Efficacy and Safety for Cimicifuga/Hypericum Product (CH)

Phytopharm Consulting Brazil

Status and phase: Unknown; Phase 3

Conditions: Perimenopausal Disorder

Treatments: Drug: Aplause®; Drug: Cimicifuga Herbarium; Drug: Cimicifuga + Hiperico

Study type: Interventional

Funder types: NETWORK; Industry; Other

Identifiers

NCT01481025

Cimicifuga/Herbarium

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 3 patient groups

Cimicifuga+Hiperico

Experimental group

Description:

80 + 450 mg / tablet

Treatment:

Drug: Cimicifuga + Hiperico

Cimicifuga Herbarium

Active Comparator group

Description:

80 mg / caps

Treatment:

Drug: Cimicifuga Herbarium

Aplause®

Active Comparator group

Description:

20 mg / tablet

Treatment:

Drug: Aplause®