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Investigating the effect of Oral capsule of Ziziphora tenuior plant extract on Primary Dysmenorrhoea

Phase 3
Recruiting
Conditions
Primary dysmenorrhea.
Registration Number
IRCT20240506061675N1
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
94
Inclusion Criteria

Have no children
Participants must be between the ages of 18 and 30.
Be Iranian
According to the statement of the person suffering from a known chronic disease such as Diabetes, Hypertension, Underlying heart disease, Infectious disease, liver disease, kidney disease, Epilepsy and Malignancy
She has not taken any medication since three months before the intervention.
Do not use special drugs or supplements
According to the person's statement, she does not have any symptoms such as burning, itching or abnormal secretions from the Vagina and Cervix
Have regular cycles from 22 to 35.
Body mass index should be between 19.8 and 26.
Have a history of primary dysmenorrhoea according to the Visual analog scale during the last 6 months
Students living in Shahid Beheshti Medical Sciences student dormitories in Tehran
The amount of bleeding should be between 3 and 7 days
No bleeding between periods.
There should be no stressful events such as the death of relatives and surgery in the last 6 months.
Do not smoke or drink alcohol.
There is no history of Uterine disorders (Myoma, Bicornuate uterus, Polyps), Ovarian disorders (Ovarian Cyst and Polycystic ovary) or Endometrial hypertrophy and Endometriosis according to recent ultrasounds.

Exclusion Criteria

Take any herbal medicine while studying.
Participants do not want to continue treatment.
Kidney or liver disease or cases that, according to the doctor's opinion, should stop treatment, appear during the research.
Failure to correctly use Ziziphora tenuior capsules or placebo, less than 7 capsules in the first three days of menstruation.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary dysmenorrhea. Timepoint: before the intervention and after the end of the intervention, after each menstrual cycle in two consecutive cycles. Method of measurement: Visual Analogue Scale.
Secondary Outcome Measures
NameTimeMethod
Systemic symptoms associated with primary dysmenorrhea. Timepoint: Before the intervention and after the end of the intervention, after each menstrual cycle in two consecutive cycles. Method of measurement: Verbal multidimensional scoring system.
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