The Effect of add on therapy of ultra-high dilution Natrium muriaticum on Depression and Quality of Life of depressed patients in comparison with placebo
In this study we will evaluate the effectiveness of adding homeopathic remedies to conventional treatment of depression. Depressed patients with and without Post-traumatic Stress Disorder( PTSD) due to explosions in Iran-Iraq war with main symptoms of Natrium muriaticum dynamism (Old sadness, Sympathy, hold on past ) with or without headache will be selected.
In the evaluation of the effectiveness of Natrium muriaticum ,in order to control researcher bias and also the patients preference, this study will be conducted in double blind design. The patients and researchers do not know that which cases will receive homeopathy or placebo but another person will give it to the cases. Forty cases will be selected randomly and divided to two groups (control and intervention). In first visit we will explain the study, method and duration of therapy, and they will accept or do not accept the testimonial form. In each visit (every 2-4 weeks) homeopath will take the history, define the remedy and choose it's dose.Then another person will give the remedy or the placebo to the patients accountin to their previous groups.
This process will continue for about 6 months. In this intervention we will use other appropriate remedies by their new or accessory dynamisms. Patients of both homeopathy and control groups should fill out Beck depression and QOL Questionnaire before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011912175N1
Registration date:2013-09-05, 1392/06/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-05, 1392/06/14
Registrant information
Name
Ahmad Mahmoudian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2510
Email address
a_mahmoudian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Isfahan University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of add on therapy of ultra-high dilution Natrium muriaticum on Depression and Quality of Life of depressed patients in comparison with placebo
Public title
Treatment of depression by integration of Homeopathy to conventional Medicine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 and 65.
Depress patients.
Do not have history of drug anaphylaxis.
Do not have psychosis.
Do not suffer from neurological or rheumatic treatment such as Multiple Sclerosis (MS), Vasculitis etc.
Do not have cancer nor receive chemotherapy
Match their symptoms with core dynamism of Natrium muriaticum
Not receive alternative medicine such as herbal medicine and acupuncture in the last month
Age
From 37 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Isfahan university of medical sciences
Street address
Building No4 , Medical university, Hezar jerib Av.
City
Isfahan
Postal code
Approval date
2012-05-28, 1391/03/08
Ethics committee reference number
846/4/د
Health conditions studied
1
Description of health condition studied
Depressive episode
ICD-10 code
F 32
ICD-10 code description
The patient suffers of depressed mood, low energy and decreased activity.
Primary outcomes
1
Description
depression severity
Timepoint
Before and After 6 months of treatment
Method of measurement
The Beck Depression Inventory (BD II),
Secondary outcomes
1
Description
Quality of life
Timepoint
After 6 months of treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Group 1 = Homeopathy
Main remedy is Natrium muriaticum 30CH & 200CH (every two weeks) 5-20 cc
Company; Helios (UK)
Category
Treatment - Drugs
2
Description
Group2 = Placebo = Water
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Psychiatric and Rehabilitaion Hospital
Full name of responsible person
Heidary Habibollah
Street address
Shahid Rajaee Hospital, Najafabad - Isfahan Way
City
Najaf Abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university of Medical sciences, Vice chancellor for research
Full name of responsible person
Adibi Peiman
Street address
Building No.4, Isfahan University of Medical Sciences, Hezar jerib Av
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan university of Medical sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Mahmoudian
Position
Specialist (Internal medicine, Homeopath), Associate professor
Other areas of specialty/work
Street address
Department of Community Medicine, Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jerib Ave.
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2510
Fax
+98 31 1792 2542
Email
a_mahmoudian@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Mahmoudian
Position
Specialist (Associate Professor)
Other areas of specialty/work
Street address
Department of Community Medicine, Faculty of Medicine, Isfahan University Of Medical Sciences , Hezar jerib Ave.