| CTRI Number |
CTRI/2024/08/073093 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of manic patients using individualised homoeopathic medicine in LM potency |
|
Scientific Title of Study
|
Effectiveness of individualised homoeopathic medicine in LM potency in the treatment of manic patients-A single arm prospective 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 Anjana T R |
| Designation |
Post graduate scholar, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health Kottayam |
| Address |
Department of Psychiatry National Homoeopathy Research Institute in Mental Health Sachivothamapuram P O Kurichy Kottayam Kerala India
Kottayam
KERALA
686532
India |
| Phone |
7012140060 |
| Fax |
|
| Email |
tranjana98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Gnnanaprakasham |
| Designation |
Associate Professor , Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Psychiatry National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O Kurichy Kottayam Kerala India
Kottayam
KERALA
686532
India |
| Phone |
9444701176 |
| Fax |
|
| Email |
drgprakashpsy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Gnnanaprakasham |
| Designation |
Associate Professor , Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
Department of Psychiatry National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P O Kurichy Kottayam Kerala India
Kottayam
KERALA
686532
India |
| Phone |
9444701176 |
| Fax |
|
| Email |
drgprakashpsy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathic Research Institute In Mental Health , Kottayam |
|
|
Primary Sponsor
|
| Name |
Dr Anjana T R |
| Address |
Department of Psychiatry National Homoeopathy Research Institute in Mental Health Sachivothamapuram P O Kurichy Kottayam Kerala India 686532 |
| 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 Anjana T R |
National Homoeopathic Research Institute In Mental Health Kottayam |
OPD IPD Camps and peripheral units, department of psychiatry ,National Homoeopathic Research Institute In Mental Health Sachivothamapuram P O Kurichy
Kottayam
KERALA |
7012140060
tranjana98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-National Homoeopathy Research Institute In Mental Health Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F30||Manic episode, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine in LM potency |
Individualised homoeopathic medicine will be given through oral route of administration starting with 0/1 or the lowest available
LM potency followed by the next higher potency as per the need of the case. The dosage will be minimum dose .Upon direction
from the investigator, the pharmacist will dispense the medicine in the following manner - A
single globule (equivalent in size to a poppy seed) of the desired potency, will be dissolved in
120 ml of distilled water. 10 drops of dispensing alcohol will be added to this solution for
preservation purpose. Subsequently, the phial will undergo ten uniformly forceful downward
strokes against its bottom. Repetition of medicine will be according to the instructions outlined
in the literature. Participants or caretakers will be instructed to give ten uniformly forceful
downward strokes to the bottom of the phial, using their hand on a hard surface. Take three
teaspoonfuls (15 ml) of this solution and mix it with eight teaspoonfuls (40 ml) of water in a clean glass, after stirring the solution for each dose of medicine will be taken. one teaspoonful (5
ml) of this solution constitutes one dose.
The medicine will be continued or stopped depending upon the improvement of the patient and
in accordance with homoeopathic principles.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Ages from 18 to 65 years, any gender who have fulfilled the DSM V criteria for Manic
episode.
2. Patients with YMRS score greater than 12.
|
|
| ExclusionCriteria |
| Details |
1. Bipolar II disorder.
2. Organic mental disorders
3. Patients with Suicidal ideations.
4. Personality disorders.
5. Disorders due to Substance abuse
6. Pregnant and lactating women.
7. Patients with serious systemic illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The
reduction of symptoms in mania cases will be assessed with the Youngs mania rating scale at the baseline and at the end of every month. The difference of score obtained at baseline and end of every month of treatment
will be compared |
At baseline ,every 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
11/09/2024 |
| 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)
|
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
|
This study is an open label, single arm, clinical interventional study to determine the effectiveness of Individualized Homoeopathic Medicines in LM potencies in the treatment of manic patients that will be conducted in OPD, IPD, and Peripheral units of the Department of Psychiatry at National Homoeopathy Research Institute in Mental Health, Kottayam. The primary outcome measures will be, the reduction of symptoms; assessed using the Youngs Mania Rating Scale (YMRS) every month. As the study is one of its kind, it aims to make the efforts to offer possibilities for future research in the effectiveness of Individualized Homoeopathic Medicines in LM potency in the treatment of manic patients . |