Effectiveness and safety of AYUSH-LND (coded Ayurvedic formulation) in the Management of abnormal uterine bleeding (Asrikdara): an Open label single arm prospective clinical study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 560
- 试验地点
- 4
- 主要终点
- Changes in the score denoting amount of menstrual blood loss in women by means of PBLAC (Pictorial Blood Loss Assessment Chart
研究概览
简要总结
Abnormal Uterine Bleeding (AUB) is defined as any alteration in the pattern or volume of menstrual blood flow. As per American College of Obstetrics & Gynaecology Abnormal Uterine Bleeding (AUB) is occurred in conditions such as bleeding between periods, bleeding after sex, spotting anytime in the menstrual cycle or for more days than normal, bleeding after menopause. Menstrual cycles that are longer than 35 days or shorter than 21 days are abnormal and it can occur at any age. It can have a substantial financial and quality-of-life burden.It affects women’s health both medically and socially. In India, the reported prevalence of AUB is around 17.9%. A randomized clinical study was already conducted by CCRAS on Abnormal uterine bleeding using Ayurvedic formulation Tab. AYUSH LND (Analysis was done but results are not published) found statistically more significant than conventional therapy in the heavy menstrual bleeding. Previous study was done in controlled environment, so this study is proposed to conduct on tolerability and treatment adherence in large population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women Age between 18-40 years with heavy menstrual bleeding with no definable organic cause and having complaints of excessive bleeding during menstruation (classified according to PALM – COEIN Classification (bleeding due to coagulopathy, Ovulatory dysfunction, endometrial, iatrogenic and not yet classified will be included.) (Pictorial blood loss assessment chart (PBLAC) score more than 100 points) or prolonged bleeding i.e. bleeding more than 7days for 3 consecutive cycles; ii.
- •Willing and able to comply with schedules visits, treatment, and assessments.
排除标准
- •Hb less than 8 gm.
- •Endometrial Hyperplasia diagnosed radiologically with endometrial thickness more than 20 mm in secretory phase iii.
- •Associated with reproductive system abnormalities (Excluded clinically and radiologically) or diagnosed Pelvic Inflammatory Disease, Cervicitis, Hydrosalpinx, Endometriosis, Fibroid Uterus, Carcinoma of Reproductive Organ, adenomyosis iv.
- •Other causes of excessive menstrual bleeding e.g. Thyroid disease, Incomplete Abortion, abortion in last three months, presence of an IUCD.
- •Participants on prolonged (more than 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 products or any other drugs that may have an influence on the outcome of the study.
- •Lactating woman and women expecting to conceive within next 4 months.
- •Participants who have a past history of Atrial Fibrillation,Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •Participant with raised liver enzymes twice the upper limit of normal & creatinine more than 1.4, poorly controlled Hypertension (more than 160/100 mm of Hg), poorly controlled Diabetes Mellitus{B.S. (F) more than 130 mg and or Blood Sugar (2 hr.
- •PP) more than 250 mg and HbA1c more than 6.5}.
- •Ingestion of any investigational drug within 4 weeks prior to recruitment in the study.
- •Participants who are currently participating in any other clinical trial or participated in past four weeks.
- •Any other condition which the Principal Investigator thinks may jeopardize the study xii.
- •Women who are on hormonal therapy for AUB may be included after washout period.
结局指标
主要结局
Changes in the score denoting amount of menstrual blood loss in women by means of PBLAC (Pictorial Blood Loss Assessment Chart
时间窗: Changes in the score denoting amount of menstrual blood loss in women by means of PBLAC (Pictorial Blood Loss Assessment Chart [Time frame: Baseline, every cycle up to 4 cycles]. | ii. Change in the laboratory safety parameters (LFT, KFT) baseline [Time frame: Baseline, end of the 4th cycles].
ii.Change in the laboratory safety parameters (LFT, KFT)
时间窗: Changes in the score denoting amount of menstrual blood loss in women by means of PBLAC (Pictorial Blood Loss Assessment Chart [Time frame: Baseline, every cycle up to 4 cycles]. | ii. Change in the laboratory safety parameters (LFT, KFT) baseline [Time frame: Baseline, end of the 4th cycles].
次要结局
- No of participants with normal cycles at 120 days (restoration of normal menstrual cycle Duration 5-7 days and interval 21-35 days)(Baseline, every cycle up to 4 cycles)
- Change in score of Menorrhagia Impact Questionnaire.(Baseline, every cycle up to 4 cycles)
- iii. Assessment of treatment adherence through participant self-reported compliance log and used medication containers/strips(Baseline, every cycle up to 4 cycles)
- iv. Assessment of the tolerability of AYUSH-LND (Assessed through reported withdrawal of participants due to incidence of Treatment emergent adverse events (GIT-related AE specifically) during the study period(Baseline, every cycle up to 4 cycles)
- Change in the laboratory parameters from baseline (Complete Blood Count, Test Sr. FSH, Sr. LH, Sr. estradiol)(baseline, and 120th day)
研究者
Vd Priya Ashokrao Thakare
Regional Ayurveda Research Institute, Nagpur