None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Menopausal women aged 45 to 65 years with intact uterus and ovaries. 2) Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postponement of a cycle by more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days 3) Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc. 4) Body mass index 18-35 kg/m2 5) Subject who has given written informed consent to participate in the study and understand the nature of the study 6) Able to read and write in English or any other vernacular language 7) No plan to commence new treatments over the study period. 8) Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1) Participants taking any form of herbal extract in the last 3 months before study entry. 2) Participants with surgical menopause. 3) Participants who are on hormone replacement therapy (HRT) for more than 3 months. 4) Participants with Present active medical, surgical, and gynaecological problems. 5) Participants with a history of alcohol, tobacco dependence, or any substance abuse 6) Participants who had undergone bilateral ovariectomy 7)Participants with history of breast or cervical carcinoma 8) Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 9) Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult 10) Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study 11) Participants with evidence of uncooperative attitude, including poor compliance. 12) Participants with inability to attend follow-up visit 13) Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 14) Patients with known hypersensitivity to Shatavari. 15) Patients who had participated in other clinical trials during the previous 3 months. 16) Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to week 12 in the total and domain specific scores of the Menopause Rating Scale (MRS)Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to week 12 in the total and domain-specific scores of the Menopause-specific Quality of Life Questionnaire (MENQOL).Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the total and domain specific scores of Womens Quality of Life Questionnaire (WOMQOL)Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the total scores of Sleep Quality Scale (SQS)Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the Profile of Mood States (POMS) scoreTimepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the Perceived Stress Scale (PSS-10) scoreTimepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in Hot Flash-Related Daily Interference Scale (HFRDIS)Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in Insomnia Severity Index (ISI)Timepoint: Baseline, Week 4, Week 8, Week 12;Proportion of women with improvement from baseline to week 12 in menopause symptoms (hot flashes and night sweats) on the MRS scale.Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in serum hormones (Sr. Estradiol-E2, Follicle-Stimulating Hormone, Luteinizing Hormone, Progesterone, Testosterone, (AM/PM)Timepoint: Baseline and Week 12;Mean change from baseline to week 12 in hepatic parameters (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin)Timepoint: Baseline and Week 12;Mean change from baseline to week 12 in the renal parameters (serum creatinine, blood urea nitrogen)Timepoint: Baseline and Week 12;Mean change from baseline to week 12 in Thyroid (T3, T4, TSH) parametersTimepoint: Baseline and Week 12;Proportion of patients experiencing Treatment-Emergent Adverse Events (TEAEs) throughout the study periodTimepoint: Baseline, Week 4, Week 8, Week 12;Proportion of patients experiencing Treatment-Emergent Serious A | — |
Countries
Austria, India, Italy, Mexico, Nigeria, South Africa, United States of America
Contacts
Public ContactDr Amit Mutha
Androme TaX, Mens Health Clinic
Outcome results
None listed