None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Post-Menopausal women aged 55 to 65 years with intact uterus and ovaries. 2. Post-menopausal women (12 or more consecutive months without a menstrual period) 3. Body mass index of 18-35 kg/m2 4. Women who has given written informed consent to participate in the study and understand the nature of the study 5. Able to read and write in English or any other vernacular language 6. No plan to commence new treatments over the study period. 7. Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Less than 12 months of missed menstruation. 2. Participants taking any form of herbal extract in the last 3 months before study entry. 3. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 4. Participants with any 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 or hysterectomy. 7. Participants with history of breast, ovarian or cervical carcinoma. 8. Participants who taking medication that affect bone metabolism, including glucocorticoids, anticonvulsants, bisphosphonates, methotrexate and immunosuppressants. 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 Ashwagandha. 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 MRS (Menopause Rating Scale) scores (total and domain-specific)Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline to week 12 in the MENQOL (Menopause-specific Quality of Life) scores (total and domain-specific)Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the MMSE (Mini-Mental State Exam) scoresTimepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the FSFI (Female Sexual Function Index) scores (total and domain-specific)Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change from baseline to week 12 in the 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 Generalized Anxiety Disorder (GAD-7) scoreTimepoint: Baseline, Week 4, Week 8, Week 12;Change from baseline to week 12 in serum hormones (Sr. Estradiol-E2, Follicle-Stimulating Hormone, Luteinizing Hormone, Progesterone, Testosterone, Salivary Cortisol (AM/PM)Timepoint: Baseline and Week 12;Change in serum calcium, Vitamin D (25-OH), Osteocalcin, C-terminal telopeptide of type I collagen (CTX) from baseline to week 12Timepoint: Baseline and Week 12;Change from baseline to week 12 in hepatic parameters (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin)Timepoint: Baseline and Week 12;Change from baseline to week 12 in the renal parameters (serum creatinine, blood urea nitrogen)Timepoint: Baseline and Week 12;Change in thyroid (T3, T4, TSH) parameters from baseline to week 12Timepoint: Baseline and Week 12;Proportion of patients experiencing Treatment-Emergent Adverse Events (TEAEs) over 12 weeksTimepoint: Baseline, Week 4, Week 8, Week 12;Proportion of patients experiencing Treatment-Emergent Serious Adverse Events (TESAEs) over 12 weeksTimepoint: Baseline, Week 4, Week 8, Week 12 | — |
Countries
India, United States of America
Contacts
Public ContactDr Prashant Ghuge
Shree Vinayak Hospital
Outcome results
None listed