Health Condition 1: N921- Excessive and frequent menstruation with irregular cycle
Conditions
Interventions
Intervention1: Shatavariguda and Ashokarishta: Shatavari Guda- Reference (AFI â?? Part I, 3:27)Dose 10 gms Twice daily after meals with Milk
Ashokarishta Reference (AFI-Part I, 1:5 )Dose 20 ml
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Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion 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 3) Hb% >= 7 gm% 4) Patient willing and agrees to participate for three months and signs informed consen t
Exclusion criteria
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the clinical features of AUB i.e. changes in the amount of uterine bleeding evaluated by PBLAC (Pictorial Blood Loss Assessment Chart)/changes in the duration of bleeding/attainment of normal interval of cycles.Timepoint: Baseline and all follow up visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Psychological General Well Being Index (PGWBI) of subjects.Timepoint: Baseline 90th day and 120th day follow up visits | — |
Countries
India
Contacts
Public ContactDr Rinku Tomar
Central Ayurveda Research Institute for Respiratory Disorders
Outcome results
None listed