| CTRI Number |
CTRI/2024/06/069264 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Homoeopathic treatment for manic patient |
|
Scientific Title of Study
|
An open label Randomized placebo-controlled trial of Individualized Homoeopathic Medicine Versus Placebo as an Add-On to Standard Treatment in Manic Episode-A Pilot 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 S Karunakara Moorthi |
| Designation |
Research Officer/S-3 |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
OPD NO-4,ROOMNO-9
Department of Psychiatry, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram Post, Kurichy,
Kottayam
KERALA
686532
India |
| Phone |
08281502571 |
| Fax |
|
| Email |
dr.karunakaramoorthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Karunakara Moorthi |
| Designation |
Research Officer/S-3 |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
OPD NO-4,ROOMNO-9
Department of Psychiatry, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram Post, Kurichy,
KERALA
686532
India |
| Phone |
08281502571 |
| Fax |
|
| Email |
dr.karunakaramoorthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Karunakara Moorthi |
| Designation |
Research Officer/S-3 |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
OPD NO-4,ROOMNO-9
Department of Psychiatry, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram Post, Kurichy,
KERALA
686532
India |
| Phone |
08281502571 |
| Fax |
|
| Email |
dr.karunakaramoorthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy
61-65 Institutional area
OPP-D block
Janakpuri
New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65 institutional area
Opp-D block
Janakpuri
New Delhi110058
New delhi |
| Type of Sponsor |
Other [Central Council for Research in Homoeopathy] |
|
|
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 |
| DrSKarunakara Moorthi |
National Homoeopathy Research Institute in Mental Healthg |
OPD NO-4,Room no-9
Department of Psychiatry, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram Post, Kurichy,
Kottayam (Dt), Kerala, India.
Kottayam
KERALA |
08281502571
dr.karunakaramoorthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Ethical Clearance Certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F303||Manic episode in partial remission, (2) ICD-10 Condition: F301||Manic episode without psychotic symptoms, (3) ICD-10 Condition: F302||Manic episode, severe with psychotic symptoms, (4) ICD-10 Condition: F309||Manic episode, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
This group will be treated with individualised Homoeopathic Medicine along with standard treatment .
route of administration-oral.
Duration-2years
selection of medicine,Dosage and repetition of Individalised Homoeopathic medicine will be prescribed as per the homoeopathic guideline.
Standard treatment care will be given by the consultant psychiatrist of this institute based on the symptoms .
Administration -Oral.
duration-2years |
| Comparator Agent |
Placebo |
This group will be treated with placebo along with standard treatment care.
Standard treatment care will be given by the consultant psychiatrist of this institute
Administration-Oral.
Duration-2 years |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both genders between 20-60 years of age diagnosed with mania or manic episodes of Bipolar Affective Disorders with or without psychotic symptoms.
|
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with Bipolar II disorder.
2. Patients with anti-social personality disorder.
3. Mental and behavioural disorders due to
psychoactive Substance abuse.
4. Organic mental disorders such dementia,
delirium.
5. The patients who are taking treatment for mania
from any other system of medicines.
6. Patients who are having suicidal thoughts.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time span for bringing remission from baseline to end of manic symptoms as assessed by the YMRS. |
To compare the time span for bringing remission from baseline to end of manic symptoms as assessed by the YMRS.
If the patients have very severe manic symptoms or tendency to make harm to him or others, he will be admitted in IPD and daily follow-ups will be taken. If symptoms severity or intensity is reduced, the patients will be advised to visit fortnightly for six months. Thereafter, monthly follow-ups will be taken for seventeen months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i)To assess changes in YMRS BPRS.
ii) To find out the improvement in functional impairments with
FAST (Functional Assessment Short Test) between the groups.
iii) Compare the relapse between the groups.
iv) To evaluate reduction of medicine and dosage of Standard Treatment between the groups.
|
2years |
|
|
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)
|
30/06/2024 |
| 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="4"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
|
Title
|
An open label
Randomized placebo-controlled trial of Individualized Homoeopathic Medicine
Versus Placebo as an Add-On to Standard Treatment in Manic Episode-A Pilot
study.
|
|
Short title
|
Homoeopathy verse placebo as an Add-On Treatment
in Manic Episodes.
|
|
Study design
|
An open label Randomized
placebo-controlled trial.
|
|
Study duration
|
4 years 3 months (2 years enrollment + 2 years
intervention + 3 months data analysis and compilation)
|
|
Study centre
|
National Homoeopathy
Research Institute in Mental Health
|
|
Primary Objective
|
i) To
compare the time span for bringing remission from baseline to end of manic
symptoms as assessed by the YMRS.
|
|
Secondary objectives
|
i) To assess changes in YMRS BPRS.
ii) To find out the improvement in functional
impairments with
FAST
(Functional Assessment Short Test) between the groups.
iii) Compare the relapse between the groups.
iv) To evaluate reduction of medicine and dosage
of Standard
Treatment
between the groups.
|
|
Diagnosed by
|
The
diagnosis will be based upon ICD-10 classification of Mental and Behavioural
disorders Diagnostic Criteria for Research and it will be confirmed by
psychiatrist.
|
|
Number of subjects
|
A
minimum sample of 30 cases is required in each group. Considering drop outs,
68 cases (34 in each group) may be enrolled.
|
|
Inclusion criteria
|
1.Patients
of both genders between 20-60 years of age diagnosed
with mania or manic episodes of Bipolar
Affective Disorders
with or without psychotic symptoms.
|
|
Exclusion criteria
|
1. Patients diagnosed with Bipolar II disorder.
2. Patients with anti-social personality
disorder.
3.
Mental and behavioural disorders due to psychoactive
Substance abuse.
4. Organic mental disorders such dementia,
delirium.
5. The
patients who are taking treatment for mania from any other
system of medicines.
6.
Patients who are having suicidal thoughts.
|
|
Study product, dose, route, regimen
|
Individualized homoeopathic treatment, Placebo, Standard
Treatment Care. Regimen as per the
principles of Homoeopathy. Oral route. Minimum dose repetition will be done
according to the condition. The both groups, standard treatment Care, dosage and repetition will solely be
decided by the Consultant Psychiatrist
|
|
Scales/ Questionnaire proposed to be used
|
Ø YMRS
(Young Mania Rating Scale).
Ø BPRS
(Brief Psychiatry Rating Scale).
Ø FAST
(Functional Assessment Short Test
|
|
Statistical methodology
|
The time span taken for remission in both groups will be assessed and
compared using Kaplan Meier estimates, Log Rank test and Cox Regression
Analysis.
The changes in YMRS, BPRS and FAST will be compared using Mixed
Repeated Measures ANOVA.
Chi Square test will be used to compare the no. of cases with relapse
in both the groups.
Changes in dosage of
Standard treatment will be compared using Independent sample t test.
|
|