CTRI/2019/07/020119尚未招募未知
Clinical Evaluation of the Effect of Shatavariguda and Ashokarishta in the Management of Abnormal Uterine Bleeding (Asrigdara)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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)Women aged between 18 yrs to 40 years.
- •2)Excessive bleeding during menstruation (menstrual blood loss > 80 ml in 1-7 days) having score more than 100 points on Pictorial Blood Loss Assessment Chart (PBLAC) for 3 consecutive cycles/Prolonged menstrual bleeding (more than >7days) for 3 consecutive cycles/Frequent menses-duration of menstrual cycle < 21 days
- •3)Hb% >= 7 gm%
- •4)Patient willing and agrees to participate for three months and signs informed consent
排除标准
- •1)Associated with reproductive system abnormalities (Excluded clinically and radiologically) Polyp, Adenomyosis. Leiomyoma, Malignancy and Hyperplasia, Cervical erosion.
- •2)Other causes of excessive menstrual bleeding e.g. Thyroid disease, IUCD, incomplete abortion
- •3)Blood Dyscrasias; diseases of platelets, clotting factors, diseases of RBCs and WBCs
- •4)Patients on prolonged ( > 6 weeks) drugs which can cause Abnormal Uterine Bleeding e.g. Anticoagulants, Acetylsalicylic acid, Antidepressants (Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants), Hormone Replacement Therapy, Tamoxifen, Phenothiazines, Corticosteroids, Thyroxine, Oral Contraceptives, Herbs; Ginseng, Ginko-biloba, Soya products or any other drugs that may have an influence on the outcome of the study.
- •5)Patient with history of untreated Sexually transmitted Disease or known to be HIV positive.
- •6)Patient with positive pregnancy test/ Lactating woman
- •7)Patient with PAP smear either LSIL or more grade
- •8)Patient with raised liver enzymes twice the upper limit of normal , renal disorder (defines as serum creatinine more than 1.4mg/dl), poorly controlled Hypertension ( >160/100 mm of Hg), poorly controlled Diabetes Mellitus{B.S. (F) > 130 mg% and / or Blood Sugar (PP) >250 mg% & HbA1c > 6.5%}.
- •9)Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •10)H/o hypersensitivity to the trial drug or any of its ingredients.
- •11)Patients who are currently participating in any other clinical trial or participated in past four weeks.
- •12)Ingestion of any investigational drug within 4 weeks prior to the recruitment in the study
- •13)Any other condition which the Principal Investigator thinks may jeopardize the study
研究者
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