| CTRI Number |
CTRI/2024/03/064577 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of depression |
|
Scientific Title of Study
|
Individualized homoeopathic medicines in managing depression in middle-aged married individuals: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-5291 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aiswarya Tripathy |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, OPD no. PG1 , Psychiatry and Medicine, D N De Homoeopathic Medical College and Hospital, 12 Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
7008040306 |
| Fax |
|
| Email |
alinatripathy95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhasish Ganguly |
| Designation |
Principal-in-Charge, Adminstrator and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, OPD no. PG1, Psychiatry and Medicine, D N De Homoeopathic Medical College and Hospital, 12 Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
8017272982 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhasish Ganguly |
| Designation |
Principal-in-Charge, Adminstrator and Head |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Organon of Medicine, OPD no. PG1, Psychiatry and Medicine, D N De Homoeopathic Medical College and Hospital, 12 Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
8017272982 |
| Fax |
|
| Email |
dr.subhasish67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda khatick Road, Tangra, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12,Gobinda Khatick Road, Tangra, Kolkata 700046 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aiswarya Tripathy |
D N De Homoeopathic Medical College and Hospital |
Dept of Organon of medicine OPD no. PG1, Psychiatry and Medicine, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL |
7008040306
alinatripathy95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De Homoeopathic Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus
concomitant care |
This group will receive identical-looking placebos. Each placebo dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue with empty stomach; dosage and repetition will be decided depending upon the individual requirement of the cases. All sundry items will be procured from a Good
Manufacturing Practice (GMP)
certified firm. All the enrolled patients will receive advice on concomitant care, i.e., Cognitive Behavioural Therapy, Yoga, and Pranayama. Duration of therapy: 3 months |
| Intervention |
Individualized homeopathic
medicines in centesimal
potencies plus concomitant care |
Intervention is planned as
administering indicated
homoeopathic medicines in
centesimal potencies (cH). Each dose will consist of 4 cane sugar globules no. 40
moistened with the indicated
medicine (preserved in 90% v/v
ethanol), to be taken orally on clean tongue with empty
stomach; dosage and repetition
depending upon the individual
requirement of the cases.
Patients will be advised to
refrain from handling the
globules or from eating,
drinking, smoking or brushing
teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified form. All the enrolled patients will receive advice on concomitant care, i.e. Cognitive Behavioural Therapy, Yoga ,and pranayama. Duration of
therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DASS 21 Questionnaire - depression subscale |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DASS 21 Questionnaire - Anxiety subscale |
Baseline, every month, up to 3 months |
| DASS 21 Questionnaire - Stress subscale |
Baseline, every month, up to 3 months |
| Stockholm Marital Stress Scale |
Baseline, every month, up to 3 months |
| Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2) |
Baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [alinatripathy95@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
Brief Summary
Modification(s)
|
Depression is “a period of at least two weeks when a person experienced a depressed mood or loss of interest or pleasure in daily activities, and had a majority of specified symptoms, such as problems with sleep, eating, energy, concentration, or self-worth.†This definition excludes grief after mourning . Stress is usually characterized by a sense of feeling overwhelmed. This feeling may be due to your coping capacity being over-stretched or having been under pressure for too long. Some stress can help us to perform our day-to-day functions, too much stress leaves us “distressed†and often exhausted . This double-blind randomized placebo-controlled trial intends to ascertain the probable significant treatment effect after using of Individualized Homoeopathic Medicine along with standard care will be conducted on 84 participants suffering from depression in both the outpatient and in-patient departments of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Depression, anxiety and stress questionnaire [Primary outcome], Stockholm Marital Stress Scale (SMSC) and Measure Yourself Medical Outcome Profile v2 (MYMOP-2) [Secondary outcomes], to be measured at baseline and every month, up to 3 months. This double- blind, randomized (2:1), placebo-controlled, parallel group efficacy trial will be an attempt to compare the effects of IHM in centesimal potencies against placebo. Group differences will be calculated on the intention-to-treat and per-protocol approaches. Results will be published in scientific journals. |