CTRI/2019/07/020119
Not yet recruiting
未知
Clinical Evaluation of the Effect of Shatavariguda and Ashokarishta in the Management of Abnormal Uterine Bleeding (Asrigdara)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: N921- Excessive and frequent menstruation with irregular cycle
- Sponsor
- Central Council for Research in Ayurvedic Sciences
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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