| CTRI Number |
CTRI/2023/12/060980 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study of Homoeopathy in improving the Social Quality of Life and Satisfaction in Generalised Anxiety Disorder. |
|
Scientific Title of Study
|
A Clinical study of Individualized Homoeopathic Medicine in improving the Social Quality of Life and Satisfaction in Generalised Anxiety Disorder. |
| 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 Rajikrishna R C |
| Designation |
PG Scholar, Department Of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Department Of Psychiatry,
Sachivothamapuram(P.O), Kurichy,
Kottayam, Kerala
Kottayam
KERALA
686532
India |
| Phone |
9745528790 |
| Fax |
|
| Email |
rc.rajikrishna@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 |
National Homoeopathy Research Institute in Mental Health,
Department of Psychiatry,
Sachivothamapuram(P.O), Kurichy,
Kottayam, Kerala
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 |
National Homoeopathy Research Institute in Mental Health,
Department of Psychiatry,
Sachivothamapuram(P.O), Kurichy,
Kottayam, Kerala
Kottayam
KERALA
686532
India |
| Phone |
9444701176 |
| Fax |
|
| Email |
drgprakashpsy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram(P.O), Kurichy,
Kottayam, Kerala - 686532 |
|
|
Primary Sponsor
|
| Name |
Dr Rajikrishna R C |
| Address |
National Homoeopathy Research Institute in Mental Health,
PG Scholar,
Sachivothamapuram(P.O),
Kurichy,
Kottayam,
Kerala-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 Rajikrishna R C |
National Homoeopathy Research Institute in Mental Health, Kottayam, Kerala |
OPD, IPD, Camps and Peripheral units, Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram(P.O),
Kurichy,
Kottayam,
Kerala-686532
Kottayam
KERALA |
9745528790
rc.rajikrishna@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, Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
After Enrollment Indicated medicine will be started from 30C potency. Will wait and observe if there
is any progress in the patient. If improvement stops at a period, next medicine will be repeated
according to the need of patient. If no change takes place at all, the case will be retaken and new
remedy will be considered. If any acute complaints arise, acute totality will be taken and the
appropriate remedy will be administered. The duration for the intervention in this study would be of 12 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18-65 years
2.Subjects of both sexes
3.Cases satisfying DSM_-5 diagnostic criteria for GAD
4.Score of Q-LES_Q(sf)≥14 |
|
| ExclusionCriteria |
| Details |
1.Generalized Anxiety Disorder with other Psychiatric co morbidity
2.Subjects undergoing other conventional Psychiatric medication for long period
3.Subjects with other serious systemic diseases
4.Substance induced anxiety disorder
5.Pregnant and lactating women
6.At risk of self-harm or suicide |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome measurement will be done by assessing the changes using QLES-Q(sf)score |
12 months follow up. Q_LES_Q(sf)score every 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The outcome measurement will be done by assessing the Beck Anxiety Inventory scale |
12 month follow up, Beck Anxiety Inventory Scale every month |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
03/01/2024 |
| 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 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
|
The clinical study aims to evaluate the efficacy of Individualized
Homoeopathic medicine in treating Generalized Anxiety Disorder (GAD) and
enhancing social quality of life. Patients with GAD symptoms will be screened,
diagnosed by a psychiatrist, and enrolled after obtaining informed consent.
Detailed case assessments, routine and specific investigations, and
individualized treatment plans using RADAR software and Homoeopathic Materia
medica will follow. The 30C potency remedy will be administered, with
adjustments based on patient progress. Regular reviews at 4-week intervals and
assessments using GAD-7, Beck Anxiety Inventory, and Q-LES-Q(SF) will be
conducted to measure treatment outcomes, focusing on anxiety symptom
alleviation and improvements in overall quality of life and satisfaction. |