A Comparative Clinical Study of AYUSH-LND a coded Ayurvedic Formulation in the Management of Asrigdara (Abnormal Uterine Bleeding)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in the amount of uterine bleeding evaluated by Pictorial Blood Loss Assessment Chart or changes in the duration of bleeding or attainment of normal interval of cycles
研究概览
简要总结
AbnormalUterine Bleeding (AUB) is defined as any alteration in the pattern or volume ofmenstrual blood flow. As per American College of Obstetrics & GynaecologyAbnormal Uterine Bleeding (AUB) is occurred in conditions such as bleedingbetween periods, bleeding after sex, spotting anytime in the menstrual cycle orfor more days than normal, bleeding after menopause. Menstrual cycles that arelonger than 35 days or shorter than 21 days are abnormal and it can occur atany age. Abnormal Uterine Bleeding (AUB) can have many causes vizmiscarriage, ectopic pregnancy,adenomyosis, use of some birth control methods such as an intrauterine device(IUD) or birth control pills, infectionof the uterus or cervix, fibroids, problems with blood clotting, polyps,endometrial hyperplasia, malignancy of the uterus, cervix, or vagina,polycystic ovary syndrome1. AUB is reported to occur in 9 to 14% women betweenmenarche and menopause2. The prevalence varies in each country. InIndia, the reported prevalence of AUB is around 17.9%3.
The proposed drugs are in human use since long back and have noside effects and are considered safer. A clinical study carried out on thecompound Ayurvedic herbal formulations Lodhrasava (30 ml thrice in aday) and Pushyanuga churna (5 gm thrice a day) along with the Swarasa(juice) of Durva (Cynodon dactylon (L.) given for threeconsecutive cycles reported that these drugs are effective in controlling theexcessive bleeding and were found safe4. Clinical efficacy of thesetrail drugs can be attributed mainly to the Lodhra(Symplocos racemosa Roxb.) along with Durva (Cynodon dactylon(L.) Pers.) and other astringent ingriedients of Pushyanuga churna like Jambu(Syzygium cumini), Raktachandana (Pterocarpus santalinus), Kutaja (Holarrhena Antidysenterica), Dhataki (Woodfordiafruiticosa), Manjista (Rubia cordifolia) etc. Another study reported byMeena Parmar et al in 2014 showed the effectiveness of Pushyanuga churna,Lodhra churna, Durva swarasa as a palliative management in Asrigdara(Abnormal Uterine Bleeding)5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age between 18 to 35 years.
- •Women having complaint of excessive bleeding during menstruation by Pictorial blood loss assessment chart score more than 100 points or prolonged bleeding more than 7 days for 3 consecutive cycles
- •Willing and able to participate in the study.
排除标准
- •Associated with reproductive system abnormalities (Excluded clinically and radiologically) Pelvic Inflammatory Disease, Cervicitis, Hydrosalpinx, Endometriosis, Adenomyosis, Fibroid Uterus, Carcinoma of Reproductive Organ etc.
- •Other causes of excessive menstrual bleeding e.g. Thyroid disease, Incomplete Abortion, abortion in last three months, IUCD.
- •4.Subjects 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.
- •Lactating woman.
- •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •Patient with raised liver enzymes twice the upper limit of normal & creatinine more than 1.4 mg%, poorly controlled Hypertension (>160/100 mm of Hg), poorly controlled Diabetes Mellitus{B.S. (F) > 130 mg% and / or Blood Sugar (2 hr.
- •PP) >250 mg% & HbA1c> 6.5%}.
- •Ingestion of any investigational drug within 4 weeks prior to recruitment in the study.
- •Patients who are currently participating in any other clinical trial or participated in past four weeks.
- •H/o hypersensitivity to the trial drug or any of its ingredients.
- •Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
Changes in the amount of uterine bleeding evaluated by Pictorial Blood Loss Assessment Chart or changes in the duration of bleeding or attainment of normal interval of cycles
时间窗: Baseline and end of every cycle up to Six cycles
次要结局
- 1. Change in psychological general wellbeing index(PGWBI)(Baseline, at the end of intervention period and follow-up visit)