Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: i. 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.
Exclusion criteria
Exclusion criteria: i. Hb less than 8 gm. ii. 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. v. 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. vi. Lactating woman and women expecting to conceive within next 4 months. vii. Participants who have a past history of Atrial Fibrillation,Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. viii. 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}. ix. Ingestion of any investigational drug within 4 weeks prior to recruitment in the study. x. Participants who are currently participating in any other clinical trial or participated in past four weeks. xi. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the score denoting amount of menstrual blood loss in women by means of PBLAC (Pictorial Blood Loss Assessment Chart ii.Change in the laboratory safety parameters (LFT, KFT)Timepoint: 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]. | — |
Secondary
| Measure | Time frame |
|---|---|
| No of participants with normal cycles at 120 days (restoration of normal menstrual cycle Duration 5-7 days and interval 21-35 days)Timepoint: Baseline, every cycle up to 4 cycles;Change in score of Menorrhagia Impact Questionnaire.Timepoint: Baseline, every cycle up to 4 cycles;iii. Assessment of treatment adherence through participant self-reported compliance log and used medication containers/stripsTimepoint: 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 periodTimepoint: Baseline, every cycle up to 4 cycles;Change in the laboratory parameters from baseline (Complete Blood Count, Test Sr. FSH, Sr. LH, Sr. estradiol)Timepoint: baseline, and 120th day | — |
Countries
India
Contacts
Public ContactDr Prashant Shinde
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed