CTRI/2017/11/010312招募中4 期
Clinical evaluation of Sukumara Ghritam and Bramhi Churnam in the management of menopausal Syndrome - SBMS
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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 endometrial <= 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 diabetes mellitus HbA1C > 6.5%
- •(5)Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
- •(6) Any unstable cardio-vascular diseases.
- •(7) Patients with poorly controlled Hypertension (>= 160 /100 mm Hg)
- •(8)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.
- •(9) Patients with concurrent hepatic disorder
- •(defined as Aspartate Amino Transferase (AST) and /or Alanine Amino Transferase (ALT) > 2 times
- •upper normal limit or Renal Disorders (defined as S. creatinine > upper limit of Lab.value),
- •Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD])
- •(10)Alcoholics and/or drug abusers.
- •(11)H/o hypersensitivity to any of the trial drugs or their ingredients.
- •(12) Patients who have completed participation in any other Clinical trial during the past six (06) months.
- •(13) Any other condition which the Principal Investigator thinks may jeopardize the study.
研究者
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