One Week Clinical Study in Subjects With Menopausal Symptoms

Olly, PBC

Status: Completed

Conditions: Healthy; Menopause

Treatments: Dietary Supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06794021

UNLV20241205

Details and patient eligibility

About

The goal of this clinical trial is to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms. The main questions it aims to answer are:

1. To assess the efficacy for improvement of menopausal vasomotor symptoms within 24 hours compared to placebo through Daily Diary and Mobile Application
2. To assess the efficacy for improvement of menopausal vasomotor symptoms hours compared to placebo through days 2-6 Daily Diary and Mobile Application
3. To assess the efficacy of the investigation product on stress/anxiety, mood swings, headaches compared to placebo through days 1-6 and with use of Daily Diary, Mobile Application and validated questionnaires (GCS, MENQOL).
4. To assess the efficacy of the investigation product on mood, stress and sleep at 7 days post treatment using validated questionnaires (PSQI, PSS, POMS)

Enrollment: 40 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Females aged 40 to 65 years,
• Self-reporting menopausal symptoms (> 5 hot flushes per day) and have been present for a minimum of previous 60 days prior to baseline visit.
• Reporting a variable cycle length of > 7 days different from normal
• BMI 20-40 kg/m2
• Able to read, understand, and complete the study questionnaire and records.
• Able to understand the study procedures.
• Able to comply with all study requirements.
• Written informed consent to participate in the study.
• Willingness to actively participate in the study and to come to the scheduled visits.

Exclusion criteria

• Pregnancy or breastfeeding.
• Immune insufficiency
• Women of childbearing potential including those still having a menstrual cycle on a regular basis who are not perimenopausal, menopausal or post-menopausal.
• History of hysterectomy
• Women on hormone replacement therapy
• Use of systemic corticosteroids or immunosuppressant drugs.
• Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
• Employees of the institute or the brand owner or the manufactures of the product
• Cardiovascular-, chronic liver-, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol,
• Alcohol or drug abuse
• Use of hormonal contraceptives within the last 3 months
• Use of other menopause supplements
• BP ≥160/110 mmHg
• Oophorectomy or amenorrhea > two years. Note- Habitual medicine and supplement intake will be registered prior to inclusion in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Oral dietary supplement. Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

Treatment:

Other: Placebo

Dietary Supplement with Proprietary Herbal Extract Blend and GABA

Active Comparator group

Description:

Oral dietary supplement. Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period.

Treatment:

Dietary Supplement: Dietary Supplement with Proprietary Herbal Extract Blend and GABA