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Dry Extract From Chaste Tree Fruits (7-11:1), Extraction Solvent: Ethanol 70% (V/V)

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.

Table of Contents

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.[1]

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.[1]

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.[1]

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.[1]

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[1]

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.[1]

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)[1]

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.

Aspect Details
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

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to determine if primary dysmenorrhea (menstrual cramps) improves in women treated with Vitex agnus-castus BNO 1095 20 mg compared to a placebo over a treatment duration of 3 menstrual cycles.
  • Who is eligible to participate in this study? Women aged 18-49 years with diagnosed primary dysmenorrhea, regular menstrual cycles (24-38 days), and who agree to use specified contraception methods are eligible. Participants must not be pregnant, breastfeeding, or using hormonal contraceptives.
  • What is the dosage of the chaste tree extract used in this trial? The dosage of the chaste tree extract (Vitex agnus-castus BNO 1095) used in this trial is 20 mg per day, administered as a film-coated tablet.
  • How long does the clinical trial last? The clinical trial lasts for approximately 5 menstrual cycles. This includes a screening period, followed by 3 menstrual cycles of treatment, and a safety follow-up period.
  • What is the primary outcome measure of the study? The primary outcome measure is the proportion of patients who respond to treatment, defined as a ≥3-point reduction in peak pelvic pain score during the fifth menstrual cycle compared to baseline, without an increase in the use of standard pain relief medication.

Ongoing Clinical Trials on Dry Extract From Chaste Tree Fruits (7-11:1), Extraction Solvent: Ethanol 70% (V/V)

  • Study on the Effectiveness of Chaste Tree Extract (Vitex agnus-castus BNO 1095) for Women with Menstrual Cramps (Primary Dysmenorrhea)

    Not recruiting

    3 1 1
    Investigated drugs:
    Austria Czechia Germany Hungary Poland Sweden

Glossary

  • Primary Dysmenorrhea: Painful menstrual cramps occurring in the lower abdomen just before or during menstruation, without an underlying medical condition.
  • Vitex agnus-castus: Also known as chaste tree, it's a plant used in herbal medicine, particularly for women's health issues including menstrual disorders.
  • BNO 1095: A specific formulation of Vitex agnus-castus extract used in this clinical trial.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Menstrual Cycle: The regular natural change that occurs in the female reproductive system, typically lasting 24-38 days.
  • Informed Consent: The process by which a patient learns about and understands the purpose, risks, and benefits of a clinical trial before deciding to participate.
  • Inclusion Criteria: The factors that allow someone to participate in a clinical trial.
  • Exclusion Criteria: The factors that prevent someone from participating in a clinical trial.
  • Body Mass Index (BMI): A measure that uses your height and weight to work out if your weight is healthy, calculated by dividing weight in kilograms by height in meters squared.
  • Investigational Medicinal Product (IMP): A pharmaceutical form of an active substance or placebo being tested in a clinical trial.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-chaste-tree-extract-vitex-agnus-castus-bno-1095-for-women-with-menstrual-cramps-primary-dysmenorrhea/