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A comparison between the effects of modified Nigella Sativa capsules and a placebo on menstruation occurrence, and the menstrual bleeding duration and volume in polycystic ovary patients with oligomenorrhea and amenorrheae: a randomized double blind clinical trial

Protocol summary

Summary
This is a double blind randomized clinical trial with placebo in which we evaluate the effect of modified Nigella Sativa capsule on the menstrual bleeding frequency, duration and volume in Poly Cystic Ovary (PCO) patients with oligomenorrhea or amenorrhea and compared it with those of placebo. This is a multi-central trial. According to the National Institute of Health criteria, the gynecologist selects eligible women with PCO with oligomenorrhea or amenorrhea; candidates enter the study if do not have any other systemic disease (e.g., diabetes, hyperprolactinemia, thyroid disorders, chronic liver and kidney diseases, and epilepsy) be pregnant or lactating. A sample of 68 patients will randomly be divided into two groups of 34, one group will receive the Nigella Sativa and the other one placebo capsule. First, the hormonal and biochemical tests will be performed on all patients, which will be repeated at the end of the study for patients who show abnormal results. A 2 g/day Black Cumin, 4 capsules of 500 mg, will be taken two times per day for one month. The medication will be stoped if menstruation occurs. The treatment duration will be three months; the medication consumption must be delayed for one week in case the menstruation does not occur, resulting in a four-month treatment duration. The placebo will be prescribed the same as the Nigella Sativa capsule, i.e. 4 capsules for a total of 2 grams. The outcomes of this study are menstruation frequency and the menstrual bleeding duration and volume.

General information

Acronym
PCOS
IRCT registration information
IRCT registration number: IRCT2016041827455N1
Registration date: 2016-06-19, 1395/03/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-19, 1395/03/30
Registrant information
Name
Seyedeh Atieh Naeimi
Name of organization / entity
Traditional Medicine School of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
naimi@guilan.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-12-28, 1394/10/07
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effects of modified Nigella Sativa capsules and a placebo on menstruation occurrence, and the menstrual bleeding duration and volume in polycystic ovary patients with oligomenorrhea and amenorrheae: a randomized double blind clinical trial
Public title
The effect of Nigella Sativa on oligomenorrhea and amenorrhea in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of Polycystic Ovary syndrome by gynecologist, according to the National Institute of Health’s criteria; women aged 18-38 years old with irregular periods; having informed consent; Non-consumer of any hormonal medication and Metformin for at least three months prior the study. Exclusion criteria: Using anti-hypertensive, anti-cholesterol, anti- diabetic, insulin-sensitizing,medication; using aspirin and other anti-clotting medications, oral contraceptive and the anti-prostaglandin medications, parallel consumption of other herbal medications for disease treatment; patient with uncontrolled high blood pressure history, brain stroke, heart attack, cancer, cardiovascular disorders, liver disease, renal and thyroid disorders, type 1 or 2 diabetes; pregnancy and lactation; smoking.
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Ethics Committee in Biomedical research, Shahid Beheshti University of Medical Sciences (IR.SBMU.REC
Street address
Side of Taleghani Hospital, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Approval date
2015-12-27, 1394/10/06
Ethics committee reference number
IR.SBMU.REC.1394.157

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
0ccurance of Menstrual bleeding
Timepoint
Before the intervention,1, 2, 3 and 4 months after the intervention.
Method of measurement
Ask the patient

2

Description
Duration of menstural bleeding
Timepoint
Before intervention and 1,2,3, 4 month after intervention
Method of measurement
Ask the patient and complete tracking form

3

Description
Menstrual blood volume
Timepoint
Before intervention and1,2, 3, 4 month after intervention
Method of measurement
Pictorial Blood Loss Assessment Chart (PBAC)

Secondary outcomes

1

Description
Menstrual cycle length
Timepoint
Before intervention and1,2, 3, 4 month after intervention
Method of measurement
Ask the patient and complete tracking form

2

Description
serum LH
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Serum analysis by ELIZA

3

Description
Total Testosterone
Timepoint
Before intervention and 3 month after intervention
Method of measurement
Serum analysis by ELIZA

Intervention groups

1

Description
Group 1:Nigella Sativa capsule, 4 capsules 500 mg, 2 in the morning and 2 nights during the month, except during the period. if the bleeding did not happen in a month,the drug would be cut off for a week
Category
Treatment - Drugs

2

Description
Group 2: control group who received placebo from starch capsules, 4 capsules 500 mg, 2 in the morning and 2 nights during the month, except during the period if the bleeding did not happen in a month,the drug would be cut off for a week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyedeh Atieh Naeimi
Street address
No.8 Shams Alley, opposite Tavanir station, Vali Asr Street, Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Private clinic of Mrs Soodabe Bioos
Full name of responsible person
Seyedeh Atieh Naeimi
Street address
Charmardan Street, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahmood Mosaddegh
Street address
No.8 Shams Alley, Opposite Tavanir station, Vali Asr Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine, Shahid Beheshti 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
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyedeh Atieh Naeimi
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, opposite Tavanir station, Vali Asr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
naimi@guilan.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz M.D
Position
Traditional medicine specialist, Assistant Professor
Other areas of specialty/work
Street address
No.8 Shams Alley, opposite Tavanir station, Vali Asr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
Tansaz@sbmu.ac.ir, Tansaz_mojgan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyedeh Atieh Naeimi
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, opposite Tavanir station, Vali Asr Street, Tehran
City
Tehran
Postal code
Phone
+98 21 8877 3521
Fax
Email
naimi@guilan.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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