Health Condition 1: null- Menopausal Syndrome
Conditions
Interventions
Intervention1: Ashokarishta and Ashwagandha Churna along with Pravala Pishti: ASHOKARISHTA Dose â?? 25 ml twice daily
Duration of therapy-12 weeks Along with ASHWAGANDHA CHURNA Dose â?? 3gm twice daily
Duration of therapy-12 weeks And PRAVALA PISHTI Dose â?? 1 capsule (250 mg) twice daily
Packing form-Plastic jar containing 30 capsules
Duration of therapy-12 weeks.
Intervention2: Ashwagandha Churna: Dose â?? 3gm twice daily
Dosage form â?? Sachet of 3 gm each
Route of Administration â?? oral
Time of Administration-Twice a day ½ an
Sponsors
Central Council for Research in Ayurvedic Sciences CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Females of age between 40 and 55 years 2. Amenorrhoea for more than or equal to 12 months 3. Kupperman menopausal index score more than or equal to 15 4. FSH more than or equal to 20 IU/L 5. Thickness of endometrium less than or equal to 5 mm 6. Willing and able to participate for 14 weeks
Exclusion criteria
Exclusion criteria: 1. Patients with evidence of malignancy 2. Surgical menopause 3. Established cases of any mental illness 4. Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 250 mg/dl) 5. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 6. Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 7. Symptomatic patients with clinical evidence of Heart failure. 8. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 9. Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, hormone replacement therapy etc. or any other drugs that may have an influence on the outcome of the study. 10. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dl). 11. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Inflammatory Bowel Disease, Hypothyroidism or any other condition that may jeopardize the study. 12. Alcoholics and/or drug abusers. 13. H/o hypersensitivity to any of the trial drugs or their ingredients. 14. Patients who have completed participation in any other clinical trial during the past six (06) months. 15. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in the clinical symptoms (using Menopause Rating Scale).Timepoint: At Baseline, Day 14-28-42-56-70-84 and at the end of 14 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| ï??ï? Change in level of Serum Estradiol. ï??ï? Change in Leutinising Hormone ï??ï? Change in level of Follicular Stimulating Hormone ï??ï? Change in quality of Life by using Menopause Specific Quality of Life Questionnare (MENQOL). Timepoint: At Baseline and at Day 84 (Quality of Life assessment done at the end of 14 weeks also). | — |
Countries
India
Contacts
Public ContactDr Pradeep Dua
Central Council for Research in Ayurvedic Sciences (CCRAS)
Outcome results
None listed