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

INTERVENTION: The study is a randomized, double‐blind, placebo‐controlled study 12 weeks study involving middle‐aged women from 45 to 55 years old. The study aim is to determine the effect of Tongkat Ali water extract (Physta®) on overall well‐being of peri and postmenopausal women. Eligible subjects will be selected and randomized into three study groups (A, B or C) to receive one supplement capsule daily, each containing either 50 mg or 100 mg of Tongkat Ali water extract (Physta®) or 280 mg of maltodextrin placebo respectively. Subjects will be required to attend 3 follow up visits (week 0 (baseline), week 6 and week 12) at the study site. Study compliance and adherence to protocol will be monitored by performing capsule counting and with reference to the daily dose diary filled up by the subjects (week 6 and week 12 visits). CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Menopause ;Climacteric symptoms ; ; Menopause ; Climacteric symptoms Reproductive Health and Childbirth ‐ Menstruation and menopause PRIMARY OUTCOME: Energy measured using Chalder Fatigue Scale (CFQ) questionnaire ; [The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. ; 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; [The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. ; At 4 timepoints the outcomes will be measured (Week 0 (Baseline), Week 2, Week 6 and Week 12).] Quality of life by using Menopause‐Specific Quality of Life (MENQOL) questionnaire ; [The trial is conducted for 12 weeks of oral administration of Tongkat Ali Physta supplement. ; At 4 timepoints the outcomes will be measured (Week 0 (Baseline), Week 2, Week 6 and Week 12).] SECONDARY OUTCOME: 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. ] 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). ; [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. ] 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