A clinical study to see the effect of some Ayurvedic formulations in the Menopausal women.

Phase 2

• Conditions: Health Condition 1: null- Menopausal Syndrome

• Registration Number: CTRI/2012/05/002662
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Females of age between 40 and 55 years

2. Amenorrhoea for >= 12 months

3. Kupperman menopausal index score >= 15

4. FSH >= 20 IU/L

5. Thickness of endometrium <= 5 mm

6. Willing and able to participate for 16 weeks

Exclusion Criteria

1. Patients with evidence of malignancy

2. Surgical menopause

3. Established cases of any mental illness

4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)

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 ( >

9. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, hormone replacement therapy etc. or any other drugs that may have an influence on the outcome of the study. 160 / 100 mm Hg)

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 Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢ Change in the clinical symptoms (using Menopause Rating Scale).Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.

Secondary Outcome Measures

Name	Time	Method
â?¢ Change in level of Serum Estradiol. <br/ ><br>â?¢ Change in Leutinising Hormone <br/ ><br>â?¢ Change in level of Follicular Stimulating Hormone <br/ ><br>â?¢ Change in quality of Life by using Menopause Specific Quality of Life Questionnare (MENQOL).Timepoint: MENQOL is done at Baseline, 84th day and at the end of follow up after 16th week. <br/ ><br>FSH, LH and Estradiol is done at Baseline and at 84th day.