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Trial registered on ANZCTR


Registration number
ACTRN12615000324516
Ethics application status
Approved
Date submitted
9/02/2015
Date registered
9/04/2015
Date last updated
19/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Double Blinded, Randomised, Placebo-Controlled Study to Evaluate Safety and Efficacy of Two (2) Herbal Formulations in Reducing Menopausal Symptoms in Otherwise Healthy Women.
Scientific title
A Prospective Double Blinded, Randomised, Placebo-Controlled Study to Evaluate Safety and Efficacy of Two (2) Herbal Formulations in Reducing Menopausal Symptoms in Otherwise Healthy Women.
Secondary ID [1] 283851 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 290827 0
Condition category
Condition code
Metabolic and Endocrine 291193 291193 0 0
Normal metabolism and endocrine development and function
Reproductive Health and Childbirth 294523 294523 0 0
Menstruation and menopause
Alternative and Complementary Medicine 294963 294963 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. The Active intervention 1 is a 0 size blue-green hard gelatin capsules containing Tinospora Cardifolia 75mg, Asparagus racemosus 100mg, Withania somnifera 100mg, Commiphora mukul 225mg. (1 capsule, taken twice daily for 3 months)

2. The Active intervention 2 is a 0 size blue-green hard gelatin capsule containing 300mg of a standardised extract of Trigonella foenum graecum (Fenugreek) seed extract and 30mg of the flow agent maltodextrin. (1 capsule, taken twice daily for 3 months)

Compliance is measured by regular follow up (telephone, text and email) and the return of trial bottles (with any unused product) at completion of the trial.
Intervention code [1] 288530 0
Treatment: Other
Intervention code [2] 291188 0
Treatment: Drugs
Comparator / control treatment
The placebo product is a 0 size blue-green hard gelatin capsule containing maltodextrin.
Control group
Placebo

Outcomes
Primary outcome [1] 291180 0
Symptoms of Menopause assessed using the MENQOL questionnaire.
Timepoint [1] 291180 0
Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcome [1] 306195 0
Safety of Investigational products - serum assays for red blood cells, white blood cells and liver function
Timepoint [1] 306195 0
Baseline and week 12

Eligibility
Key inclusion criteria
Heterosexual females aged between 40 and 65 years Experiencing menopausal symptoms
Otherwise healthy
Written informed consent provided
Minimum age
40 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women that have been using hormone replacement or herbal medicines for menopausal symptoms for at least 1 month prior to trial.
Women with a previous history, presence, or suspicion of estrogen-dependent neoplasia, neoplastic disease or treatment for any neoplastic disease within the previous 2 years.
Women that have had a partial or total hysterectomy.
Women that have active or a recent history (in the last 6 months) of thromboembolic disease.
Women that have a history of cerebrovascular accident, stroke, or transient ischemia.
Women that have major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy.
Women that have a known or suspected hypersensitivity to any of the herbal ingredients present in the investigational product.
Women that are taking medication for diabetes, high cholesterol, hypertension, osteoporosis and osteoarthritis, administering laxatives or have digestive disease(s).
Women that are currently using other investigational product(s).
Women that have experienced unintended weight loss of more than 15% of body weight in last six months.
Women with active substance abuse (alcohol or drug dependency).

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)
The potential participants are screened by the medicial monitor for inclusion
in the study.
The eligible participants are enrolled by Investigator and provided with a
"Numbered Container" that is identical to all other containers and contains
the same information on the label, except for the NUMBER.
The investigator is blinded to the product randomized with the numbered
containers labelled prior to delivery to Investigational Site.
Product allocated as participants are enrolled in sequential order (1-180).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
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
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size
Power analysis for frequency of daily hot flushes: p=<0.05, 80% confidence, 25% reduction with SD 4.5 (difference between groups), minimum n= 53 (per group). Taking into account potential drop-outs, 60 will be recruited per group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
5/09/2014
Date of last participant enrolment
Anticipated
31/10/2015
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7668 0
4005 - New Farm

Funding & Sponsors
Funding source category [1] 288501 0
Commercial sector/Industry
Name [1] 288501 0
Gencor Pacific Ltd. Hong Kong
Country [1] 288501 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
Integrated Health Group Pry. Ltd.
Address
Unit 3, 59 Merthyr Road
New Farm Brisbane 4005 QLD
Country
Australia
Secondary sponsor category [1] 287206 0
None
Name [1] 287206 0
Address [1] 287206 0
Country [1] 287206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290359 0
Queensland Clinical Trial Network
Ethics committee address [1] 290359 0
Level 3, 88 Jephson Street
Toowong, QLD, 4066
Ethics committee country [1] 290359 0
Australia
Date submitted for ethics approval [1] 290359 0
27/01/2014
Approval date [1] 290359 0
03/04/2014
Ethics approval number [1] 290359 0

Summary
Brief summary
The aim of this study is to evaluate the safety and efficacy of two herbal formulations in reducing menopausal symptoms in otherwise healthy women.

Participants will be enrolled in the study between September 2014 and October 2015 and provided treatment for 3 months.

All participants are provided with the treatment pack – which includes the product (active intervention 1, active intervention 2 or placebo), a daily symptom diary and a pre-prepared QML pathology form for safety profiling and hormone assessment.
Participants take the medication daily and complete the symptom diary daily for 1 week/month.
At month 1 and month 2, a telephone interview is conducted to confirm compliance and complete the QOL questionnaires.
At month 3, participants repeat the blood test at a QML collection centre and they return to the clinic for final assessment.
There will be regular communication with all participants during the study.

There will be supervision of the trial by a qualified Medical Practitioner / Endocrinologist, A/Prof Warrick Inder who will monitor any adverse events associated with the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45318 0
Ms Amanda Rao
Address 45318 0
Integrated Health Group Pty Ltd
PO Box 68
New Farm QLD 4005
Country 45318 0
Australia
Phone 45318 0
+61 414488559
Fax 45318 0
Email 45318 0
[email protected]
Contact person for public queries
Name 45319 0
Amanda Rao
Address 45319 0
Integrated Health Group Pty Ltd
PO Box 68
New Farm QLD 4005
Country 45319 0
Australia
Phone 45319 0
+61 414488559
Fax 45319 0
Email 45319 0
[email protected]
Contact person for scientific queries
Name 45320 0
Amanda Rao
Address 45320 0
Integrated Health Group Pty Ltd
PO Box 68
New Farm QLD 4005
Country 45320 0
Australia
Phone 45320 0
+61 414488559
Fax 45320 0
Email 45320 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23805Other    Published manuscript

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3957Plain language summaryNo The results of the study shown that there was a si... [More Details]
4448Other filesNo Steels E, Harold M, Adams L, Steele M, Coulson S.A... [More Details]
4449Study results articleYes Steels E, Harold M, Adams L, Steele M, Coulson S.A... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a Proprietary Trigonella foenum-graecum L. De-Husked Seed Extract in Reducing Menopausal Symptoms in Otherwise Healthy Women: A Double-Blind, Randomized, Placebo-Controlled Study.2017https://dx.doi.org/10.1002/ptr.5856
EmbaseA double-blind, randomized, placebo-controlled trial evaluating safety and efficacy of an ayurvedic botanical formulation in reducing menopausal symptoms in otherwise healthy women.2018https://dx.doi.org/10.1016/j.hermed.2018.01.001
N.B. These documents automatically identified may not have been verified by the study sponsor.