Protocol summary
-
Study aim
-
Efficacy of traditional product of Cuscuta campestris and Polypodium vulgare in comparison with placebo in patients with OCD referred to Kerman Psychiatric Clinics in 2021-23
-
Design
-
This clinical trial study had a control group, double blind, randomized using the quadruple block method, on 84 patients.
-
Settings and conduct
-
This double-blind clinical trial is performed on patients with OCD in outpatients referring to Kerman Psychiatric Clinics in 2021-23.
Patients are randomly assigned to two groups after signing the consent form and using the four-block method. 42 patients will be assigned to the traditional product group and 42 to the placebo group. Before starting treatment and after 4 to 8 weeks of taking the drug, and 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
-
42 patients in the traditional product group (250 mg tablets of the traditional product twice a day) along with fluvoxamine tablets (daily dose of 200 mg)
42 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
-
Severity of obsessive symptoms
Quality of Life
General information
-
Reason for update
-
Changing the plant species used in herbal medicine, changing the form of herbal medicine from capsules to tablets, changing the sub-objectives of the study, changing the sample size based on the pilot study, and also changing the sampling date due to the corona epidemic.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200112046092N1
Registration date:
2020-07-11, 1399/04/21
Registration timing:
prospective
Last update:
2023-09-15, 1402/06/24
Update count:
1
-
Registration date
-
2020-07-11, 1399/04/21
-
Registrant information
-
-
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
-
2021-04-09, 1400/01/20
-
Actual recruitment end date
-
2023-03-17, 1401/12/26
-
Trial completion date
-
2023-03-17, 1401/12/26
-
Scientific title
-
The efficacy of the traditional medicine preparation of dodder (Cuscuta campestris Yunck.) 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 campestris Yunck.) 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:
84
Actual sample size reached:
84
-
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 2021-23
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
-
Severity of obsessive symptoms
-
Timepoint
-
Before starting the treatment and after 4 and 8 weeks of taking the drug, the participants are asked to complete the Yale-Brown questionnaire.
-
Method of measurement
-
Yale-Brown questionnaire
2
-
Description
-
quality of life
-
Timepoint
-
Before starting the treatment and after 4 and 8 weeks of taking the drug, the participants are asked to complete the quality of life questionnaire.
-
Method of measurement
-
quality of life questionnaire
Secondary outcomes
1
-
Description
-
Determining the effect of gender on the severity of obsessive symptoms and quality of life in patients with obsessive-compulsive disorders treated with fluvoxamine
-
Timepoint
-
Before starting treatment and after 4 to 8 weeks of taking the drug
-
Method of measurement
-
WHOQOL-BREF questionnaire and Yale-Brown
2
-
Description
-
Determining the effect of age on the severity of obsessive symptoms and quality of life in patients with obsessive-compulsive disorders treated with fluvoxamine
-
Timepoint
-
Before starting treatment and after 4 to 8 weeks of taking the drug
-
Method of measurement
-
WHOQOL-BREF questionnaire and Yale-Brown
3
-
Description
-
Determining the effect of education on the severity of obsessive symptoms and quality of life in patients with obsessive-compulsive disorders treated with fluvoxamine
-
Timepoint
-
Before starting treatment and after 4 to 8 weeks of taking the drug
-
Method of measurement
-
WHOQOL-BREF questionnaire and Yale-Brown
Intervention groups
1
-
Description
-
Intervention group: Herbal drug include Basfaj (Polypodium vulgare) rhizome and aftimon (Cuscuta campestris) The components of the drug are 250 mg tablets (150 mg of Besfaij rhizome powder plus 40 mg of Aftimon aqueous extract, equivalent to 150 mg of Aftimon powder), 55 mg of sucrose and 5 mg of magnesium stearate per tablet). In both groups, fluvoxamine tablets are taken 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 250 mg tablet containing the powdered rhizome of Besfaij and Aftimon was received twice a day (in the morning, fasting and at night at bedtime).
-
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 tablet. The placebo tablet contains 250 mg of cornstarch powder.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
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
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
-
Comments
-