Health Condition 1: - Health Condition 2: N859- Noninflammatory disorder of uterus, unspecified Health Condition 3: N858- Other specified noninflammatory disorders of uterus
Conditions
Interventions
Intervention1: 1. tab AYUSH LND
2. Tablet IFA: 1. tab AYUSH LND2 tablets 3 times a day for 3 months with plain water after breakfast, lunch and dinner. 250 mg of Each tablet
2.Tablet IFA- 60mg Iron +
Sponsors
INDIAN COUNCIL OF MEDICAL RESEARCH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 35 years. 2. 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 3. Willing and able to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Hb % 2. Associated with reproductive system abnormalities (Excluded clinically and radiologically) Pelvic Inflammatory Disease, Cervicitis, Hydrosalpinx, Endometriosis, Adenomyosis, Fibroid Uterus, Carcinoma of Reproductive Organ etc. 3. 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. 5. Lactating woman. 6. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 7. 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%}. 8. Ingestion of any investigational drug within 4 weeks prior to recruitment in the study. 9. Patients who are currently participating in any other clinical trial or participated in past four weeks. 10. H/o hypersensitivity to the trial drug or any of its ingredients. 11. Any other condition which the Principal Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 cyclesTimepoint: Baseline and end of every cycle up to Six cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in psychological general wellbeing index(PGWBI)Timepoint: Baseline, at the end of intervention period and follow-up visit | — |
Countries
India
Contacts
Public ContactDr Prashant Shinde
RARIMCH Nagpur
Outcome results
None listed