Role of certain oral drugs in heavy menstrual bleeding.

Phase 2

Not yet recruiting

Conditions: Other specified abnormal uterine and vaginal bleeding. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,

Registration Number: CTRI/2021/02/031090

Lead Sponsor: National Institute of Ayurveda

Brief Summary: Dysfunctional uterine bleeding occurs most commonly at the extremes of reproductive age (20% of cases occur in adolescence and 40% in patients over age 40).Various treatments are available in modern medicine such as hormones therapy, anti-fibrinolytic agents, anti-prostaglandins etc. but have not proved their definite efficacy in spite of high cost and side effects. Although the medical therapy is generally used first, excessive menstrual bleeding accounts for two third of all hysterectomies.So, there is great scope of research to find out safe, potent, cost effective remedy from *Ä€yurveda*by addressing the root of the problem thereby improving the quality of life of women. This study will be carried out to evaluate the efficacy of *NÄgakesara CÅ«rnÌ£a* and *KutakÄ« CÅ«rnÌ£a* in *AsrÌ£gdara* and to know about the possible aetiology of *Asrigdara.*Patients will be selected from O.P.D. and I.P.D. of *PrasutiTantra* and *StriRoga* Department of N.I.A., Jaipur as per criteria. Written voluntary informed consent will be taken from each patient before starting the trial. The clinical study will be conducted on minimum hundred clinically diagnosed patients of *AsrÌ£gdara* and randomly divided into two groups. An observational study about the *NidÄna* of *AsrÌ£gdara* will also be carried out by making a questionnaire among minimum two hundred patients. All the patients registered for the present trial will be assessed on the basis of subjective parameters, objective parameters and laboratory investigations and Pictorial blood loss assessment chart (PBLAC) and SF-36 questionnaire for quality of life.

*

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

1. Patients ready to participate in the clinical trial.
1. Patients diagnosed as dysfunctional uterine bleeding.
1. Excessive menstrual bleeding (amount >80 ml) or Prolonged menstrual bleeding (>7 days) with or without heavy flow or Frequent menstrual cycle (interval< 21 days) 4) Patients presenting with inter-menstrual bleeding with or without heavy flow for 2 consecutive cycles.

Exclusion Criteria

1. Patients with chronic systemic illness (Congestive cardiac failure, Hypertension, cirrhosis of liver, Tuberculosis endometritis, severe anaemia, chronic renal disease, Insulin dependent diabetes mellitus etc.).
1. Patients using Intrauterine contraceptive device or oral contraceptive pills (Iatrogenic).
1. Patients with uterine and pelvic pathology (Fibroid size >2 cm, endometriosis, adenomyosis, polyp, high grade cervical erosion, endometrial thickness >20 mm etc.).
1. Congenital malformations of uterus(Septate uterus, double uterus).
1. Benign and malignant growth.
1. Thyroid dysfunction (endocrinal disorders).
1. Patients having bleeding due to abortion, ectopic pregnancy, during puerperium.
1. Patients taking Anti-coagulation therapy and having haematological disorders (Leukemia, Thrombocytopenic Purpura).
1. Postmenopausal bleeding.
1. Sexually transmitted infections/Genital tract infections.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy (reduction in complaints of DUB)	2 months

Secondary Outcome Measures

Name	Time	Method
Any adverse event reported voluntarily, observed or enquired	3 months

Trial Locations

Locations (1): National Institute of Ayurveda, Jaipur
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Dr Sonu
Principal investigator
7597056107
89sonu123@gmail.com