| CTRI Number |
CTRI/2023/03/050248 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| 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 treatment of anxiety in adults |
|
Scientific Title of Study
|
Double-blind, randomized, placebo-controlled trial of add-on individualized homoeopathic medicines with cognitive and behavioural therapy in improving anxiety in adults with generalized anxiety disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1288-8837 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arijit Sen |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College & Hospital |
| Address |
Dept of Materia Medica OPD No PG2 and Dept of Psychiatry
D N De Homoeopathic Medical College & Hospital, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
8240947681 |
| Fax |
|
| Email |
arijitsen16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arpita Basu |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College & Hospital |
| Address |
Dept of Materia Medica OPD No PG2 and Dept of Psychiatry,
D.N. De Homoeopathic Medical College & Hospital, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpita Basu |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College & Hospital |
| Address |
Dept of Materia Medica OPD No PG2 and Dept of Psychiatry,
D.N. De Homoeopathic Medical College & Hospital, 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12,Gobinda Khatick Road, Tangra, Kolkata 700046 |
| Type of Sponsor |
Government 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 |
| Arijit Sen |
D N De Homoeopathic Medical College and Hospital |
Dept of Materia Medica OPD No PG2, Dept of Psychiatry, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
8240947681
arijitsen16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Comparator Agent |
Identical-looking placebos plus cognitive and behavioral therapy (CBT) |
Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol,to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive psychological counselling, cognitive behavioral therapy (CBT) to be administered. Duration of therapy: 3 months. |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies plus cognitive and behavioral therapy (CBT) |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (cH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive psychological counselling, cognitive behavioral therapy (CBT) to be administered. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from GAD (ICD code F41.1) diagnosed as per DSM-V criteria diagnosis confirmed through HAM-A (score 8-23). Initial screening for potential GAD cases will be done by using GAD-2 scoring (GAD 2 score 3 or higher)
2.Age between 18 and 65 years
3.Patients of either sex
4.Literate patients; ability to read English, Hindi and/or Bengali
5.Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires
6.Patients undergoing any treatment for GAD included after discontinuing the same following a washout period of 15 days if the patient agreed. |
|
| ExclusionCriteria |
| Details |
1.Minimal (HAM-A score 7 or less) and severe (HAM-A score 24 or more).
2.A primary psychiatric diagnosis other than GAD.
3.Suicidal tendency, pertinent current medications (anti-depressants, mood stabilizers or anti-psychotics, regular use of benzodiazepines, opioid based analgesics)
4.Three or more failed trials of pharmacotherapy for current GAD episode
5.Recently commenced psychotherapy
6.Patient unwilling to discontinue the antipsychotic or any other antidepressant medicine
7.Known clinical uncontrolled systemic disorder like uncontrolled diabetes, uncontrolled hypertension.
8.Vulnerable population- unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
9.Other uncontrolled or life-threatening illness affecting quality of life or any organ failure
10.Pregnant and puerperal women, lactating mothers
11.Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence
12.Self-reported immune-compromised state
13.Already undergoing homoeopathic treatment for chronic disease within last 6 months.
14.Simultaneous participation in any other clinical trail. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hamilton Anxiety Rating Scale (HAM-A) |
At baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generalized Anxiety Disorder 7 (GAD-7) questionnaire |
At baseline, every month, up to 3 months |
| Hamilton Depression Rating Scale (HDRS) questionnaire |
At baseline, every month, up to 3 months |
| Patient Health Questionnaire (PHQ9) |
At baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
06/03/2023 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None yet, to be published later |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arijitsen16@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Generalized anxiety disorder (GAD) is excessive anxiety and worry, occurring more days than not for at least 6 months, about a number of events. The individual finds it difficult to control the worry. The anxiety and worry are associated with restlessness, being easily fatigued, difficulty concentrating, irritability, muscle tension, sleep disturbance. Anxiety disorders affect over a tenth of the population with increasing incidence. Among anxiety disorders GAD has the highest prevalence, it affects 4–6% of the general population. Homoeopathy may have immense potential to offer in the successful treatment of GAD. We intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of GAD in adults. A double blind, randomized (1:1), placebo-controlled trial will be conducted on 96 adults who are suffering from GAD at the outpatient department of D.N. De Homoeopathic Medical College and Hospital. Assessment will be done by Hamilton Anxiety Rating Scale(HAM-A) [primary Outcome], GAD-7 score, The Hamilton Rating Scale for Depression (HDRS) score, Patient Health Questionnaire (PHQ9) score [secondary Outcomes], all to be measured at baseline, every month, up to 3 months. Comparative analysis will be carried out to detect group differences. |