None listed
Conditions
Interventions
Intervention1: Asparagus racemosus: Dose:450mg,Doasgeform:Capusle, Duration 84days, 1 capsule per day after meal
Control Intervention1: Placebo: Dose :450mg,Doasgeform:Capusle,
Duration 84days, 1 cap
Sponsors
Three H LABS Co LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female age 45-65 with Kupperman Index score greater than or equal to 25 2. Those who meet one of the following menopause criteria a. Women with spontaneous amenorrhoea for 12 months after the last menstrual period b. Women with spontaneous amenorrhoea for 6 months with a blood FSH level greater than 30 mIU/mL. 3. Those who voluntarily agrees to participate and signs in informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with a history of hypersensitivity to drugs or food ingredients. 2. Those who have been taking menopausal related medicines health functional food extracts of Salvia miltiorrhiza Rhapontic rhubarb root fermented germinated soybean complex of soybean and hop Lactobacillus acidophilus YT1 Schisandra chinensis pomegranate complex of Cyanchum wilfordii red ginseng pycnogenol French maritime pine bark etc. or herbal medicine continuously within one month prior to screening. 3. Those who have been taking hormone preparations such as female hormones or similar hormone preparations Western horseback riding St. Johnâ??s Wort red clover Agnus castus fruit etc. within 3 months prior to Screening. 4. Those who have been taking estrogen related drugs within 6 months prior to screening. 5. Those undergoing hormone replacement therapy HRT treatment to relieve menopausal symptoms 1 month prior to screening. 6. Those who are taking osteoporosis treatment selective estrogen receptor Modulator bisphosphonate etc. 7. Those who have been using vaginal moisturiser to relief from vaginal dryness. 8. Those with irregular uterine bleeding after 1 year of menopause. 9. Those with clinically significant abnormality confirmed by mammography Breast Imaging Reporting and data system Category 0 or 3 or higher. However in case of BI RADS category 0 registration is possible at the discretion of the examiner. 10. Those with endometrial hyperplasia uterine cancer endometrial cancer breast cancer breast disease symptoms or sex hormone related diseases. 11. Those who have had hysterectomy. 12. Those with endometrial thickness greater than 7 mm by vaginal sonogram. 13. Those with body mass index BMI lower than 18 kg per m2 or greater than 30 kg per m2. 14. Those who have undergone surgery within 6 months prior to screening. 15. Those with severe cerebrovascular disease cerebral infarction cerebral hemorrhage etc. heart disease angina pectoris myocardial infarction heart failure arrhythmia in need of treatment lung disease chronic obstructive pulmonary disease etc. within the last 6 months However those who are clinically stable may participate in the trial at the investigatorâ??s discretion. 16. Participants who have irregular dietary habit and intakes excessive Alcohol caffeine and smoke. 17. Those with a serious dysfunction of the liver alanine and aspartate aminotransferase levels of 3 times the upper limit of normal or kidney creatinine greater than 2.0 mg/dL. 18. Those with hypertension blood pressure greater than or equal to 160/100 mmHg. 19. Those with thyroid disease or TSH level is abnormal or out of the normal range specified by the site 20. Those who have having thyroid related hormone drugs, clonidine anticoagulant or antithrombotic drugs aspirin warfarin clopidogrel etc. within 3 months prior to screening. 21. Those with malignant tumour diagnosed within 3 years prior to screening. 22. Those with a psychologically significant medical history, currently taking psychiatric drugs of antidepressant sleeping pills SSRI Gabapentin Benzodiazepine etc. or current disease schizophrenia Epilepsy anorexia bulimia etc. or a history of alcohol or the other drug abuse. 23. Participants who have participated in another clinical trial within 1 month of visit 1 or plan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: Modified Kupperman Index Total ScoreTimepoint: Screening Visit, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: â?¢ Menopause-Specific Quality of Life Total Score â?¢ Modified Kupperman Index Individual Item Score â?¢ Menopause-Specific Quality of Life Individual Item ScoreTimepoint: Screening Visit, Day 42, Day 84;Secondary Outcomes: â?¢ Osteocalcin â?¢ Bone Specific-ALP (BSAP) â?¢ Vaginal pH â?¢ Vaginal Maturation Index â?¢ Vaginal Thickness â?¢ Lipid Profile (Total cholesterol, Triglyceride, HDL-C, LDL-C) â?¢ Safety EvaluationTimepoint: Screening Visit, Day 84 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Private Limited
Outcome results
None listed