The Effects of Eurycoma Longifolia Water Extract (Physta®) on Well-Being of Peri and Postmenopausal Wome

Not Applicable

• Conditions: Menopause; Climacteric symptoms; Alternative and Complementary Medicine - Other alternative and complementary medicine; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12622001341718
• Lead Sponsor: Biotropics Malaysia Berhad

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-19
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

a)Women aged 45-55 years
b)Scoring of MENQOL is more than or equal to 61 (higher score indicates the presence of climacteric symptoms)
c)Experience aches at muscles, joints, back of the neck and head (Scores YES” for MENQOL question number 12 or/and 15)
d)Experience tiredness, worn out and lack of energy (Score YES” for MENQOL question number 13 or/and 18)
e)In a stable heterosexual relationship for at least 6 months
f)BMI 20-29.9 kg/m2

Exclusion Criteria

a)Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg)
b)Familial and past medical history or current diagnosis of breast cancer or breast cancer in an identical twin, or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to randomization. Subjects with other cancers in full remission more than 5 years after diagnosis are acceptable with the exceptions of breast cancer or genital organ cancer (e.g., cervical cancer, uterine cancer, endometrial cancer, colorectal cancer or ovarian cancer)
c)Uncontrolled diabetes which include fasting blood sugar of > 10 mM/L
d)Uncontrolled and/or untreated thyroid disorder
e)History or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
f)History or current diagnosis of autoimmune conditions, immunodeficiency, rheumatoid-arthritis or gynecological disease
g)Clinically significant mental depression that is not well-controlled in the opinion of the investigator
h)Subject has undergone major surgery within the past one year prior to the randomization visit, except cholecystectomy, and appendectomy
i)Subject smokes more than 15 cigarettes a day
j)History of alcohol or drug abuse within the past year
k)Subjects with known allergic reactions to Tongkat Ali or any other herbal supplements
l)Women already on hormonal therapy for menopause
m)Women with uninvestigated abnormal uterine bleeding.
n)Women with thickened endometrium on ultrasound (i.e. >5mm (in postmenopausal) and >11mm (premenopausal)).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life by using Menopause-Specific Quality of Life (MENQOL) questionnaire <br>[The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. <br> At 4 timepoints the outcomes will be measured (Week 0 (Baseline), Week 2, Week 6 and Week 12).];Mood state by using Profile of Mood State (POMS) questionnaire<br>[The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. <br> At 4 timepoints the outcomes will be measured (Week 0 (Baseline), Week 2, Week 6 and Week 12).];Energy measured using Chalder Fatigue Scale (CFQ) questionnaire <br>[The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. <br> At 4 timepoints the outcomes will be measured (Week 0 (Baseline), Week 2, Week 6 and Week 12).]

Secondary Outcome Measures

Name	Time	Method
Effects of the Eurycoma longifolia water extract (Physta®) on inflammatory biomarkers & oxidative stress biomarkers. Its a composite secondary outcome to measure the inflammatory biomarkers (iNOS, Cox2) and oxidative stress biomarkers (MDA, LPO). <br>[For this secondary outcome measures, blood test will be done at week 0 and week 12. The plasma samples obtained from blood samples will be used to run the ELISA analysis to assess the respective inflammatory biomarkers (iNOS, Cox2) and oxidative stress biomarkers (MDA, LPO) of subjects. ];Effects of the Eurycoma longifolia water extract (Physta®) on female reproductive hormones (estrogen, progesterone, Testosterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH)). This is a composite secondary outcome. [For this secondary outcome measures, commercial blood tests will be performed at week 0, week 6 and week 12 to analyse the female reproductive hormones. ]