comparative study between AYUSH LND ayurvedi formulation with standard drug in heavy and irregular menstrual bleeding

Phase 2

• Conditions: Health Condition 1: - Health Condition 2: N859- Noninflammatory disorder of uterus, unspecifiedHealth Condition 3: N858- Other specified noninflammatory disorders of uterus

• Registration Number: CTRI/2021/04/032565
• Lead Sponsor: INDIAN COUNCIL OF MEDICAL RESEARCH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

1. Hb % < 7gm%.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Change in psychological general wellbeing index(PGWBI)Timepoint: Baseline, at the end of intervention period and follow-up visit