Homoeopathic treatment of depression in women after menopause

Phase 2

• Conditions: Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified

• Registration Number: CTRI/2023/03/050270
• Lead Sponsor: D N De Homoeopathic Medical College and Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Menopausal women with depression diagnosed as having the following -

a) Typical Symptoms: Depressed mood, loss of interest and enjoyment, increased fatigability and diminished activity

b) Common Symptoms: Reduced concentration and attention, reduced self-esteem and self-confidence, guilt feeling and unworthiness (mild type of episode), bleak and pessimistic view of the future, ideas or acts of self-harm or suicide, disturbed sleep, and diminished appetite

2. Age between 40 and 65 years

3. Woman, who has gone twelve months without menses

4. Mild and moderate depression [HDRS score: 8-13 mild, 14-18 moderate]

5. Literate patients: ability to read English, Hindi and Bengali. Illiterate patients will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.

6. Providing with written inform consent voluntarily

Exclusion Criteria

1.No depression [HDRS Score: 0-7], or severe depression [HDRS score 18 or above]

2.Mood disturbance when associated with bipolar affective disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder.

3.Currently receiving any effective anti-depressant.

4.Active suicidal thoughts.

5.Depression due to some organic disease or physiological effects of any medicine.

6.Hysterectomy and receiving any kind of hormone therapy.

7.Presence of medical conditions such as diabetes, hypertension, cardiac disorder & thyroid disorder.

8.Undergoing homoeopathic treatment for any chronic disease within last six months.

9.Vulnerable population - unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, institutionalized subjects, mentally incompetent people.

10.Self-reported immune-compromised state.

11.Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.

12.Simultaneous participation in any other clinical trials.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamiltonâ??s Depression Rating Scale (HDRS)Timepoint: At baseline, after 1 month and 2 months of intervention.

Secondary Outcome Measures

Name	Time	Method
Menopause rating scale (MRS)Timepoint: At baseline, after 1 month and 2 months of intervention.;Montgomery-Asberg Depression Scale (MADRS):Timepoint: At baseline, after 1 month and 2 months of intervention.