| CTRI Number |
CTRI/2024/09/074361 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Homoeopathic Medicines for the treatment of Depression in Young Adults |
|
Scientific Title of Study
|
Efficacy of Homoeopathic Medications for the Treatment Of Depression utilizing HDR SCALE AND PHQ-9 SCALE in Early Adulthood: A Randomized, Single-Blind, Prospective, Unicentric, Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreya N |
| Designation |
Doctor, PG Scholar |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre, Pune-Bangalore Highway
Pune
MAHARASHTRA
411043
India |
| Phone |
8489719291 |
| Fax |
|
| Email |
doctorsreyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mrinal A Nerlekar |
| Designation |
MD(HOM) Head of Department of Practice of Medicine |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre, Pune-Bangalore Highway
Pune
MAHARASHTRA
411043
India |
| Phone |
9422321397 |
| Fax |
|
| Email |
Mrinal.nerlekar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mrinal A Nerlekar |
| Designation |
MD(HOM) Head of Department of Practice of Medicine |
| Affiliation |
BVDU Homoeopathic Medical College, Department of Post Graduate and Research Centre |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre, Pune-Bangalore Highway
Pune
MAHARASHTRA
411043
India |
| Phone |
9422321397 |
| Fax |
|
| Email |
Mrinal.nerlekar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| BVDU Homoeopathic Medical College and Hospital, Dept. of Post Graduation and Research Centre, Pune, Maharashtra 411043 |
|
|
Primary Sponsor
|
| Name |
Dr. Sreya N |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre, Pune-Bangalore Highway, Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Sreya N |
BVDU Homoeopathic Medical College and Hospital, Department of Post Graduation and Research centre |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic Medical College and Hospital, Dept. of Post Graduate and Research Centre, Pune-Bangalore Highway
Pune
MAHARASHTRA |
8489719291
doctorsreyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bharati Vidyapeeth (DTU) HMC, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic Medications, Medicine will be selected after case taking and individualization of each case |
Potentised Homoeopathic Medications Selected Based on the Symptoms Similarity will be administered in the form of pills or powder.
Dose will be selected from Centesimal scale or 50 Millesimal scale of potency based on the Susceptibility and Sensitivity of each Individual case and repetition of medicine will be based on the susceptibility of patient and response to the treatment,follow-up after every 15 days for a period of 6 months.
Route of Administration: Oral |
| Comparator Agent |
Sac Lac will be administered |
Sac Lac in the form of pills
Dose: Four pills thrice a day
Route of Administration: Oral
Follow-up will be taken 15 days once for a period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Case Definition - The following signs and symptoms if present nearly every day for at least 2 weeks or more:
Persistent sad, anxious, or “empty†mood
Feelings of hopelessness, pessimism
Feelings of guilt, worthlessness, helplessness
Loss of interest or pleasure in hobbies and activities
Decreased energy, fatigue, being “slowed downâ€
Difficulty concentrating, remembering, making decisions
Difficulty sleeping, early-morning awakening, or oversleeping
Appetite and/or unwanted weight changes
Thoughts of death or suicide; suicide attempts
Restlessness, irritability Persistent physical symptoms, such as muscle pain or headaches.
2. Patients assessed using both HDR and PHQ9 Scale with the values of HDR Scale Score - greater than or equal to 10 and less than or equal to 18.
PHQ9 Scale Score- greater than or equal to 5 and less than or equal to 20.
3. Patients fulfilling scores of both scales simultaneously will only be considered.
4. Cases that fulfil the case definition along with assessment scores will only be included.
5. Patients irrespective of socio-economic status.
6. Patients already diagnosed with depression but not under any medications.
7. Patients with washout period of more than 6 months but satisfy case definition. |
|
| ExclusionCriteria |
| Details |
1. Age group of below 18 years and above 30 years.
2. Patients not fulfilling the case definition.
3. Patients who do not satisfy the assessment scores or the scores are only valid in one of the scales used for assessment.
4. Patient already diagnosed and under treatment for depression.
5. Patient under anti-psycotic or anti-depressant drugs.
6. Patient who need emergency medical or surgical intervention.
7. Patients diagnosed with severe depression, depression associated with other medical conditions like cancer, bipolar disorders, anxiety and other unspecified mood disorders and depression with psychotic symptoms like hallucinations.
8. Patients with washout period less than 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the efficacy of Homoeopathic medications in the treatment of depression in early adulthood. |
Follow up every 2 weeks for a period of 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand is there any clinical significance of homoeopathic medications in the treatment of depression in early adulthood. |
Follow up every 2 weeks for a period of 6 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
23/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised, prospective, interventional study to understand efficacy of homoeopathic medicines in treatment of depression in early adulthood. Primary objective is to understand is there any clinical significance of homoeopathic medications in treatment of depression in early adulthood. Secondary objective is to understand the acceptability of homoeopathic treatment for depression. Patient satisfying the inclusion criteria will be enrolled into two groups using computer randomisation. Group A will receive homoeopathic intervention and group B will receive placebo. A minimum of 60 patients will be enrolled. Duration of the treatment will be of 6 months with follow up every 2 weeks. The diagnosis and the assessment of the patients will be done using HDR Scale and PHQ9 Scale. A discontinuation criteria assessment and outcome assessment will be carried out during each follow up. The pre and post study scores of all patients will be analyzed using statistical test. |