The purpose of this study is to find new ways for the treatment of patients with Obsessive-Compulsive disorder (OCD), with the use of Withania somnifera. This is a randomized, double-blind, placebo-controlled, single center, second phase clinical trial. The study population is 30 patients that are diagnosed with OCD. Inclusion criteria: 1) Diagnosis of OCD according to DSM-IV TR. 2) Treatment with SSRI drugs with adequate dose and duration. Exclusion criteria: 1) Pregnancy. 2) Lactation. 3) Comorbidity with other acute psychological disorders. 4) Drug abuse. 5) Liver and renal disorders. 6) Usage of other drugs that have an effect on OCD (Lithium, Gabapentin, Buspirone...). Sample size: Since this is a pilot study, the sample size is limited to 30 patients (15 in each group). In this study either capsules containing Withania somnifera's freeze dried extract (in treatment group) or capsules containing Lactose (in placebo group) is added to the patient's regimen, and its effect is evaluated. The study is carried out in a 6 weeks course, during which the change in the patient's symptoms is evaluated. The outcome of this study is the effect of Withania somnifera's extract on the severity of OCD symptoms, which is evaluated by "Yale Brown" test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070523079N1
Registration date:2015-08-10, 1394/05/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-10, 1394/05/19
Registrant information
Name
Seyyedeh Pardis Jahanbakhsh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 9270
Email address
jahanbakhshp891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluationthe effcet of Withania somnifera’s ethanolic extract on patient’s with obsessive-compulsive disorder
Public title
Evaluating the effect of Withania Somnifera on obsession
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1)Diagnosis of OCD according to DSM-IV TR.
2) Treatment with SSRI drugs with adequate dose and duration.
Exclusion criteria:
1) Pregnancy.
2) Lactation.
3) Comorbidity with other acute psychological disorders.
4) Drug abuse.
5) Liver and renal disorders.
6) Usage of other drugs that have an effect on OCD (Lithium, Gabapentin, Buspirone...).
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Committee for Medical Research Ethics, Mashhad University of Medical Sciences
Street address
Central Organization of University, Daneshgah St., Mashhad, Iran
City
Mashhad
Postal code
Approval date
2015-01-17, 1393/10/27
Ethics committee reference number
930824
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42.2
ICD-10 code description
Mixed obsessional thoughts and acts
Primary outcomes
1
Description
Severity of OCD symptoms
Timepoint
before intervention, 6 weeks after starting the intervention
Method of measurement
Yale Brown Obsessive Compulsive Scale
Secondary outcomes
empty
Intervention groups
1
Description
Capsuls containing freeze dried ethanolic extracts of Withania somnifera, equivalant to 2 grams of Withania somnifera's roots, divided to 4 times a day ( 500 miligrams each), for 6 weeks
Category
Treatment - Drugs
2
Description
Capsuls similar to the treatment group but without Withania somnifera's ethanolic extract, containing 250 miligrams of lactose, 4 times a day for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pharmaceutical Sciences Reseach Center, Mashhad University of Medical Sciences
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah st.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Pardis Jahanbakhsh
Position
Pharm D student
Other areas of specialty/work
Street address
School of Pharmacy, Ferdowsi University, Vakil Abad Blvd.
City
Mashhad
Postal code
Phone
+98 51 3843 9270
Fax
Email
p.jahanbakhsh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Hooshang Mohammadpour
Position
PhD
Other areas of specialty/work
Street address
Mashhad Pharmacy school, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 915 316 2909
Fax
Email
mohamadpoorAH@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Pardis Jahanbakhsh
Position
Pharm D student
Other areas of specialty/work
Street address
School of Pharmacy, Ferdowsi University, Vakil Abad Blvd.
City
Mashhad
Postal code
Phone
+98 51 3843 9270
Fax
Email
p.jahanbakhsh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)