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Clinical trial

the Effect of Vitamin B 1 on Menstrual Pattern After Insertion of the IUD.

ID
Name
Vitamin B 1 IUD
Description
investigate the effect of vitamin B 1 on menstrual bleeding and spotting after insertion of the IUD.
Trial arms
Trial start
2023-07-30
Estimated PCD
2023-11-30
Trial end
2023-11-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
VITAMIN B1 500mg
VITAMIN B1 (High Potency) 500mg tab every day for 3 months
Arms:
Vitamin B 1
Other names:
VITAMIN B1 500mg @Biovea
intra-uterine contraceptive device
intra-uterine contraceptive device
Arms:
Vitamin B 1, control
Other names:
silverline IUD
Size
200
Primary endpoint
the duration of menstrual bleeding.
3 cycles ( 3 months / one month for each cycle)
Eligibility criteria
Inclusion Criteria: * Females with first time use of the IUD * a history of normal menstrual bleeding with duration of 3 to 7 days without spotting, a menstrual cycle lasting 23 to 35 days, * use of 10 to 14 sanitary pads per cycle before IUD insertion * gravidity ranging between 1 and 4. Exclusion Criteria: * Patients with cardiac, hepatic or renal diseases. * Patients with bleeding disorders. * Patients with systemic diseases.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-08-02

1 organization

1 product

1 indication

Organization
Beni-Suef University
Product
Vitamin B1
Indication
Intrauterine Device Complication