Treatment of Excessive and prolonged bleeding during menstruation with Elaadi kwatha, Bola Baddha Rasa, Nagakesharaadi Churna

Phase 4

• Conditions: Health Condition 1: N00-N99- Diseases of the genitourinary system

• Registration Number: CTRI/2022/08/044879
• Lead Sponsor: Dr Noor Fathima

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Excessive bleeding during menstruation for more than two consecutive cycles

2. Duration of bleeding >5days

3. Amount of bleeding > 5 pads per day

4. Intervals between two menstrual cycles <21 days

5. Painful menstruation

Exclusion Criteria

1. Vaginal bleeding caused by pregnancy and pregnancy related factors

2. Bleeding due to polycystic ovarian disease

3. Patient having Hemoglobin % <8gms /dL

4. Thyroid dysfunction

5. Patient on hormone replacement therapy in last three months

6. Patient has intrauterine contraceptive device in situ

7. Submucosal fibroids >2cms in size / fibroids with uterine size > 12 weeks / with pressure symptoms

8. Post coital bleeding

9. Post menopausal bleeding

10. Genital tract malignancy

11. Sexually transmitted infections

12. Congenital malformations of female genital system

13. Patients suffering from bleeding disorders like hemophilia, DIC, Von Willebrand disease, ITP, Clotting factors deficiency like prothrombin, factor V,VII,X,XI and Acquired/ congenital platelet function defects

14. Patient taking anti- coagulants like heparin, warfarin, aspirin etc.

15. Systemic disorders like DM, HTN, Cardio vascular, cerebrovascular, Tuberculosis, Chronic kidney disorders, Cirrhosis of liver etc.

16. Patient on chemo/radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sample size : 120 patients Asrigdhara (Abnormal uterine bleeding )with a prevalence rate of 17% in India. <br/ ><br>Statistics will be done based one- way repeated ANOVA test and Pearson correlation coefficient. <br/ ><br>Outcome of treatment: <br/ ><br>�This alternative management which are safe, palatable, easy availability, cost effective, non-hormonal, without side effects and effective in normalization of menstrual flow. <br/ ><br>�To reduce excessive, prolonged bleeding and associated symptoms during menstruation <br/ ><br> <br/ ><br>Timepoint: Each patient will be assessed 4 weeks once for 3 months and follow up every 4 weeks for 3 months.

Secondary Outcome Measures

Name	Time	Method
This clinical study will improve quality life of female in terms of personal family social and work life <br/ ><br>The combination of medications Raktasthambhaka yogas can treat the condition effectively without surgical interventionTimepoint: 12 weeks