Health Condition 1: N951- Menopausal and female climactericstates
Conditions
Interventions
None listed
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: i. Patient with with amenorrhea of more than or equal to 12 months ii. Kuperman menopausal index score Of ore than or equal to 15 iii. Willing to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients with age less 40 years and more 55 years 2. Level of FSH less than 25.8 IU/L 3. Endometrial thickness more than 5mm 4. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine more than 1.2mg/dl) 5. uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease 6. Patients with endocrine disorders (hypothyroidism Hyperthyroidism hyperparathyroidism Untreated Cushing s syndrome 7. Patients with poorly controlled Hypertension ( more than 160 / 100 mm Hg) 8. Patients who are consuming any drug which is known to affect bone metabolism such as SERMs, bisphosphonates, calcitonin, Vit D (more than 60,000 units) and corticosteroids. 9. Patients with Diabetes Mellitus, Rheumatoid arthritis, Coronary Heart disease 10. Alcoholics and/or drug abusers for more than 3 months, methotrexate anti-convulsants diuretics etc 11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 12. H/o hypersensitivity to any of the trial drugs or their ingredients 13. Patients who have completed participation in any other clinical trial during the past six months.Any other condition that the investigator thinks may jeopardise the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Menopausal symptoms using menopause Rating scale (MRS)Timepoint: at base line, 14th day, 28th day, 42nd 56th , 70th day ,84th day and 112th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Quality of Life index (QOL) using the MENQOL questionnaire & Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) Questionnaire Changes in hematological & biological parameters viz CBC LFT lipid profile KFT serum calcium FSH LH Estradiol Changes in parameters including biomarkers of bone health viz Bone specific alkaline phosphatase SERUM calcium X-ray Lumbosacral spine BMDTimepoint: base line 28th 56th 84th day 112th day At baseline 84th day | — |
Countries
India
Contacts
Public ContactDR BANI RAM MEENA
MSRARI, Jaipur
Outcome results
None listed