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Trial registered on ANZCTR


Registration number
ACTRN12622001341718
Ethics application status
Approved
Date submitted
2/10/2022
Date registered
19/10/2022
Date last updated
19/10/2022
Date data sharing statement initially provided
19/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Eurycoma Longifolia Water Extract (Physta®) on Well-Being of Peri and Postmenopausal Women
Scientific title
The Effects of Eurycoma Longifolia Water Extract (Physta®) on Well-Being of Peri and Postmenopausal Women: A Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study
Secondary ID [1] 307716 0
None
Universal Trial Number (UTN)
Trial acronym
RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 327279 0
Climacteric symptoms 327280 0
Condition category
Condition code
Alternative and Complementary Medicine 324409 324409 0 0
Other alternative and complementary medicine
Reproductive Health and Childbirth 324410 324410 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 324190 0
Treatment: Other
Comparator / control treatment
The control group of the study will receive a 280 mg of maltodextrin capsule which is sensory-identical.
Control group
Placebo

Outcomes
Primary outcome [1] 332565 0
Quality of life by using Menopause-Specific Quality of Life (MENQOL) questionnaire
Timepoint [1] 332565 0
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).
Primary outcome [2] 332831 0
Mood state by using Profile of Mood State (POMS) questionnaire
Timepoint [2] 332831 0
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).
Primary outcome [3] 332832 0
Energy measured using Chalder Fatigue Scale (CFQ) questionnaire
Timepoint [3] 332832 0
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 [1] 413937 0
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).
Timepoint [1] 413937 0
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.
Secondary outcome [2] 414814 0
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.
Timepoint [2] 414814 0
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.

Eligibility
Key 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
Minimum age
45 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size for the trial was determined using G-power software.

Using g-power software, under f-test, MANOVA- repeated measures- within between interaction,
Effect size f(v) = 0.25
Alpha error prob = 0.05
Power = 0.8
Number of groups = 3
Number of measures = 4
Total sample size = 113
To anticipate 10-20% dropout; 150 subjects (50 subjects per trial group)

Statistical Software for Social Sciences (SPSS) will be used to run all descriptive and inferential analyses for all endpoints. The variations between the treatment and the placebo groups will be analyzed by independent student t test and chi squared test. Data will be reported as mean, SD and 95% CI.

The effects of Physta® supplement over time, the effect of group and its interaction will be determined by using mixed design repeated measures ANOVA. Mauchly’s test of Sphericity will be used to analyse the assumption sphericity for each dependent variable. Indication of differences within and between the periods of supplement consumption will be analysed using Bonferroni’s post hoc test. Sub-group analysis will be conducted if required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 25014 0
Malaysia
State/province [1] 25014 0

Funding & Sponsors
Funding source category [1] 311990 0
Commercial sector/Industry
Name [1] 311990 0
Biotropics Malaysia Berhad
Country [1] 311990 0
Malaysia
Primary sponsor type
Commercial sector/Industry
Name
Biotropics Malaysia Berhad
Address
Biotropics Malaysia Berhad
Lot 21, Jalan U1/19, Section 19,
Hicom-Glenmarie Industrial Park,
40150 Shah Alam, Selangor,
Malaysia.
Country
Malaysia
Secondary sponsor category [1] 313474 0
None
Name [1] 313474 0
None
Address [1] 313474 0
None
Country [1] 313474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311412 0
Research Ethics Committee of Universiti Kebangsaan Malaysia (RECUKM)
Ethics committee address [1] 311412 0
Sekretariat Etika Penyelidikan Universiti Kebangsaan Malaysia,
Tingkat 1, Blok Klinikal,
Pusat Perubatan UKM,
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lumpur
Ethics committee country [1] 311412 0
Malaysia
Date submitted for ethics approval [1] 311412 0
01/12/2021
Approval date [1] 311412 0
23/03/2022
Ethics approval number [1] 311412 0
JEP-2021-898

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121006 0
Dr Hanis Mastura Yahya
Address 121006 0
Centre of Healthy Ageing and Wellness (H-CARE),
Faculty Health Sciences,
Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur.
Country 121006 0
Malaysia
Phone 121006 0
+60392897509
Fax 121006 0
Email 121006 0
[email protected]
Contact person for public queries
Name 121007 0
Subashini Muniandy
Address 121007 0
Centre of Healthy Ageing and Wellness (H-CARE),
Faculty Health Sciences,
Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur.
Country 121007 0
Malaysia
Phone 121007 0
+60165191756
Fax 121007 0
Email 121007 0
[email protected]
Contact person for scientific queries
Name 121008 0
Hanis Mastura Yahya
Address 121008 0
Centre of Healthy Ageing and Wellness (H-CARE),
Faculty Health Sciences,
Universiti Kebangsaan Malaysia,
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur.
Country 121008 0
Malaysia
Phone 121008 0
+60392897509
Fax 121008 0
Email 121008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17145Ethical approval    384487-(Uploaded-18-09-2022-20-39-25)-Study-related document.pdf



Results publications and other study-related documents

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