Determine the effect of Nigella sativa on hypothyroidism
Design
A randomized, Triple-blind, clinical trial study with a two parallel groups of 21 patients with hypothyroidism in placebo and drug for 2 months
Settings and conduct
42 patients with hypothyroidism who admitted to the Endocrine Clinic at Imam Khomeini Hospital in Tehran were selected according to inclusion criteria and randomly divided into two parallel groups of receiving Nigella sativa and placebo for 2 month. According to the computer based randomization table, medications (placebo and nigella sativa) will be given by patients with a specific Cod. Patients, researcher and analyzers are unaware of the type of medication
Participants/Inclusion and exclusion criteria
1.Hypothyroid patients who are diagnosed with endocrinologist and treated with levothyroxine for at least 2 consecutive visits with 10> TSH>2;
2.Age between 16 and 65 years;
3. Patient's written consent form prior to participation in the study;
4. No history of heart disease, coagulation disorders, autoimmune disorders,; pituitary and hypothalamic problems and kidney and malignant diseases;, other thyroid disorders including Graves;
5. No pregnancy or lactation;
Intervention groups
42 hypothyroid patients under treatment were divided into 2 groups, including (1) drug group(2g/day of Nigella sativa powder equivalent to four capsules 250 mg) and (2) placebo (four 250 mg capsules containing starch powder) group for 2 months with levothyroxine drug.
Main outcome variables
serum concentration ofThyroid stimulating hormone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171113037424N2
Registration date:2019-03-05, 1397/12/14
Registration timing:registered_while_recruiting
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
Maryam Fatemi tekie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 5080
Email address
dr.fatemi78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Oral Consumption of Nigella Sativa with Placebo on Serum TSH in Patients with Hypothyroidism treated with Levothyroxine
Public title
Effect of Nigella Sativa in Hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hypothyroid patients who are diagnosed with endocrinologist and treated with levothyroxine for at least 2 consecutive visits with 10> TSH>2
age beween 16 and 65 years
Patient's written consent form prior to participation in the study
No history of heart disease, coagulation disorders, autoimmune disorders, pituitary and hypothalamic problems and kidney and malignant diseases, and other thyroid disorders such as Graves
No Pregnancy or lactation
Exclusion criteria:
Taking any herbal drug that interferes with Nigella sativa
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of control and intervention groups. Participants will be divided into the control and intervention group using a simple randomization model (computer randomization method) and also according to the random number table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
42 patients with hypothyroidism and undergoing treatment will be selected based on inclusion criteria. According to the computer based randomization table, medications (placebo and nigella sativa) will be given by patients with a specific Cod. Patients, researcher and analyzers are unaware of the type of medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahed university of medical sciences
Street address
No5, Golkar Alley, Wahhag Alley, Mahmoodi street, Shahidmadani Ave, Tehran