| CTRI Number |
CTRI/2025/11/097941 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on the effectiveness of homoeopathic medicines in managing bipolar disorder |
|
Scientific Title of Study
|
A Randomised control study to determine the effectiveness of homoeopathic polycrest remedies in the treatment of bipolar disorder with conventional therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupali |
| Designation |
PG scholar |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Centre |
| Address |
Near Riico Chownk Hanumangarh Road Sri Ganganagar
Psychiatry Department
Ground Floor
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8735940000 |
| Fax |
|
| Email |
rup6781@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalu munjal |
| Designation |
Guide |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Centre |
| Address |
Near Riico Bus Stand Hanumangarh Road SriGanganagar
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9660019001 |
| Fax |
|
| Email |
drsunilbishnoi84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupali |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Centre |
| Address |
Near Riico Bus Stand
Hanumamgarh Road Sri Ganganagar
Psychiatry Department
Ground Floor
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8735940000 |
| Fax |
|
| Email |
rup6781@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tantia university |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Centre Near Riico Bus Stand
Hanumamgarh road
Sri ganganagar
|
| Type of Sponsor |
Private 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 |
| Rupali |
Sri Ganganagar Homoeopathic Medical College Hospital And Research Institute |
Near Riico Bus Stand
Hanumamgarh Road
Sri Ganganagar
Ganganagar
RAJASTHAN |
08735940000
rup6781@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ganganagar Homoeopathic Medical College Hospital And Research Centre Sri Ganganagar Homoeopathic Medical College Hospital And research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathy |
Homoeopathic polycrest remedies
Starting with small dosage 30 potency and increasing it to 200 potency depending upon the severity of the symptoms
Route of administration will be oral |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient aged 18 to 50 years with clinically diagnosed with bipolar disorder
2.Diagnosed bipolar disorder under stable conventional therapy for at least one month
3.willingness to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
1.Comorbid severe psychiatric or neurological disorders
2.History of substance abuse
3.Current Homeopathic treatment
4.Preganant and lactating individuals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in severity of bipolar symptoms by a standardized clinical scale(Bipolar spectrum diagnostic scale) |
Baseline and end of intervention
3 weeks 6 weeks 9 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life scores as assessed by bipolar spectrum diagnostic scale |
Baseline end of intervention
3weeks 6weeks 9weeks 12weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
not yet recruiting |