Efficacy and Safety for Cimicifuga/Hypericum Product

Phase 3 Study - Efficacy and Tolerance for the Mixture of Dry Extracts Black Cohosh and Saint John's Worth Versus Isolated Black Cohosh Extract for the Climacteric Symptoms' Control

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01481025

Acronym

Enrollment

210

Registered

2011-11-29

Start date

2011-11-30

Completion date

2012-08-31

Last updated

2011-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perimenopausal Disorder

Keywords

Climacteric, Depression, Herbal treatment

Brief summary

Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.

Detailed description

2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life. The investigators will test the mixture already in the market as GynoPlus and RemifeminPlus, but as each extract has its own particularities the investigators will try CIM/HIP as a unique formulation versus Clifemin® as control and Aplause® as comparator. This protocol was performed for the best of our volunteers.

Interventions

DRUGCimicifuga + Hiperico

1 tablet, 80+450mg/tablet, twice a day for 1-3 months 1 tablet, 80+450mg/tablet, once a day for 3-6 months

DRUGCimicifuga Herbarium

2 caps, 80mg/caps, once a day for 1-3 months 1 caps, 80mg/caps, once a day for 3-6 months

DRUGAplause®

4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Climacteric women 45-60 years old - pre and postmenopausal * Climacteric complains for at least 3 months * No treatments for at least 2 months * MRS score 0.4 or more for at least 3 items * Hamilton's Scale score from 15-23

Exclusion criteria

* Hormon Therapy or any other for the last 3 months * Antidepressive and Hypnotic medication for the last 3 months * Sever illness (cardiac, hepatic, renal, digestive or metabolic) or TSH alteration * History for allergies and hipersensitivity to any component of the drugs formulations * No knowledge for reading or writing * Suicide risk

Design outcomes

Primary

Measure	Time frame	Description
Menopause Rating Scale	8 months	Climacteric Symptoms Evaluation - MRS - Menopause Rating Scale\*

Secondary

Measure	Time frame	Description
Hamilton's Depression Scale	8 months	Questionair for Depression Symptoms
WHOQOL	8 months	Starting Point (T-2) and Ending Point (T6)
Health Numbers	8 months (T-2 to T6)	Starting Point (T0, T1, T3 and T6)

Countries

Brazil

Contacts

Primary ContactMarli Chaves, Secretary

contato@phytopharm.com.br+55 51 8130-8454

Backup ContactKarla F Deud José, PharmD PhD

karla@phytopharm.com.br+55 51 9279-3075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026