Efficacy and Safety for Cimicifuga/Hypericum Product

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Perimenopausal Disorder

Intervention / Treatment
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* Drug: Cimicifuga + Hiperico
* Drug: Cimicifuga Herbarium
* Drug: Aplause®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cimicifuga+Hiperico<br>80 + 450 mg / tablet | Drug: Cimicifuga + Hiperico<br>* 1 tablet, 80+450mg/tablet, twice a day for 1-3 months 1 tablet, 80+450mg/tablet, once a day for 3-6 months<br>|
| Active Comparator: Cimicifuga Herbarium<br>80 mg / caps | Drug: Cimicifuga Herbarium<br>* 2 caps, 80mg/caps, once a day for 1-3 months 1 caps, 80mg/caps, once a day for 3-6 months<br>|
| Active Comparator: Aplause®<br>20 mg / tablet | Drug: Aplause®<br>* 4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menopause Rating Scale | Climacteric Symptoms Evaluation - MRS - Menopause Rating Scale* | 8 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Climacteric, Depression, Herbal treatment