The efficacy of the traditional medicine preparation of dodder (Cuscuta epithymum Murr.) and polypody (Polypodium vulgare) in patients with obsessive-compulsive disorder: A double-blind clinical trial
Efficacy of traditional product of Cuscuta epithymum and Polypodium vulgare in comparison with placebo in patients with OCD referred to Kerman Psychiatric Clinics in 1399
Design
This clinical trial study had a control group, double blind, randomized using the quadruple block method, on 88 patients.
Settings and conduct
This double-blind clinical trial is performed on patients with OCD in outpatients referring to Kerman Psychiatric Clinics in 1399.
Patients are randomly assigned to two groups after signing the consent form and using the four-block method. 44 patients will be assigned to the traditional product group and 44 to the placebo group. Before starting treatment and after 4 to 8 weeks of taking the drug, and four weeks after the end of the study, the Yale-Brown questionnaire and quality of life will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 18 to 70 years
Practicing obsessive compulsive disorder
Be treated with Fluvoxamine
No alcohol or drugs
Lack of physical illnesses such as: diabetes, hypertension, cardiovascular problems
A score above 21 on the Yale-Brown-OCS criterion
Absence of other psychiatric disorders such as bipolar and psychotic disorders
Absence of mental retardation
No pregnancy or lactation
Exclusion criteria:
Drug intolerance
Necessity to take psychiatric drugs other than fluvoxamine or to take measures such as ECT
Intervention groups
44 patients in the traditional product group (500 mg capsules of the traditional product twice a day) along with fluoxamine tablets (daily dose of 200 mg)
44 patients in the placebo group and fluvoxamine
In both groups, fluvoxamine tablets are taken at an average daily dose of 200 mg.
Main outcome variables
time spent
degree of interference
amount of discomfort
resistance
َand the degree of control over obsessive thoughts and actions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046092N1
Registration date:2020-07-11, 1399/04/21
Registration timing:registered_while_recruiting
Last update:2020-07-11, 1399/04/21
Update count:1
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Behnaz Bakhshinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3213 1809
Email address
behnaz.bn1984@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of the traditional medicine preparation of dodder (Cuscuta epithymum Murr.) and polypody (Polypodium vulgare) in patients with obsessive-compulsive disorder: A double-blind clinical trial
Public title
The efficacy of the traditional medicine preparation of dodder (Cuscuta epithymum Murr.) and polypody (Polypodium vulgare) in patients with obsessive-compulsive disorde
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 70 years
Practicing obsessive compulsive disorder
Be treated with Fluvoxamine
No alcohol or drugs
Lack of physical illnesses such as: diabetes, hypertension, cardiovascular problems
A score above 21 on the Yale-Brown-OCS criterion
Absence of other psychiatric disorders such as bipolar and psychotic disorders
Absence of mental retardation
Non-pregnancy and lactation
Exclusion criteria:
Drug intolerance
Necessity to take psychiatric drugs other than fluvoxamine or to take measures such as ECT
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a double blind clinical trial on patients with obsessive-compulsive disorder in outpatients referring to Kerman psychiatric clinics in 1398.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind clinical trial. In this study, after patient consent was signed, all patients participating in this study and the clinical researcher were not aware of the type of medication given to the patient (herbal or placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Medical University Campus,Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.KMU.REC.1399.074
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
1. Spend time on obsessive-compulsive thoughts and actions
Timepoint
Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up.
Method of measurement
Yale-Brown questionnaire
2
Description
Interference rate of obsessive-compulsive disorder
Timepoint
. Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up.
Method of measurement
Yale-Brown questionnaire
3
Description
The degree of discomfort associated with obsessive-compulsive thoughts and actions
Timepoint
. Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up
Method of measurement
Yale-Brown questionnaire
4
Description
Resistance to thoughts and obsessive actions
Timepoint
Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up
Method of measurement
Yale-Brown questionnaire
5
Description
The degree of control over thoughts and obsessive-compulsive behaviors
Timepoint
Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up
Method of measurement
Yale-Brown questionnaire
Secondary outcomes
1
Description
physical health
Timepoint
Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up
Method of measurement
WHOQOL-BREF questionnaire
2
Description
Mental health
Timepoint
Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up
Method of measurement
WHOQOL-BREF questionnaire
3
Description
Social relationships
Timepoint
Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up
Method of measurement
WHOQOL-BREF questionnaire
4
Description
Environmental health
Timepoint
Before starting treatment and after 4 to 8 weeks of taking the drug, people are asked to complete the Yale-Brown questionnaire and quality of life. Questionnaires will be completed again four weeks after the traditional product is discontinued (Week 12) to follow up
Method of measurement
WHOQOL-BREF questionnaire
Intervention groups
1
Description
Intervention group: Herbal drug include Basfaj(Polypodium vulgare) rhizome and aftimon( Cuscuta epithymum Murr.) Ingredients of Rizum Basfaj powder are 150 mg powder, 150 mg powdered aftimon and 200 mg red sugar powder are placed in 500 mg capsules. In both groups, fluvoxamine tablets with an average dose of 200 mg daily (100 mg tablets) twice a day after meals. in the Intervention group, in addition to fluvoxamine tablets, a 500 mg capsule containing powdered Basfaj(Polypodium vulgare) rhizome, aftimon and red sugar is taken twice a day (fasting in the morning and at night when sleeping).
Category
Treatment - Drugs
2
Description
Control group: In this group, the drug used is fluvoxamine tablets with an average dose of 200 mg daily (100 mg tablets) twice a day after meals and placebo capsule.The placebo capsule contains 500 mg of cornstarch powder.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Clinic
Full name of responsible person
Behnaz Bakhshi Nejad
Street address
St.,Jahad Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 1677
Email
behnaz.bn1984@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abass Pardakhti
Street address
Ebn-e-Sina St.,Jahad Blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Behnaz Bakhshi Nejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Jomhuri Eslami Blvd., Faculty of Traditional Iranian Medicine
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0360
Email
behnaz.bn1984@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Behnaz Bakhshi Nejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kerman, Jomhuri Eslami Blvd., Faculty of Traditional Iranian Medicine
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0360
Email
behnaz.bn1984@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
behnaz bakhshi nejad
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Jomhuri Eslami Blvd., Faculty of Traditional Iranian Medicine
City
kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0360
Email
behnaz.bn1984@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be available upon request after publication of the article
When the data will become available and for how long
after publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The request is reviewed on a case-by-case basis
From where data/document is obtainable
Refer to the author's email responsible for the article
What processes are involved for a request to access data/document
The request will be answered within a maximum of two weeks