Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention1: Test Product: Miror BLISS tablets: Dose: 1 tablet per day after dinner (OD)
Route of Administration: Oral
Duration-28 days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Miror Therapeutics Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females from 35-55 years of age. 2. Females having Menopause and Peri-Menopause will be eligible for enrollment. 3. Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study. 4. Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids. 2. Subjects that have participated in any other interventional clinical trial in the previous 90 days. 3. Subjects with known sensitivity to any of the constituents of the investigational product. 4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures. 5. Chronic illness which may influence the outcome of the study. 6. Pregnant/nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Estrogen( Estradiol, Estrone, Estriol) 2. SGA(Subject Global Assessment) Timepoint: Time points: Day 1 and 28 day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MENQOL Timepoint: Time points: Day 1 and 28 day | — |
Countries
India
Contacts
Public ContactPuneet Mittal
CCFT Laboratories
Outcome results
None listed