| CTRI Number |
CTRI/2025/05/087062 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To understand the role of homoeopathic remedy in the treatment of emotional state anxiety, depression and stress which is checked by DASS – 42 scale in OLD age group above 65 yrs in city area |
|
Scientific Title of Study
|
Exploring the action of Individualized Homoeopathic medicine on Emotional state - depression, anxiety and stress in Geriatric population by using DASS-42 ( Depression Anxiety Stress Scale ) Questionaries – in Urban Population, An experimental – Randomized Control trial |
| 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 Chirag Shah |
| Designation |
Professor |
| Affiliation |
Smt Malini Kishore Sanghvi Homoeopathic Medical College |
| Address |
Room No 13 Department of Physiology Smt Malini Kishore Sanghvi Homoeopathic Medical College Opp Sumeru Navkar Tirth Karjan
Vadodara
GUJARAT
391240
India |
| Phone |
9376939627 |
| Fax |
|
| Email |
chirashana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavita Malvi |
| Designation |
Professor |
| Affiliation |
P.P.Savani Homoeopathic Medical College |
| Address |
Room No F011 Department of Anatomy Nagarjunabhavan P. P. Savani Homoeopathic Medical College NH-8, near GETCO Village Dhamdod At and Po Kosamba Tal Mangrol
Surat
GUJARAT
394125
India |
| Phone |
9978198988 |
| Fax |
|
| Email |
bhavita.malvi@ppsu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chirag Shah |
| Designation |
Professor |
| Affiliation |
Smt Malini Kishore Sanghvi Homoeopathic Medical College, Karjan |
| Address |
Room No 13 Department of Physiology Smt Malini Kishore Sanghvi Homoeopathic Medical College Opp Sumeru Navkar tirth karjan amod road karjan
Vadodara
GUJARAT
391240
India |
| Phone |
9376939627 |
| Fax |
|
| Email |
chirashana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Care Well Homoeopathic And Child Guidance Clinic, Near Muktanand circle karelibaug vadodara - 390018 Gujarat India |
|
|
Primary Sponsor
|
| Name |
Dr Chirag Shah |
| Address |
care well homoeopathic and child guidance clinic karelibaug vadodara 390018 |
| 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 Chirag Shah |
P. P. Savani Homoeopathic Medical Hospital |
Room No F011 Department of Anatomy Nagarjunabhavan P. P. Savani Homoeopathic Medical College NH-8, near GETCO Village Dhamdod At and Po Kosamba Tal Mangrol
Surat
GUJARAT |
9376939627
chirashana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PPSU Ethical Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, (2) ICD-10 Condition: F439||Reaction to severe stress, unspecified, (3) ICD-10 Condition: F39||Unspecified mood [affective] disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Acute Homoeopathic Drug |
Argentinum Nitricum, Kali Phosphoricum, Natrum Sulphuricum, Etc..... |
| Intervention |
Individualised Homoeopathic Drugs |
Kali Carbonicum, Calcarea Carbonicum, Natrum Muraticum etc....... |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The patient is suffering from Anxiety, depression & stress diagnosed with the DASS-42 Scale. |
|
| ExclusionCriteria |
| Details |
i. Other Major and severe psychiatric conditions E.g. – MDD, Dysthymia, GAD, PTSD, Bipolar Disorder, Panic Disorder, Schizophrenia, etc…..
ii. Other Hormonal Disorders diagnosed with hormonal markers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A. To assess the changes in the Anxiety expressions (emotional State) after giving individualized constitutional medicine by DASS – 42 Q.
B. To assess the changes in the depression expressions (emotional State) after giving individualized constitutional medicine by DASS – 42 Q. |
at 3rd 6th and 9 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in the Stress expressions (emotional State) after giving individualized constitutional medicine every month by DASS – 42 Q. |
3rd 6th & 9 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
26/05/2025 |
| 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="0"
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
|
1. ALTERNATIVE HYPOTHESIS - Individualized homoeopathic medicine has an effect in the management for the emotional state – of depression, anxiety and stress in the Geriatric Urban Population 2. NULL HYPOTHESIS - Individualized homoeopathic medicine has no any effect in the management for the emotional state – of depression, anxiety and stress in the Geriatric Urban Population |