| CTRI Number |
CTRI/2024/03/064367 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| 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 treatment of stress |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in improving symptoms of post-traumatic stress disorder in individuals aged 18-45 years: A double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-3597 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supriti Mondal |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, OPD no. Psychiatry, PG-2 & Medicine (room 1), 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9123345093 |
| Fax |
|
| Email |
mondalsupriti90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Arpita Basu |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, OPD Psychiatry, PG-2 & Medicine (room 1), 12, Gobinda Khatick Road, Tangra, Kolkata
Kolkata
WEST BENGAL
700046
India |
| Phone |
9830273374 |
| Fax |
|
| Email |
drarpitasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Arpita Basu |
| Designation |
Professor |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica, OPD Psychiatry, PG-2 & Medicine (room 1), 12, Gobinda Khatick Road, Tangra, Kolkata
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, Govt. of West Bengal, 12, Gobinda Khatick
Road, Tangra, Kolkata 700046, West Bengal |
|
|
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 |
| Dr Supriti Mondal |
D. N. De Homoeopathic Medical College and Hospital |
Dept. of Materia Medica, OPD Psychiatry, PG2 (Materia Medica), and Medicine (room 1), 12, Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL |
9123345093
mondalsupriti90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D. N. De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F431||Post-traumatic stress disorder (PTSD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients will receive Cognitive and beahvioral therapy and dietary advice as concomitant care. Duration of therapy: 3 months.
|
| Intervention |
Individualized homoeopathic medicines in centesimal potencies plus concomitant care |
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 in 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. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/ RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines or potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homoeopathy and such instances will be compared between groups. All the enrolled patients will receive Cognitive and beahvioral therapy and dietary advice as concomitant care. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from PTSD [ICD-11 code-6B40] and CPTSD [ICD-11 code-6B41], diagnosed as per DSM-V criteria, (CAPS-5 Score 23-50)
2. Patients aged from 18 to 45 years
3. Patients of either sex and transgender
4. Participants having prior experience or knowledge of the treatment. Ex.- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet |
|
| ExclusionCriteria |
| Details |
1. Patients not providing with informed consent voluntarily
2. A primary psychiatric diagnosis other than PTSD
3. Suicidal tendency, patient on current medications (antidepressants, mood stabilizers or anti-psycotics, regular use of benzodiazepines, opioid based analgesics)
4. Recently commenced psychotherapy
5. Patient unwilling to discontinue the anti-psycotic or any other antidepressant medicine
6. Known clinical uncontrolled systemic disorders
7. Vulnerable population: Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people
8. Patients already suffering from eating disorders
9. Pregnant and puerperal women, lactating mothers
10. Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence using TAPS TOOL
11. Self-reported immune-compromised state
12. Already undergoing homoeopathic treatment for chronic disease within last 6 months
13. Simultaneous participation in any other clinical trial |
|
|
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 |
| Clinician-administered PTSD scale (CAPS-5) score for DSM-5 |
At baseline, every month, up to three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PTSD checklist (PCL-5) score for DSM-5 |
At baseline, every month, up to three months |
| Measure Yourself Medical Outcome Profile, version 2.0 (MYMOP-2) questionnaire |
At baseline, every month, up to three months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/04/2024 |
| 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)
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 - 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
- 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 [mondalsupriti90@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 - NA
|
|
Brief Summary
|
PTSD is a major psychiatric disorder that results from exposure to real or threatened death, serious injury, or sexual assault or other traumatic events. PTSD is a common disorder after exposure to trauma and is one of the serious health concerns that is associated with comorbidity, functional impairment, and increased mortality with suicidal ideations and attempts. The symptoms of PTSD include persistently re-experiencing the traumatic event, intrusive thoughts, nightmares, flashbacks, detachment from oneself or reality, and intense negative emotional (sadness, guilt) and physiological reaction on being exposed to the traumatic reminder. Furthermore, problems with sleep and concentration, irritability, increased reactivity, increased startle response, hypervigilance, avoidance of traumatic triggers also occur. There is a significant impairment in social, occupational, and other areas of functioning. For a patient to be diagnosed as PTSD, the duration of the symptoms must be more than one month. Though he use of homoeopathic medicines is extensive globally to treat PTSD, diligent research evidence in favour of homoeopathy is not well marked. So, we intend to undertake the research to evaluate the efficacy and safety of homoeopathic medicines in the treatment of PTSD. Thus this double-blind, randomized (2:1), placebo-controlled trial using individualized homoeopathic medicines along with concomitant care will be conducted upon 66 patients suffering from PTSD in both out-patient department and in-patient departments of D. N. De Homoeopathic Medical College & Hospital. Primary outcome measure will be CAPS-5 score. PCL-5 and MYMOP-2 will be secondary outcome measures. All outcomes will be measured at baseline, every month and up to 3 months. Group differences will be analized statistically. The results will be published in scientific journals. |