Placebo controlled randomized trial of Ayush SR in Post Menopausal Syndrome

Central Council for Research in Ayurvedic Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Women of age between 40 to 59 years with history of spontaneous amenorrhoea for Ã¢â?°Â¥ 12 months and post menopausal climacteric symptoms
•2. Modified Kupperman menopausal index weighted score 7 or more.
•3. Willing and able to participate in the study for 4 months and ready to provide informed written consent.

•1. History of hysterectomy or bilateral oophrectomy with or without hysterectomy
•2. Known case of malignancy (cured or with ongoing treatment), ovarian cyst, endometriosis, any benign growth in the reproductive system, abnormal thyroid function, hypoglycemia carcinoid, or pheochromocytoma
•3. History of post coital bleeding or any significant vaginal discharges or other symptoms arising suspicion of malignancy
•4. Patients on prolonged ( > 6 weeks) medication like corticosteroids, antidepressants, anticholinergics, hormone replacement therapy etc. or any other chronic disorder or medication that may have an influence on the outcome of the study
•5.Known cases of co-morbidities like uncontrolled diabetes mellitus (HbA1c >8%), uncontrolled hypertension (BPÃ¢â?°Â¥ 160/100 mm Hg), Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl), pulmonary obstructive disorders, Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit), cardiac dysfunction or Immuno-compromised states like HIV
•6. Alcohol or drug dependency (AUD) (CAGE score >2)
•7. Known hypersensitivity to the study drug ingredient
•8. Patients who have participated in any interventional study currently or have completed participation in any other clinical trial during the past three months since the day of screening

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