| CTRI Number |
CTRI/2024/09/073215 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of homoeopathic medicine in cases of Post- traumatic stress disorder with psychotherapy in age group of 20- 45 years. |
|
Scientific Title of Study
|
Efficacy of individualised homoeopathic medicine in post- traumatic stress disorder: a single blind, randomized, placebo controlled trial with psychotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1310-7398 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Chaudhary |
| Designation |
MD Student |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College, Parul University |
| Address |
Room no. 405, P.G. Department of Practice of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Waghodia, Vadodara, Gujarat.
A/303 Sai Mangal Building, Plot no. 18, Sector- 8, Near Metro Chemist, Charkop, Kandivali West, Mumbai, Maharashtra- 400067
Vadodara
GUJARAT
391760
India |
| Phone |
7383149444 |
| Fax |
|
| Email |
2204082040001@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirtida Desai |
| Designation |
Professor & Guide |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College, Parul University. |
| Address |
Room no. 404, Department of Practice of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Waghodia, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9574424363 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirtida Desai |
| Designation |
Professor & Guide |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College, Parul University. |
| Address |
Room no. 404, Department of Practice of Medicine, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Waghodia, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9574424363 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College, Parul University, Waghodia, Vadodara. 391760 |
|
|
Primary Sponsor
|
| Name |
Dr. Aarti Chaudhary |
| Address |
Room no. 110, Medicine OPD, Jawaharlal Nehru Homoeopathic Medical College Hospital, Parul University, Waghodia, Vadodara, Gujarat. |
| 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 Aarti Chaudhary |
Jawaharlal Nehru Homoeopathic Medical College Hospital |
Room no.110, Medicine OPD, Jawaharlal Nehru Homoeopathic Medical College Hospital, Waghodia, Vadodara, Gujarat.
Vadodara
GUJARAT |
7383149444
2204082040001@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College (Institutional ethics Committee for Human research) Po. Limda, Ta. Waghodia, Dist. Vadodara, Gujarat- 391760, India. |
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 |
| Intervention |
Homoeopathic Medicine |
Homoeopathic Medicine (30 to 1M dose) will be given to Group A participants on each follow up, that is every 15th day orally for the duration of 3 months alongwith psychotherapy. |
| Comparator Agent |
Placebo |
Placebo will be given to Group B participants on each follow up that is every 15th day orally for the duration of 3 months alongwith psychotherapy. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients covering the diagnostic criteria for PTSD (DSM- 5)
2. All socio- economic status
3. Willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating females
2. Cases of Acute Stress Reaction (symptoms for less than 1 month)
3. Cases with irregular follow up
4. Patients who will need to start any other medication during the course of study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Betterment in health of patient of PTSD |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PTSD Checklist (PCL-5) Score less than 33 |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="0"
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 a randomized, single blind, parallel group trail comparing the efficacy of Individualised Homoeopathic medicine and placebo in cases of Post- traumatic stress disorder along with psychotherapy. The study will be conducted in 40 participants which will be enrolled in Jawaharlal Nehru Homoeopathic Medical College Hospital, Vadodara, Gujarat, India. The cases will be diagnosed with the help of DSM-5 criteria and assessed by the use of PCL- 5 (PTSD Checklist for DSM-5). The study will be conducted in the time duration of 1 year. |