| CTRI Number |
CTRI/2024/09/073442 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic management of generalized anxiety disorder |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicine in the management of generalized anxiety disorder with supportive counselling –a randomized placebo controlled 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 Vasaiya Chhatrasinh Ramanbhai |
| Designation |
Post Graduate Scholar Department Of Psychiatry |
| Affiliation |
National Homeopathy Research Institute in Mental Health |
| Address |
Room no 48
Department Of Psychiatry National Homeopathy Research Institute in Mental Health,
Sachivothamapuram P O, Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9427668750 |
| Fax |
|
| Email |
vasaiya6trasinh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Professor And Head Of Department , Department Of Psychiatry, Research Officer(H), Scientist iii |
| Affiliation |
National Homeopathy Research Institute in Mental Health |
| Address |
Room No 48
Department Of Psychiatry
National Homeopathy Research Institute in Mental Health,
Sachivothamapuram P O, Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Professor And Head Of Department , Department Of Psychiatry, Research Officer(H), Scientist iii |
| Affiliation |
National Homeopathy Research Institute in Mental Health |
| Address |
Room No 48
Department Of Psychiatry
National Homeopathy Research Institute in Mental Health,
Sachivothamapuram P O, Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Institute in Mental Health,Sachivothamapuram(P.O),Kurichy,Kottayam,Kerala 686532, India |
|
|
Primary Sponsor
|
| Name |
Dr Vasaiya Chhatrasinh Ramanbhai |
| Address |
Room No 48
Department Of Psychiatry
National Homoeopathy Institute in Mental Health,Sachivothamapuram P O,Kurichy,Kottayam,Kerala 686532, India |
| 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 Vasaiya Chhatrasinh Ramanbhai |
National Homoeopathy Institute in Mental Health |
Room no 48 Department Of Psychiatry Outpatient Department And In-Patient Department, Camps, And Peripheral Units Of The National Homoeopathy Research Institute In Mental Health, sachivothamapuram P O,Kurichy
Kottayam
KERALA |
9427668750
vasaiya6trasinh@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 |
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 with supportive counselling |
The homoeopathic medicine potency ranging from 30c to 1m will be given 4-6 medicated globules of number 30 in size , dose and frequency of repetition will be according to severity of Symptoms of the patient along with supportive counseling for 6 months from the date of enrollment |
| Comparator Agent |
placebo with supportive counselling. |
placebo 4-6 pills of number 30 in size will be administered along with supportive counselling for 6 months from the date of enrollment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases of any gender between the age group of 18 to 65 years
2. Who fulfilled ICD-10 diagnostic criteria of generalized anxiety disorder
3. GAD -7 scale score more than 7 |
|
| ExclusionCriteria |
| Details |
1. GAD with other psychiatric conditions
2. Participants who are pregnant or lactating
3. Substance-induced anxiety disorder
4. Life-threatening systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of changes in the severity of generalized anxiety disorder is planned to be
done every month by using the HAM-A scale and Beck Anxiety Inventory. |
every month from baseline till the conclusion of study(6th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Improvement of symptoms will be assessed at the every month by using CGI-I
SCALE. |
every month from baseline till the conclusion of study(6th month) |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
14/09/2024 |
| 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 trial is comparing the effectiveness
of individualized homoeopathic medicine in the management of generalized
anxiety disorder with supportive counselling –a randomized placebo controlled
trial that will be conducted in outpatient department
and in-patient department, camps, and peripheral units of the National Homoeopathy
Research Institute in Mental Health Kottayam,kerala.
The primary outcome measures will be the changes in the
severity of generalized anxiety disorder is planned to be done every month by
using the HAM-A scale and Beck Anxiety Inventory.The
secondary outcomes will be The Improvement of symptoms will
be assessed at the every month by using CGI-I SCALE. |