Climacteric syndrome
Conditions
Interventions
Crossover comparison study 1
Group 1: Phase 1 consisted of SMI measurement and blood collection prior to the initiation of the study, which was followed by Melsmon injection (4 mL/day x 2 days/week for 3 weeks). After completion
Sponsors
Melsmon Pharmaceutical Co., Ltd Research Laboratory
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Participants of the study were selected from outpatients, who are diagnosed climacteric syndrome or its related disorders with SMI scores higher than 29. Eligible participants should provide a written informed consent prior to participating in the study and must not have any of the exclusion criteria stated below.
Exclusion criteria
Exclusion criteria: The following subjects. 1) pregnant subjects or those with desire of pregnancy. 2) subjects of breast feeding 3) subjects taking female hormone medications 4) subjects taking medications affecting female hormone levels 5) subjects taking placental extract-containing drugs or supplements. 6) female hormone drugs or drugs affecting the female hormone state used within a month. 7) difficult of providing a written informed consent. 8) suffering from severe systemic disorders. 9) subjects who are under certain medical conditions and judged by doctor incompatible with the study. 10) subjects who have experience of drug allergy. 11) subjects who are judged inappropriate by doctors in the clinic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This was a crossover study including a total of 31 patients which consisted 17 subjects of group 1 and 14 subjects in group 2. A first phase of the study consisted of blood collection and simplified menopausal indices (SMI) from patients of group 1 (or group 2) was measured for each patient before receiving Melsmon (or saline as a placebo). Patients of group 1 then received subcutaneous injection of Melsmon twice a week at a dose of 4 mL, irrespective of body weight, for 3 weeks consecutively. The primary outcome was to investigate the changes of SMIs following Melsmon injection and blood was also collected from all patients. After a washout period of one month blood samples were again collected and SMIs were determined from all patients of group 1. Next, injection of saline as a control of Melsmon was performed for l7 patients of group 1 by the same protocol stated above followed by a month of washout period. 14 patients of group 2 were treated with the same protocol stated group 2 followed by a first injection of saline. SMI scores before and after Melsmon or saline injections were analyzed using a standard crossover statistical analysis by SPSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| A second outcome was to determine whether the levels of alteration of SMI scores are correlated with the levels of oxidative stress or with any other biochemical parameters in peripheral blood. About 10 mL blood was collected from all the subjects of both groups before and after the injection of Melsmon or saline. Plasma and serum were prepared from the blood immediately. Oxidative/anti-oxidative parameters were analyzed and it was determined whether there are correlations between SMI scores and the parameters relevant to oxidative/anti-oxidative states. To determine whether plasma proteins that were related to alterations of SMI scores, 6 biochemical parameters including Alb, ALT, CK, AMY, HDL, and LDL in serum were analyzed. | — |
Countries
Japan
Contacts
Public ContactMahiko Nagase
Kichijoji Traditional Chinese Medicine Clinic. Clinic
Outcome results
None listed