm. The baseline prescription began with an LM1 potency in every case. Potencies are increased during follow up after a consensus among the physicians. Both medicines and placebos will be repacked in identical glass bottles and labeled with code, name of medicine, and potency, and will be dispensed according to the random number list. A single homoeopathic medicine will be prescribed at each consultation based on individualization. The selection of the remedy for each case will be carried out by analyzing the totality of symptoms, with emphasis on those that are characteristic [i.e., well defined, intense, and peculiar], in accordance with the principles outlined in the Organon of Medicine [6th edition aphorisms 95, 104, 153, 154, and 164]. Relevant Materia Medica will be consulted, and the final selection of the medicine and its dosage will be determined through consensus among three qualified homoeopathic practitioners. Cognitive Behavioural Therapy will be given as concomitant care. Control Intervention1: Placebo plus CBT as concomitant care: Placebos that is identical in appearance to the verum. Patients will be examined similarly by the three homeopaths as in the verum group. A single nonmedicated cane sugar globule of poppy seed size [no. 10] will be dissolved in 80 mL of distilled water with the addition of 2 drops of 90% v/v ethanol, and 14 doses will be marked on the vial. Instructions will the same as in the verum group. Cognitive Behavioral Therapy as concomitant care. CONDITION: Health Condition 1: F331‐ Major depressive disorder, recurrent, moderate PRIMARY OUTCOME: Hamilton Depression Rating Scale [HDRS 17]Timepoint: Baseline and every 14 days up to 4 months SECONDARY OUTCOME: Geriatric Depression Scale 15 [GDS‐15]Timepoint: Baseline and every 14 days up to 4 months Measure Yourself Medical Outcome Profile 2 [MYMOP 2]Timepoint: Baseline and every 14 days up to 4 months INCLUSION CRITERIA: A. Elderly people with depression of not less than two weeks duration, with a minimum of two typical and two common symptoms will be included in the study. Typical symptoms 1. Depressed mood 2. Loss of interest and enjoyment. 3. Increased fatigability and diminished activity Common symptoms 1. Reduced concentration and attention. 2. Reduced self esteem and self confidence. 3. Guilt feeling and unworthiness [mild type of episode] 4. Bleak and pessimistic view of the future 5. Disturbed Sleep 6. Diminished appetite B. Age above 60 years C. Mild and moderate depression [HDRS score 8 to 13 mild, 14 to 18 moderate] D. GDS 15 score more than 5
Epistemonikos ID: b09e26b209c7c09f7a403aebffb0f2ddbb788a0d
First added on: Oct 08, 2026