Health Condition 1: N951- Menopausal and female climactericstates Health Condition 2: E663- Overweight
Conditions
Interventions
Intervention1: Cirpusins : Cirpusins 250mg + BioPerine 5mg
Twice a day after food
Control Intervention1: Placebo: Microcrystalline Cellulose 250 mg
Twice a day after food
Sponsors
SamiSabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants must provide a voluntarily written and signed ICF to be screened & enrolled in the study. 2. Participant must be a clinically confirmed post-menopausal women in the age group of 45 to 65 years both inclusive. 3. Must be overweight obese with a body mass index BMI between 25 to 34.9 kg m2 both inclusive. 4. Any Case of self-reported post-menopausal symptoms for the past 3 months like Vasomotor symptoms (hot flashes night sweats sweating. Psychosocial (anxiety depression irritability loneliness Physical (flatulence or gas pains aching in muscle or joints insomnia decrease in physical strength weight gain frequent urination. Sexual (mood changes, vaginal atrophy 5. Participants with MRS severity range from moderate 9to15 to severe 16. 6. Individuals must be in good health with controlled diabetes and hypertension with medications, but without thyroid disease. 7. Participants must be able to consume the investigational product as per the protocol throughout the study period. 8. Have normal vital signs or within clinically acceptable range as considered by the Principal Investigator at the time of screening and follow-up visits. 9. Must not have taken any treatment for PMS and agree to refrain from any other treatments for post-menopause symptoms during the study period. 10. Willing to abide by the protocol and all study related procedures from the beginning till the end of the study.
Exclusion criteria
Exclusion criteria: Induced menopause through surgery such as bilateral oophorectomy or salpingooophorectomy chemotherapy radiation or drugs. 2. Individuals who had undergone a partial or total hysterectomy. 3. Use of any treatment for post-menopausal symptoms. 4. Have a known sensitivity, intolerability or allergy to any of the study products or their excipients. 5. Have a positive medical history of heart disease, renal disease hepatic impairment or active systemic infection. 6. Have uncontrolled high blood pressure greater than160 mmHg systolic or more than or equal to110 mmHg diastolic or thyroid disease despite taking regular medication for the last three months at the time of screening and enrolment. 7. Have Type I or uncontrolled Type 2 diabetes HbA1c morethan 9.5. 8. Use of any weight loss medication, special diets or supplements. 9. History of cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of Cyperus rotundus extract in the management of body weight and improvement in quality of life using Menopausal Rating Scale (MRS) in women after menopause 2. To evaluate the efficacy of Cyperus rotundus extract in the management of body weight and improvement in quality of life using Menopausal Rating Scale MRS in women after menopauseTimepoint: 1. from Day 1 to 91 days 2. from Day 1 to 91 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in BMI & anthropometric measurements hip waist & hip waist ratio. 2. Mean change in Lipid profile . 3. Mean change in Serum hormone levels (FSH, LH Estradiol Progesterone Testosterone 4. Incidence of any AE SAE during the study period. 5. Any abnormal change in the lab results.Timepoint: 1. from Day 1 to 91 days 2.from Day 1 to 91days 3. from Day 1 to 91 days 4. from Day 1 to 91 days 5. from Day 1 to 91 days | — |
Countries
India
Contacts
Public ContactSatish G
Sami-Sabinsa Group Limited
Outcome results
None listed