A clinical study to see the effect of some Ayurvedic formulations in patients suffering from Menopause related problems.

Phase 2

• Conditions: Health Condition 1: null- Menopausal Syndrome

• Registration Number: CTRI/2012/03/002538
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

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 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified