ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Menopause

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Reproductive Health and Childbirth

Menstruation and menopause

Alternative and Complementary Medicine

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]

Treatment: Other

Intervention code [2]

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]

Symptoms of Menopause assessed using the MENQOL questionnaire.

Timepoint [1]

Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary outcome [1]

Safety of Investigational products - serum assays for red blood cells, white blood cells and liver function

Timepoint [1]

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]

4005 - New Farm

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Gencor Pacific Ltd. Hong Kong

Address [1]

21-E, Elegance Court
Hillgrove Village
Discovery Bay

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queensland Clinical Trial Network

Ethics committee address [1]

Level 3, 88 Jephson Street
Toowong, QLD, 4066

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/01/2014

Approval date [1]

03/04/2014

Ethics approval number [1]

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

Ms Amanda Rao

Address

Integrated Health Group Pty Ltd
PO Box 68
New Farm QLD 4005

Country

Australia

Phone

+61 414488559

Fax

[email protected]

Contact person for public queries

Name

Amanda Rao

Address

Integrated Health Group Pty Ltd
PO Box 68
New Farm QLD 4005

Country

Australia

Phone

+61 414488559

Fax

[email protected]

Contact person for scientific queries

Name

Amanda Rao

Address

Integrated Health Group Pty Ltd
PO Box 68
New Farm QLD 4005

Country

Australia

Phone

+61 414488559

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23805	Other				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.	Type	Is Peer Reviewed?	Citations or Other Details
3957	Plain language summary	No	The results of the study shown that there was a si... [More Details]
4448	Other files	No	Steels E, Harold M, Adams L, Steele M, Coulson S.A... [More Details]
4449	Study results article	Yes	Steels E, Harold M, Adams L, Steele M, Coulson S.A... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy 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.	2017	https://dx.doi.org/10.1002/ptr.5856
Embase	A double-blind, randomized, placebo-controlled trial evaluating safety and efficacy of an ayurvedic botanical formulation in reducing menopausal symptoms in otherwise healthy women.	2018	https://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.

Trial Review

Documents added manually

Documents added automatically