In short
This article explores a clinical trial investigating the use of Dry Extract From Chaste Tree Fruits (7-11:1), Extraction Solvent: Ethanol 70% (V/V), also known as Vitex agnus-castus BNO 1095, for treating primary dysmenorrhea (menstrual cramps). The study aims to determine if this natural extract can effectively reduce pain and improve symptoms in women suffering from menstrual cramps over a treatment period of three menstrual cycles.
At a glance
- Study Drug
- Dry Extract From Chaste Tree Fruits (7-11:1), Extraction Solvent: Ethanol 70% (V/V)
- Brand Name
- Vitex agnus-castus BNO 1095
- Dosage
- 20 mg daily
- Form
- Film-coated tablet
- Target Condition
- Primary Dysmenorrhea (Menstrual Cramps)
- Study Duration
- 3 menstrual cycles (treatment period)
- Participant Age Range
- 18-49 years
- Primary Outcome Measure
- ≥3-point reduction in peak pelvic pain score without increased pain medication use
- Key Inclusion Criteria
- Diagnosed primary dysmenorrhea, regular menstrual cycles (24-38 days)
- Key Exclusion Criteria
- Pregnancy, breastfeeding, use of hormonal contraceptives, secondary dysmenorrhea
What is Chaste Tree Extract?
Chaste Tree Extract, also known as Vitex agnus-castus BNO 1095, is a herbal medication derived from the fruits of the chaste tree. This extract is being studied for its potential benefits in treating various women's health issues, particularly primary dysmenorrhea.
Primary Dysmenorrhea: Understanding the Condition
Primary dysmenorrhea refers to painful menstrual cramps that occur in the lower abdomen just before or during menstruation. This condition is not caused by any underlying pelvic problem and is very common among women of reproductive age.
How Chaste Tree Extract Works for Primary Dysmenorrhea
While the exact mechanism is still being studied, Chaste Tree Extract is believed to influence hormone levels and reduce inflammation, potentially alleviating menstrual pain. The ongoing clinical trial aims to determine if this herbal extract can effectively improve primary dysmenorrhea symptoms compared to a placebo.
Clinical Trial Details
A clinical trial is currently underway to investigate the efficacy of Chaste Tree Extract in treating primary dysmenorrhea. Here are some key details:
- The trial is testing a 20 mg dose of Vitex agnus-castus BNO 1095.
- The treatment duration is 3 menstrual cycles.
- The main goal is to see if the extract can reduce menstrual pain and decrease the need for pain relief medication.
Who Can Use Chaste Tree Extract?
Based on the clinical trial criteria, Chaste Tree Extract may be suitable for:
- Women aged 18-49 years
- Those diagnosed with primary dysmenorrhea
- Women with regular menstrual cycles (24-38 days)
- Individuals not using hormonal contraceptives
Precautions and Contraindications
Chaste Tree Extract may not be suitable for everyone. The following conditions or situations may prevent its use:
- Pregnancy or breastfeeding: Women who are pregnant, planning to become pregnant, or breastfeeding should avoid this medication.
- Hormone-sensitive conditions: Those with a history of estrogen-sensitive cancers or pituitary disorders should consult their doctor before use.
- Allergies: Individuals with hypersensitivity to Vitex agnus-castus or any of the extract's ingredients should not use this product.
- Recent childbirth or miscarriage: Women who have had fewer than 3 menstrual cycles following delivery, abortion, miscarriage, or lactation should not use this extract.
- Certain medications: Those taking dopamine agonists, dopamine antagonists, estrogens, or antiestrogens should avoid this extract.
Dosage and Administration
In the clinical trial, Chaste Tree Extract is being tested as follows:
- Form: Film-coated tablet
- Dosage: 20 mg daily
- Route of administration: Oral use
- Treatment duration: Up to 156 days (approximately 5 menstrual cycles)
It's important to note that this dosage is specific to the clinical trial. Always follow your healthcare provider's instructions regarding dosage and duration of use.