CTRI/2012/05/002662招募中2 期
Clinical Evaluation of Ashokarishta, Ashwagandha Churna and Pravala Pishti in the Management of Menopausal Syndrome. - ACT- MPS-2010
Department of AYUSH Ministry of Health Family Welfare Government of India0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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