CH: Efficacy and Safety for Cimicifuga/Hypericum Product

• Sponsor: Phytopharm Consulting Brazil (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01481025
• Collaborator: Herbarium Laboratorio Botanico Ltda (Industry), Complexo Hospitalar Santa Casa de Misericordia de Porto alegre (Other)
• Enrollment: 210
• Location: 1
• Arms: 3
• Duration (Months): 9
• Patients Per Site Per Month: 23.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perimenopausal Disorder	Drug: Cimicifuga + Hiperico; Drug: Cimicifuga Herbarium; Drug: Aplause®	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Nov 1, 2011
• Anticipated Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Aug 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Menopause Rating Scale [8 months]

   Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale*

Secondary Outcome Measures

1. Hamilton's Depression Scale [8 months]

   Questionair for Depression Symptoms

2. WHOQOL [8 months]

   Starting Point (T-2) and Ending Point (T6)

3. Health Numbers [8 months (T-2 to T6)]

   Starting Point (T0, T1, T3 and T6)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISCMPA's Gynecology Ambulatory	Porto Alegre	RS	Brazil	90020-090

Sponsors and Collaborators

• Phytopharm Consulting Brazil
• Herbarium Laboratorio Botanico Ltda
• Complexo Hospitalar Santa Casa de Misericordia de Porto alegre

Investigators

• Study Chair: Karla F Deud José, Pharm PhD, Phytopharm Consulting Brazil - [e-mail]
• Principal Investigator: Carla Vanin, MD MSc PhD, Federal University of Health Science of Porto Alegre
• Principal Investigator: Raquel P Dibi, MD MSc, Irmandade Santa Casa de Misericórdia de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Phytopharm Consulting Brazil
• ClinicalTrials.gov Identifier: NCT01481025
• Other Study ID Numbers: Cimicifuga/Herbarium
• First Posted: Nov 29, 2011
• Last Update Posted: Nov 29, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Phytopharm Consulting Brazil: Climacteric; Depression; Herbal treatment

Study Results

No Results Posted as of Nov 29, 2011