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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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24 February 2020 |
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Main ID: |
IRCT20191231045961N1 |
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Date of registration:
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2020-02-06 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of ginger on hypothyroidism
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Scientific title:
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Efficacy of ginger in control of resistant symptom in hypothyroid patient’s under thyroid hormone replacement treatment |
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Date of first enrolment:
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2020-04-17 |
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Target sample size:
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120 |
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Recruitment status: |
Pending |
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URL:
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http://en.irct.ir/trial/44908 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: Using a block size 4 block randomization method based on the list provided by Random Allocation software separately for each patient group, Blinding description: The placebo is given to participants in a color and drug-like odor scheme, and none of the dispensing personnel, the laboratory, and the co-worker except the principal therapist know that each patient received the drug or the medication.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Contact type:
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public
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Name:
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Hamide Ashraf
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Address:
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No. 3, Tohid Ave ; Bagherkhan Blvd
7591984989
Yasuj
Iran (Islamic Republic of) |
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Telephone:
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0098 74 3233667 |
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Email:
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tbsonati94@yahoo.com |
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Affiliation:
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Shiraz University of Medical Sciences |
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Contact type:
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scientific
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Name:
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Hamide Ashraf
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Address:
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No. 3, Tohid Ave ; Bagherkhan Blvd
7591984989
Yasuj
Iran (Islamic Republic of) |
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Telephone:
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0098 74 3233667 |
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Email:
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tbsonati94@yahoo.com |
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Affiliation:
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Shiraz University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: A patient with controlled thyroid dysfunction, who still complains of symptoms
Serum TSH level should be between .5 -5 units
Informed consent of patients to participate in the study
Age range 20-60 years
Body mass index 19-35
Exclusion criteria: Pregnancy
2. Co-infection with other thyroid diseases
3. Any type of malignancy
4. Experience the courage of ginger
5. Liver and kidney failure
6. Diseases related to the hypothalamic pituitary pathway
7. With malabsorption disorders such as celiac disease, IBD, atrophic gastritis
8. Concomitant use of drugs such as phenobarbital, phenytoin, carbamazepine, rifampin, glucocorticoid, estrogen, raloxifene
9- caused by severe mental illness
10- Use warfarin and statins
11. Purpose of pregnancy
Age minimum:
20 years
Age maximum:
60 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypothyroidism.
Other hypothyroidism
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Intervention(s)
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Intervention 1: Intervention group: Ginger capsule 500 mg 2 times a day. Intervention 2: Control group: Placebo.
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Primary Outcome(s)
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Symptoms of refractory symptoms in hypothyroid patients. Timepoint: Baseline and one month after treatment. Method of measurement: ThySRQ questionnaire.
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Secondary Outcome(s)
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Lipid Profile. Timepoint: At baseline and one month later. Method of measurement: chromatography.
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Fasting blood sugar. Timepoint: At baseline and one month later. Method of measurement: chromatography.
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TSH. Timepoint: At baseline and after one month. Method of measurement: chemiluminescence.
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Source(s) of Monetary Support
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Shiraz University of Medical Sciences
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Ethics review
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| Status: |
Approved
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| Approval date: |
07/01/2020
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| Contact name: |
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| Contact address: |
Ethics committee of Shiraz university of Medical Sciences
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Results
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| Results available: |
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| Date of first publication: |
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| Baseline characteristics: |
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| Outcome measures: |
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| IPD sharing plan: |
Undecided - It is not yet known if there will be a plan to make this available |
| IPD sharing description: |
Justification or reason for indecision in sharing IPD is No more information |
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