None listed
Conditions
Brief summary
Middle-aged women are exposed to a wide range of non-communicable diseases and psychological challenges that can affect their well-being and quality of life. This includes the stage of menopause where woman stops menstruating permanently and loses their reproductive capacity which commonly happens between the ages of 45 and 55. Previous studies have indicated that the quality of life of menopausal women is commonly influenced by levels of depression, self-reported health conditions, incidence of menopausal symptoms, level of education, and marital status. As there are no medicines that can be used safely for the long term in the management of peri and postmenopausal syndromes, a novel therapeutic with minimum side effects is required. Limited yet significant studies have been conducted in testing the efficacy of Tongkat Ali intake among peri and postmenopausal symptoms among women. Therefore, this study aimed to evaluate the effect of Eurycoma longifolia water extract (Physta®) on well -being and quality of life among peri and postmenopausal women. Results of this study will be valuable in uncovering the health benefits of Tongkat Ali as well uplifting the standards of Malaysian local herbs and folk medicines. In relation to menopause and its impact on psychological and emotional well-being that can impact the quality of life of women, searching for natural supplements to be incorporated in the daily diet would be helpful in preventing as well as managing the health issues related to menopausal symptoms is indeed crucial.
Interventions
The study is a randomized, double-blind, placebo-controlled study 12 weeks study involving middle-aged women from 40 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 maltodex
The study is a randomized, double-blind, placebo-controlled study 12 weeks study involving middle-aged women from 40 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).
Sponsors
Biotropics Malaysia Berhad
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 55 Years
Healthy volunteers
No
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)).
Outcome results
None listed